Medical Policy

Policy Num:       07.002.003
Policy Name:     Percutaneous Revascularization Procedures for Lower Extremity Peripheral Arterial Disease 
Policy ID:           [07.002.003]  [Ac / B / M+ / P+]  [7.01.178]

Review:              November 07, 2024
Next Review:     November 20, 2025
 

Related Policies:

02.001.020 - Endovascular Procedures for Intracranial Arterial Disease (Atherosclerosis and Aneurysms)
07.001.075 - Extracranial Carotid Artery Stenting
08.001.055 - Stem Cell Therapy for Peripheral Arterial Disease

Percutaneous Revascularization Procedures for Lower Extremity Peripheral Arterial Disease

summary

Description

Revascularization (either surgical or percutaneous) is a treatment option for certain individuals with lower extremity peripheral arterial disease. Percutaneous revascularization procedures include balloon angioplasty, stent procedures, and atherectomy. Lithotripsy is proposed as a vessel preparation option to facilitate definitive endovascular treatment in heavily calcified lesions.

Summary of Evidence

For individuals who are adults with symptomatic lower extremity peripheral arterial disease who receive percutaneous revascularization with balloon angioplasty, stent procedures, or atherectomy, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. Multiple studies have demonstrated that percutaneous and surgical revascularization for chronic symptomatic PAD can improve symptoms and quality of life in individuals who have not responded to guideline directed medical treatment, including structured exercise. Guidelines recommend that the choice to proceed to revascularization and selection of procedure should be a shared decision-making process, based on clinical presentation, including severity of symptoms and anticipated natural history; degree of functional limitation and QOL impairment; response to medical therapy, including structured exercise; and the likelihood of a beneficial short- and longer-term outcome, balanced against potential short-term (eg, bleeding, infection, major adverse cardiac events), and longer-term procedural risk. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with chronic limb-threatening ischemia (CLTI) who receive percutaneous revascularization with balloon angioplasty, stent procedures, or atherectomy, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. Revascularization is considered the standard treatment for patients with CLTI to minimize tissue loss and preserve a functional limb and ambulatory status. Both endovascular and surgical revascularization have been demonstrated to be effective treatments for preventing amputation in CLTI. In a systematic review of 13 studies of patients with CLTI enrolled in medical and angiogenic therapy trials who did not receive revascularization, a 22% all-cause mortality rate and a 22% rate of major amputation at a median follow-up of 12 months were observed. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with acute limb ischemia who receive percutaneous revascularization with balloon angioplasty, stent procedures, or atherectomy, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. A systematic review consisting of randomized controlled trials and observational studies demonstrated surgical revascularization is an effective treatment in patients with acute limb ischemia. Thrombolysis was associated with a higher incidence of major vascular events compared to surgical treatment (6.5% vs 4.4%). Both thrombolysis and surgery have comparable limb salvage rates, but thrombolysis carries a higher risk of hemorrhagic complications. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with symptomatic lower extremity peripheral arterial disease (PAD) who receive percutaneous revascularization using lithotripsy, the evidence includes 1 RCT and nonrandomized studies. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. The RCT demonstrated primary patency at 1 year was superior in the lithotripsy group compared to the control group (80.5% vs 68.0%, P=.017). A major limitation of the study was a lack of comparison to other percutaneous revascularization procedures. The nonrandomized studies are limited by their lack of a control group, small sample sizes, and heterogeneity in clinical and procedural characteristics. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are adults with asymptomatic lower extremity peripheral arterial disease (PAD) who receive percutaneous revascularization using any procedure, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. Although some individuals with asymptomatic PAD will progress to symptomatic disease, there is no evidence that performing early invasive revascularization procedures leads to a reduction in the development of symptomatic disease. Further, there is evidence that undergone a revascularization procedure are at increased risk of subsequent complications, including the need for additional subsequent revascularization procedures. Therefore, the risks of the procedure do not outweigh any proposed benefits. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine whether percutaneous revascularization procedures improve the net health outcome in individuals who have lower extremity peripheral arterial disease.

Policy statements

Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy in individuals with chronic symptomatic lower extremity peripheral arterial disease (see Policy Guidelines) may be considered medically necessary when the following criteria are met:

• Functionally limiting claudication (see Policy Guidelines); AND

• Inadequate response to guideline-directed management and therapy (GDMT), including structured exercise; AND

• Potential benefits of revascularization on quality of life, walking performance, and functional status outweigh the risks and durability of the intervention and possible need for repeated procedures (see Practice Guidelines).

Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for treatment of chronic limb-threatening ischemia may be considered medically necessary.

Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy for treatment of acute limb ischemia may be considered medically necessary.

Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy in individuals with asymptomatic lower extremity peripheral arterial disease may be considered medically necessary if needed for the safety, feasibility, or effectiveness of other invasive, clinically necessary, life-saving procedures (e.g., transfemoral aortic valve replacement, mechanical circulatory support, endovascular aortic aneurysm repair).

Percutaneous revascularization using balloon angioplasty, stent procedures, or atherectomy in individuals with asymptomatic lower extremity peripheral arterial disease is considered investigational in all other situations.

Percutaneous revascularization using lithotripsy in individuals with lower extremity peripheral arterial disease is considered investigational in all situations.

Policy Guidelines

Chronic Symptomatic Peripheral Arterial Disease

Diagnostic testing for suspected peripheral arterial disease (PAD) requires a multi-faceted approach that incorporates history and physical examination, ankle-brachial index (ABI), and additional physiological testing, as well as noninvasive and potentially invasive (angiography) imaging. Individuals with chronic symptomatic PAD report claudication or other non-joint-related exertional leg symptoms that limit walking performance.

Functional Status

Functional status is defined as an individual's ability to meet basic needs, fulfill usual roles, and maintain health and well-being (activities of daily living). Walking ability and performance, and mobility are components of functional status. Treadmill exercise ABI testing can be used to objectively assess functional status and walking performance. Among individuals with chronic symptomatic PAD, this exercise assessment can be used as a baseline measure of functional status and for evaluation of response to therapy.

Structured Exercise Programs for Peripheral Arterial Disease

A structured exercise program is an exercise program planned by a qualified health care professional that provides recommendations for exercise training with a goal of improving functional status over time. The program provides individualized recommendations for frequency, intensity, time, and type of exercise. Structured exercise programs are classified as supervised exercise therapy or structured community-based exercise programs. In supervised exercise therapy, training is performed for a minimum of 30 to 45 minutes per 60-minutes session. Supervised sessions are performed at least 3 times per week for a minimum of 12 weeks.

Shared Decision Making

Clinical practice guidelines state, "Patient-centered discussions are critical in making appropriate decisions regarding revascularization and for building a trusting longitudinal relationship. More than 70% of patients prefer to have an active role in determining their treatment plan for claudication. Such discussions should be undertaken when considering whether to undergo a revascularization procedure, its timing, and approach for revascularization (ie, endovascular or surgical), and should take into account the patient’s goals, treatment preferences, and perception of risk. Patient engagement is also essential to facilitate smoking cessation, medication adherence, and participation in structured exercise."^1,

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration (FDA) approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Peripheral Arterial Disease

Guidelines recognize 4 clinical subsets of peripheral arterial disease (PAD).^1,

• Asymptomatic PAD is characterized by reporting of no leg symptoms. Patients with asymptomatic PAD may adapt their activity to avoid leg pain. Those who report no exertional leg symptoms may develop symptoms during an objective walking test. These patients have functional impairment that is comparable to those with claudication.

• Chronic symptomatic PAD (claudication) is characterized by exertional leg symptoms that can limit walking and resolve with rest. Typical claudication symptoms may be described as a pain, aching, cramping, or tired/fatigued feeling located in the buttocks, thigh, calf, or foot that occurs consistently during walking, does not start at rest, does not improve during walking, and is usually relieved within approximately 10 minutes of rest. Leg symptom descriptors also include tingling, numbness, burning, throbbing, or shooting. Chronic symptomatic PAD is associated with significant functional (walking) impairment. It is estimated that only one-third of patients with PAD present with symptoms of typical claudication, while most patients with PAD present with other exertional leg symptoms not typical of claudication. All patients with chronic symptomatic PAD, including those with atypical symptoms, have walking impairment.

• Chronic limb-threatening ischemia (CLTI) is a severe clinical subset of PAD, associated with ischemic rest pain, nonhealing wounds or ulcers, or gangrene with symptoms present longer than 2 weeks.

• Acute limb ischemia is the most severe clinical subset of PAD. It is characterized by a sudden decrease in arterial perfusion of the leg that threatens the viability of the limb. Causes of ALI include embolism, thrombosis within the native artery or at site of previous revascularization (graft or stent), trauma, peripheral aneurysm with distal embolization, or thrombosis. Severity is further classified using the Rutherford classification system (viable, salvageable/marinnally threatened, salvageable/immediately threaten, irreversible.

Prevalence and Risk Factors

Patients at risk for PAD are identified based on demographic features, cardiovascular risk factors, or the presence of atherosclerotic vascular disease in other vascular beds. Black race is associated with increased risk for PAD, even after adjustment for conventional risk factors, and is also associated with major adverse cardiovascular events (MACE) and major adverse limb events.

Screening and Diagnosis

Clinical assessment, including risk factor assessment, history, physical examination, and consideration of differential diagnoses, is performed before diagnostic testing.^2,3,

For individuals at increased risk of PAD, vascular examination with a focus on the lower extremities is recommended. After the history and physical examination identify patients at risk for PAD and with history of physical examination symptoms or signs of PAD, diagnostic testing to establish the diagnosis of PAD is performed. Diagnostic testing for suspected PAD incorporates history and physical examination, ankle-brachial index (ABI), and additional physiological testing, as well as noninvasive and potentially invasive (angiography) imaging.

Measurement of the ankle-brachial index (ABI) is the primary method for establishing the diagnosis of PAD. In patients with history or physical examination findings suggestive of PAD, the resting ABI, with or without ankle pulse volume recordings (PVR) and/or Doppler waveforms, is recommended to establish the diagnosis.

The resting ABI is reported as abnormal (< 0.90), borderline (0.91-0.99), normal (1.00-1.40), or noncompressible (>1.40). In individuals with suspected chronic symptomatic PAD and normal or borderline resting ABI, exercise ABI can be performed.

Treatment

Standard treatment for claudication includes medical therapy, foot care, and structured exercise therapy.

Percutaneous revascularization includes catheter-based revascularization procedures using modalities such as percutaneous transluminal (balloon) angioplasty, drug-coated balloon angioplasty, stenting (bare-metal, drug-coated, or covered), and atherectomy.

Revascularization, either percutaneous or surgical, is the standard treatment for CLTI.

Regulatory Status

In 2016, the Shockwave Medical Peripheral Lithotripsy (IVL) System received 510(k) clearance (K161384; FDA Product Code: PPN) for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, intrapopliteal, and renal arteries and is not for use in the coronary or cerebral vasculature. Initial clearance was based on a determination that the device was substantially equivalent to legally marketed predicate devices. The primary predicate for the Shockwave Medical Lithoplasty System is the Spectranetics, Inc. AngioSculpt PTA Scoring Balloon Catheter (K142983). Additional predicates were the Bard Peripheral Vascular VascuTrak PTA Dilatation Catheter (K103459) and the EKOS Corporation EKOS Lysus Micro-Infusion System (K060422).

Rationale

This evidence review was created in August 2024 with a search of the PubMed database. The most recent literature update was performed through August 15, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 

Percutaneous Revascularization for Chronic Symptomatic Lower Extremity Peripheral Artery Disease Using Balloon Angioplasty, Stent Procedures, or Atherectomy

Clinical Context and Therapy Purpose

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is adults with chronic symptomatic lower extremity peripheral artery disease.

Interventions

The therapy being considered is percutaneous revascularization with the following procedures:

• Balloon angioplasty;

• Drug-coated balloon angioplasty;

• Stent procedures (bare-metal, drug coated, or covered);

• Atherectomy.

Comparators

Standard treatment for chronic symptomatic PAD includes medical therapy, foot care, and structured exercise therapy.

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Wardle et al (2020) conducted a systematic review and meta-analysis of studies investigating atherectomy in individuals with symptomatic PAD.^4, The review included 7 studies (N=527; number of treated lesions=581), comparing atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. The evidence from this review was of very low certainty due to high risk of bias, imprecision, and inconsistency. The key findings indicated no clear difference between atherectomy and BA in primary patency rates at six months (RR: 1.06; 95% CI: 0.94 to 1.20; 3 studies, N=186) or at 12 months (RR: 1.20; 95% CI: 0.78 to 1.84; 2 studies, N=149), mortality rates (RR: 0.50; 95% CI: 0.10 to 2.66; 3 studies, N=210), initial technical failure rates (RR: 0.48; 95% CI: 0.22 to 1.08; 6 studies; number of treated vessels=425), and target vessel revascularization (TVR) rates at six months (RR: 0.51; 95% CI: 0.06 to 4.42; 2 studies, number of treated vessels=136) or at 12 months (RR: 0.59; 95% CI: 0.25 to 1.42; 3 studies, number of treated vessels=176). Complication rates (RR: 0.69; 95% CI: 0.28 to 1.68; 6 studies; N=387) and embolization events (RR: 2.51; 95% CI: 0.64 to 9.80; 6 studies; N=387) also showed no clear difference between atherectomy and BA. However, atherectomy may be less likely to cause dissection (RR: 0.28; 95% CI: 0.14 to 0.54; 4 studies; N=290) and may be associated with a reduction in bailout stenting (RR: 0.26; 95% CI: 0.09 to 0.74; 4 studies, number of treated vessels=315). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. Subgroup analysis comparing plain balloons/stents and drug-eluting balloons/stents did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, reporting one death (RR: 0.38; 95% CI: 0.04 to 3.23; N=155) and three complication events (RR: 7.04; 95% CI: 0.80 to 62.23; N=155), both with very low-certainty evidence. There was no clear difference in cardiovascular events (RR: 0.38; 95% CI: 0.04 to 3.23; N=155) and no initial technical failure events. TVR rates at 6 and 24 months showed little difference between treatment arms (RR: 2.27; 95% CI: 0.95 to 5.46; N=155, and RR: 2.05; 95% CI 0.96 to 4.37; N=155, respectively). The authors concluded that the evidence is very uncertain about the effect of atherectomy on patency, mortality, and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. Larger studies powered to detect clinically meaningful, patient-centered outcomes are required. A list of studies and their characteristics and the results of the meta-analyses are presented in Tables 2 to 4.

Gornik et al (2024) conducted a systematic review to support clinical practice guidelines for the management of lower extremity PAD (Refer to the Practice Guidelines and Position Statements section for detailed recommendations).^1, Given the benefits of the less invasive measures of guideline-directed management and therapy and structured exercise, revascularization is a second-tier treatment for most patients with claudication.

The reviewers concluded that revascularization (open and endovascular) has shown effectiveness in mitigation of pain with walking and improving walking distance as well as QOL although tradeoffs in durability need to be considered. The reviewers noted that most studies of revascularization for individuals with chronic symptomatic PAD enrolled participants with claudication. They noted that the potential effects of revascularization on individuals with chronic symptomatic PAD with leg symptoms other than claudication is an area in need of further study.

Guidelines recommend selection of procedures based on lesion characteristics (eg, anatomic location, lesion length, degree of calcification), operator experience, and the range of available technologies. Evaluation of the comparative effectiveness of different endovascular procedures was beyond the scope of this review.

Table 2. Comparison of Studies Included in Systematic Reviews and Meta-analyses

1 Systematic reviews / meta-analyses across the columns.2 Primary studies across the rows.

Table 3. Systematic Review and Meta-analyses Characteristics

PAD, peripheral artery disease; RCT: randomized controlled trial.1 Key eligibility criteria.

Table 4. Results of Systematic Review and Meta-analyses of Atherectomy versus Balloon Angioplasty for Peripheral Arterial Disease

CI: confidence interval; RR: risk ratio; NR: not reported.a Zeller et al (2017)6, reported cardiac failure and acute coronary syndrome as causes of death at 24 months, but it was unclear for which participants in which arms this was accountable for. Shammas et al (2011)9, declared embolic stroke and myocardial infarction to be secondary outcomes, but no events were recorded in either arm.

Section Summary: Percutaneous Revascularization Procedures for Chronic Symptomatic Lower Extremity Peripheral Artery Disease

A systematic review of randomized controlled trials has demonstrated that percutaneous and surgical revascularization for chronic symptomatic PAD can improve symptoms and quality of life in individuals who have not responded to guideline directed medical treatment, including structured exercise. Guidelines recommend that the choice to proceed to revascularization and selection of procedure should be a shared decision-making process, based on clinical presentation, including severity of symptoms and anticipated natural history; degree of functional limitation and QOL impairment; response to medical therapy, including structured exercise; and the likelihood of a beneficial short- and longer-term outcome, balanced against potential short-term (eg, bleeding, infection, MACE) and longer-term procedural risk.

For individuals who are adults with symptomatic lower extremity peripheral arterial disease who receive percutaneous revascularization with balloon angioplasty, stent procedures, or atherectomy, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. Multiple studies have demonstrated that percutaneous and surgical revascularization for chronic symptomatic PAD can improve symptoms and quality of life in individuals who have not responded to guideline directed medical treatment, including structured exercise. Guidelines recommend that the choice to proceed to revascularization and selection of procedure should be a shared decision-making process, based on clinical presentation, including severity of symptoms and anticipated natural history; degree of functional limitation and QOL impairment; response to medical therapy, including structured exercise; and the likelihood of a beneficial short- and longer-term outcome, balanced against potential short-term (eg, bleeding, infection, major adverse cardiac events), and longer-term procedural risk. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 2

Percutaneous Revascularization Procedures for Chronic Limb Threatening Ischemia Using Balloon Angioplasty, Stent Procedures, or Atherectomy

Clinical Context and Therapy Purpose

The purpose of percutaneous revascularization in individuals who have chronic limb-threatening ischemia (CLTI) is to promote wound healing and prevent limb amputation.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest are adults with CLTI.

Interventions

The therapy being considered is percutaneous revascularization with the following procedures:

• Balloon angioplasty;

• Stent procedure;

• Atherectomy.

Comparators

Revascularization is considered the standard treatment for patients with CLTI to minimize tissue loss and preserve a functional limb and ambulatory status. Therapies for wound care, management of infection, and pressure offloading are important adjunctive components of care for CLTI in addition to revascularization.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

Abouzid et al (2024) conducted a systematic review and meta-analysis comparing endovascular therapy and surgical revascularization for CLTI^12, The analysis included 16 studies (N=47,609). The results showed that surgery is associated with a lower risk of major adverse limb events (MALE) (odds ratio (OR): 1.13; 95% CI: 1.01 to 1.28, P:.04), while endovascular therapy is linked to lower rates of major adverse cardiovascular events (MACE) (OR: 0.62; 95% CI: 0.51 to 0.76; P<.00001), bleeding, wound complications, readmission, unplanned reoperation, acute renal failure, and shorter hospital stays. There was no significant difference in 30-day mortality between the two groups (OR: 0.94; 95% CI: 0.79 to 1.12; P=.52). The authors conclude the results suggest that the choice between endovascular therapy and surgery should be based on a multidisciplinary team approach, considering patient characteristics and anatomy. A list of studies and their characteristics and the results of the meta-analyses are presented in Table 5 to 7.

In 2024 the American College of Cardiology/American Heart Association Joint Committee conducted a systematic review to inform clinical practice guidelines, citing the BEST-CLI (Best Endovascular versus Best Surgical Therapy in Patients with CLI) and BASIL-2 (Bypass versus Angioplasty for Severe Ischaemia of the Leg) trials as further informing revascularization strategy in patients with CLTI.^1,13,14, The contrasting findings of the BEST-CLI and BASIL-2 trials highlight the need to consider patient clinical and anatomic characteristics when selecting the initial revascularization strategy for patients with CLTI, including consideration of patient risk estimation, staging of the limb for severity and anatomic pattern of disease, previous vascular interventions, and availability of conduit.

The guidelines additionally cite a systematic review of 13 studies looking at the natural history of patients with CLTI enrolled in medical and angiogenic therapy trials who did not receive revascularization in which a 22% all-cause mortality rate and a 22% rate of major amputation at a median follow-up of 12 months were observed.^15, Thus, all patients with CLTI should undergo assessment for revascularization. Data from RCTs and observational evidence inform revascularization strategy in CLTI. Both endovascular and surgical revascularization have been demonstrated to be effective treatments for preventing amputation in CLTI.

Table 5. Comparison of Studies Included in Systematic Reviews and Meta-analyses

Table 6. Systematic Review and Meta-analyses Characteristics

CLTI: chronic limb-threatening ischemia; NR: not reported; RCT: randomized controlled trial.1 Key eligibility criteria.

Table 7. Results of Systematic Review and Meta-analyses of Surgical Intervention versus Endovascular Technique

CI: confidence interval; OR: odds ratio.1 If the M-A includes a quantitative synthesis then include numbers analyzed, measures of effect (absolute or relative) with CI and measure of heterogeneity. If the M-A includes only a qualitative synthesis then include the ranges of N and effects.

Randomized Controlled Trials

Bradbury et al (2023) conducted the BASIL-2 trial (N=345) comparing the effectiveness of vein bypass versus best endovascular treatment for patients with CLTI requiring infra-popliteal revascularization.^14, The trial was conducted at 41 vascular surgery sites in the UK, Sweden, and Denmark, and followed participants for a minimum of 2 years. The primary outcome was amputation-free survival, defined as the time to the first major amputation above the ankle or death from any cause, using the intention-to-treat population. Results showed that major amputation or death occurred in 63% of the vein bypass group compared to 53% of the best endovascular treatment group (adjusted hazard ratio (HR): 1.35; 95% CI: 1.02 to 1.80; p=.037). Additionally, 53% of the vein bypass group and 45% of the best endovascular treatment group died (adjusted HR: 1.37; 95% CI: 1.00 to 1.87). The authors concluded that a best endovascular treatment first revascularization strategy was associated with better amputation-free survival, suggesting that more patients with CLTI should be considered for this approach. A limitation of the trial was that the planned enrollment was not met due to recruitment challenges.

Farber et al (2022) conducted the BEST-CLI trial (N=1830) investigating the effectiveness of endovascular therapy versus surgical revascularization for patients with CLTI.^13, Cohort 1 included patients with an adequate single segment of great saphenous vein that could be used for surgery. In Cohort 1, the incidence of major adverse limb events or death was significantly lower in the surgical group compared to the endovascular group (42.6% vs 57.4%; HR: 0.68; 95% CI: 0.59 to 0.79; P<.001). Cohort 2 included patients who needed an alternative bypass conduit. In Cohort 2, the outcomes were similar between the surgical group and the endovascular group (42.8% vs 47.7%; HR: 0.79; 95% CI: 0.58 to 1.06; P=.12). The incidence of adverse events was similar in both groups across the two cohorts. A limitation of this study was selection bias because participant eligibility was determined locally and varied by site.

A summary of RCT characteristics and results are presented in Tables 8 and 9. Study relevance, and design and conduct limitations are presented in Tables 10 and 11.

Table 8. Summary of Key RCT Characteristics

CLTI: chronic limb-threatening ischemia; RCT: randomized controlled trial.1 Number randomized; intervention; mode of delivery; dose (frequency/duration).2 Key eligibility criteria

Table 9. Summary of Key RCT Results

CI: confidence interval; HR: hazard ratio; NR: not reported.1 Include number analyzed, effect in each group, and measure of effect (absolute or relative) with CI,2 Describe the range of sample sizes, effects, and other notable features in text.

Table 10. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 11. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Nonrandomized Studies

Nugteren et al (2023) conducted a retrospective analysis of prospectively collected data from 29 consecutive participants with CLTI who were enrolled in the Disrupt PAD III Trial.^31, All consecutive patients treated with lithotripsy at 4 Dutch hospitals were included. The primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. The primary safety endpoint was the freedom from a composite of major adverse events (MAEs) through 30 days, defined as abrupt closure, distal embolization, perforation, emergency revascularization, major amputation, and death. The primary patency, limb salvage, and AFS for CLTI patients were 68.8%, 83.9%, and 57.1% at 12 months, respectively. During follow-up, 3 major amputations were performed due to progressive foot ulceration without infection, all within 3 months of intervention. A total of 5 patients died, whose causes of death were acute coronary syndrome (ACS), acute mesenteric ischemia, and in 3 patients a palliative course, including 1 due to progressive foot ulceration. he rate of MAE at 30 days was 13.3%. In 1 patient, the closure device failed and led to an acute occlusion, after which a femoral endarterectomy was performed to remove the closure device. Another patient was amputated after 16 days due to progressive foot ulceration. Two patients died within 30 days after the intervention because of an ACS and a palliative course due to treatment-requiring multi-morbidity and lack of perspective. The study was limited by a low sample size, heterogeneity in post-dilatation technique, lack of a control group, and lack of an independent core laboratory adjudication.

Section Summary: Percutaneous Revascularization Procedures for Chronic Limb Threatening Ischemia Using Balloon Angioplasty, Stent Procedures, or Atherectomy

Randomized controlled trials (RCT), observational studies, and a systematic review of RCTs and observational studies have demonstrated both endovascular and surgical revascularization have been demonstrated to be effective treatments for preventing amputation in CLTI. The RCTs, the BEST-CLI and BASIL-2 trials, had contrasting results highlighting the need to consider patient clinical and anatomic characteristics when selecting the initial revascularization strategy for patients with CLTI, including consideration of patient risk estimation, staging of the limb for severity and anatomic pattern of disease, previous vascular interventions, and availability of conduit. In a systematic review of 13 studies of patients with CLTI enrolled in medical and angiogenic therapy trials who did not receive revascularization, a 22% all-cause mortality rate and a 22% rate of major amputation at a median follow-up of 12 months were observed.

For individuals who are adults with chronic limb-threatening ischemia (CLTI) who receive percutaneous revascularization with balloon angioplasty, stent procedures, or atherectomy, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. Revascularization is considered the standard treatment for patients with CLTI to minimize tissue loss and preserve a functional limb and ambulatory status. Both endovascular and surgical revascularization have been demonstrated to be effective treatments for preventing amputation in CLTI. In a systematic review of 13 studies of patients with CLTI enrolled in medical and angiogenic therapy trials who did not receive revascularization, a 22% all-cause mortality rate and a 22% rate of major amputation at a median follow-up of 12 months were observed. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 3 

Percutaneous Revascularization Procedures for Acute Limb Ischemia Using Balloon Angioplasty, Stent Procedures, or Atherectomy

Clinical Context and Therapy Purpose

The purpose of percutaneous revascularization in individuals who have acute limb ischemia is to prevent irreversible tissue damage and major amputation.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest are adults with acute limb ischemia.

Interventions

The therapy being considered is percutaneous revascularization with the following procedures:

• Balloon angioplasty

• Stent procedure

• Atherectomy

Comparators

Standard medical treatment for acute limb ischemia includes medications, exercise therapy,

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Veenstra et al (2020) conducted a systematic review and meta-analysis on the safety and effectiveness of surgical revascularization versus catheter-driven thrombolysis (CDT) for treating acute limb ischemia.^32, A meta-analysis of 25 studies (N=4689) found no significant differences in limb salvage between thrombectomy and thrombolysis. However, thrombolysis was associated with a higher incidence of major vascular events compared to surgical treatment, (6.5% vs 4.4%; odds ratio (OR): 0.33; 95% CI: 0.13 to 0.87; P=.02; I²=20%). Both CDT and surgery have comparable limb salvage rates, but CDT carries a higher risk of hemorrhagic complications. There was a lack of randomized controlled trials and future trials should ensure comparable study groups and standardized outcome reporting practices. A list of studies and their characteristics and the results of the meta-analyses are presented in Tables 12 to 14.

Table 12. Comparison of Studies Included in Systematic Reviews and Meta-analyses

Table 13. Systematic Review and Meta-analyses Characteristics

RCT: randomized controlled trial.1 Key eligibility criteria.

Table 14. Results of Systematic Review and Meta-analyses of Surgical Revascularization versus Catheter-driven Thrombolysis

CI: confidence interval; OR: odds ratio.1 If the M-A includes a quantitative synthesis then include numbers analyzed, measures of effect (absolute or relative) with CI and measure of heterogeneity. If the M-A includes only a qualitative synthesis then include the ranges of N and effects.

Section Summary: Percutaneous Revascularization Procedures for Acute Limb Ischemia Using Balloon Angioplasty, Stent Procedures, or Atherectomy

A systematic review consisting of randomized controlled trials and observational studies demonstrated surgical revascularization is an effective treatment in patients with acute limb ischemia. Thrombolysis was associated with a higher incidence of major vascular events compared to surgical treatment, (6.5% vs 4.4%). Both thrombolysis and surgery have comparable limb salvage rates, but CDT carries a higher risk of hemorrhagic complications.

For individuals who are adults with acute limb ischemia who receive percutaneous revascularization with balloon angioplasty, stent procedures, or atherectomy, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. A systematic review consisting of randomized controlled trials and observational studies demonstrated surgical revascularization is an effective treatment in patients with acute limb ischemia. Thrombolysis was associated with a higher incidence of major vascular events compared to surgical treatment (6.5% vs 4.4%). Both thrombolysis and surgery have comparable limb salvage rates, but thrombolysis carries a higher risk of hemorrhagic complications. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 4

Percutaneous Revascularization for Lower Extremity Peripheral Artery Disease Using Lithotripsy

Clinical Context and Therapy Purpose

Percutaneous revascularization for lower extremity PAD using lithotripsy is proposed as a vessel preparation option to facilitate definitive endovascular treatment in heavily calcified lesions.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is adults with lower extremity peripheral artery disease.

Interventions

The therapy being considered is percutaneous revascularization with lithotripsy. Lithotripsy uses multiple emitters mounted on a traditional angioplasty balloon catheter that provide pulsatile acoustic pressure energy to fracture superficial and deep calcium without affecting local soft tissues or liberating emboli.

Comparators

Standard care for peripheral artery disease includes smoking cessation, pharmacotherapy (antiplatelets, statins), and exercise.

Outcomes

The outcomes of interest are procedural success, patency, and safety outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Randomized Controlled Trial

Lithotripsy using the Shockwave system has been evaluated in 1 RCT, known as the Disrupt PAD III Trial (NCT02923193).^43, The trial compared vessel preparation with lithotripsy versus percutaneous transluminal angioplasty prior to drug-coated balloon in 306 individuals with symptomatic PAD (Table 15). The primary endpoint was core-lab adjudicated procedural success. Secondary outcomes, evaluated at 30 days, included clinically driven target lesion revascularization, change in ABI, change in Rutherford class, health utility based on response to the EQ-5D questionnaire, and walking capacity on the Walking Impairment Questionnaire. Major adverse events assessed included unplanned surgical revascularization or major amputation (above ankle) of the target limb, symptomatic thrombus or embolus requiring treatment, and perforations requiring provisional stent placement or other treatment. The powered secondary endpoint was primary patency at 12 months, reported in a subsequent publication.^44,

Procedural success was achieved in 65.8% of individuals in the lithotripsy group, compared to 54.0% in the control group (P=.01).^43, Tepe et al (2022) reported primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization (CD-TLR) plus freedom from restenosis determined by duplex ultrasound (Table 16).^44, Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency. Primary patency at 1 year was superior in the lithotripsy group compared to the control group (80.5% vs 68.0%, P=.017). The difference was driven by the freedom from provisional stent placement rate; freedom from the individual endpoints of CD-TLR and restenosis at 1 year were similar between the 2 groups. The MAE rate at 12 months was similar in both groups. Both groups demonstrated improvement in ABI index, WIQ, EQ-5D, and Rutherford category, but there were no differences in the change from baseline to 1 year between treatment groups.

A summary of study characteristics and results are presented in Tables 15 and 16. Study relevance, and design and conduct limitations are presented in Tables 17 and 18. A major limitation of the study was a lack of comparison to other percutaneous revascularization procedures.

Table 15. Summary of Key RCT Characteristics

EQ-5D: EuroQol-5 Dimension.

Table 16. Summary of Key RCT Results

 PTA: percutaneous transluminal angioplasty.

Table 17. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 18. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Nonrandomized Studies

A number of nonrandomized studies have reported outcomes in consecutive patients undergoing lithotripsy for chronic symptomatic PAD or CLTI. These studies are limited by lack of a control group, small sample sizes, and heterogeneity in clinical and procedural characteristics.^45,46,

Section Summary: Percutaneous Revascularization for Lower Extremity Peripheral Artery Disease Using Lithotripsy

One randomized controlled trial (RCT) and nonrandomized studies have been conducted on symptomatic lower extremity PAD who receive percutaneous revascularization. The RCT demonstrated primary patency at 1 year was superior in the lithotripsy group compared to the control group (80.5% vs 68.0%, P=.017). A major limitation of the study was a lack of comparison to other percutaneous revascularization procedures. The nonrandomized studies are limited by their lack of a control group, small sample sizes, and heterogeneity in clinical and procedural characteristics. 

For individuals who are adults with symptomatic lower extremity peripheral arterial disease (PAD) who receive percutaneous revascularization using lithotripsy, the evidence includes 1 RCT and nonrandomized studies. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. The RCT demonstrated primary patency at 1 year was superior in the lithotripsy group compared to the control group (80.5% vs 68.0%, P=.017). A major limitation of the study was a lack of comparison to other percutaneous revascularization procedures. The nonrandomized studies are limited by their lack of a control group, small sample sizes, and heterogeneity in clinical and procedural characteristics. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 5 

Percutaneous Revascularization Procedures for Asymptomatic Lower Extremity Peripheral Artery Disease

Clinical Context and Therapy Purpose

The purpose of percutaneous revascularization in individuals who have asymptomatic lower extremity peripheral artery disease would be to prevent progression to symptomatic disease.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is adults with asymptomatic lower extremity peripheral artery disease.

Interventions

The therapy being considered is percutaneous revascularization with any of the following procedures:

• Balloon angioplasty

• Stent procedure

• Atherectomy

• Lithotripsy

Comparators

Standard care for asymptomatic peripheral artery disease includes smoking cessation, pharmacotherapy (antiplatelets, statins), and exercise.

Outcomes

The outcomes of interest are progression to symptomatic PAD and procedure-related adverse events, including the need for revascularization.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

A systematic review conducted to support a the ACC/AHA guideline for the management of lower extremity PAD identified no evidence that invasive treatment while PAD is asymptomatic will alter its natural history, and evidence showing that individuals who have undergone a revascularization procedure are at increased risk of subsequent complications, particularly MALE, including the need for additional subsequent revascularization procedures.^1, The reviewers concluded that no evidence supports a recommendation for early revascularizaton for asymptomatic individuals.

Section Summary: Percutaneous Revascularization Procedures for Asymptomatic Lower Extremity Peripheral Artery Disease

Although some individuals with asymptomatic PAD will progress to symptomatic disease, there is no evidence that performing early invasive revascularization procedures leads to a reduction in the development of symptomatic disease. Further, there is evidence that undergone a revascularization procedure are at increased risk of subsequent complications, including the need for additional subsequent revascularization procedures. Therefore, the risks of the procedure do not outweigh any proposed benefits.

For individuals who are adults with asymptomatic lower extremity peripheral arterial disease (PAD) who receive percutaneous revascularization using any procedure, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, morbid events, functional outcomes, and treatment-related mortality and morbidity. Although some individuals with asymptomatic PAD will progress to symptomatic disease, there is no evidence that performing early invasive revascularization procedures leads to a reduction in the development of symptomatic disease. Further, there is evidence that undergone a revascularization procedure are at increased risk of subsequent complications, including the need for additional subsequent revascularization procedures. Therefore, the risks of the procedure do not outweigh any proposed benefits. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Cardiology/American Heart Association, 2024

In 2024, the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines published a Guideline for the Management of Lower Extremity PAD.^1, The Guideline was developed in collaboration with and endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, American Podiatric Medical Association, Association of Black Cardiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, Society of Interventional Radiology, and Vascular & Endovascular Surgery Society. The Guideline included the following statements relevant to this evidence review (Tables 19 and 20):

Table 19. Revascularization for Asymptomatic Peripheral Artery Disease

Table 20. Revascularization for Claudication (Chronic Symptomatic Peripheral Artery Disease)

The Guideline states that "The appropriateness of particular endovascular therapies for the treatment of claudication is beyond the scope of this document but has been addressed in other multisocietal statements" and cites the statements detailed below.

American College of Cardiology, et al (2018)

In 2018, the American College of Cardiology, American Heart Association/Society for Cardiovascular Angiography and Intervention, Society of Interventional Radiology, and Society for Vascular Medicine published Appropriate Use Criteria for Peripheral Artery Intervention.^47, Appropriate use scores for endovascular treatment of relevant indications are shown in Table 21.

Table 21. Appropriate Use Criteria for Peripheral Artery Intervention

The document also includes appropriateness criteria for choice of endovascular procedure (atherectomy, balloon angioplasty, or stent) for different clinical situations, but does not mention lithotripsy.

Society for Interventional Radiology

In 2020, the Society for Interventional Radiology published guidelines on device selection in aorto-iliac arterial interventions.^48, The guidelines provide recommendations for the use of balloon angioplasty, stent procedures, and atherectomy in different clinical situations. Although specific guidelines for lithotripsy are not mentioned, the document mentions lithotripsy under the "Adjunctive Therapies" section and note that long-term data is needed.

Society for Vascular Surgery

In 2015, the Society for Vascular Surgery published guidelines for the management of asymptomatic PAD and intermittent claudication.^2, Relevant recommendations are summarized below.

Asymptomatic Peripheral Artery Disease

3.1. We recommend multidisciplinary comprehensive smoking cessation interventions for patients with asymptomatic PAD who use tobacco (repeatedly until tobacco use has stopped). 1 A
3.2. We recommend providing education about the signs and symptoms of PAD progression to asymptomatic patients with PAD. 1 Ungraded
3.3. We recommend against invasive treatments for PAD in the absence of symptoms, regardless of hemodynamic measures or imaging findings demonstrating PAD. 1 B

Intermittent Claudication- Invasive Treatments

5.1. We recommend endovascular therapy or surgical treatment of IC for patients with significant functional or lifestyle-limiting disability when there is a reasonable likelihood of symptomatic improvement with treatment, when pharmacologic or exercise therapy, or both, have failed, and when the benefits of treatment outweigh the potential risks.
1 B
5.2. We recommend an individualized approach to select an invasive treatment for IC. The modality offered should provide a reasonable likelihood of sustained benefit to the patient (>50% likelihood of clinical efficacy for at least 2 years). For revascularization, anatomic patency (freedom from hemodynamically significant restenosis) is considered a prerequisite for sustained efficacy.

In 2022, the Society published Appropriate Use Criteria for Management of Intermittent Claudication.^49, Revascularization was rated as B>R (benefit outweighs risk) for selected patients with severe lifestyle-limiting intermittent claudication symptoms despite treatment with optimal medical therapy and an adequate trial of exercise. The panel noted, "specific types of endovascular interventions (eg, angioplasty, stenting, atherectomy) were not included in these AUC owing to the large number of additional scenarios that would be required. Furthermore, the amount and quality of data available regarding the outcomes of interventions for multilevel disease and specific types of endovascular interventions are limited. Thus, if included, the ratings would have relied primarily on expert opinion." Lithotripsy was not mentioned in the document.

U.S. Preventive Services Task Force Recommendations

in 2018, the USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for PAD and cardiovascular disease risk with the ankle-brachial index (ABI) in asymptomatic adults.

Medicare National Coverage

There is no national coverage determination for percutaneous revascularization procedures for PAD. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 22.

Table 22. Summary of Key Trials

NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.

References

1. Gornik HL, Aronow HD, Goodney PP, et al. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Jun 11 2024; 149(24): e1313-e1410. PMID 38743805
2. Conte MS, Pomposelli FB, Clair DG, et al. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. J Vasc Surg. Mar 2015; 61(3 Suppl): 2S-41S. PMID 25638515
3. Criqui MH, Matsushita K, Aboyans V, et al. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. Aug 31 2021; 144(9): e171-e191. PMID 34315230
4. Wardle BG, Ambler GK, Radwan RW, et al. Atherectomy for peripheral arterial disease. Cochrane Database Syst Rev. Sep 29 2020; 9(9): CD006680. PMID 32990327
5. Ott I, Cassese S, Groha P, et al. Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH). Circulation. Jun 06 2017; 135(23): 2218-2226. PMID 28424222
6. Zeller T, Langhoff R, Rocha-Singh KJ, et al. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. Sep 2017; 10(9): e004848. PMID 28916599
7. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. Aug 2014; 26(8): 355-60. PMID 25091093
8. Shammas NW, Lam R, Mustapha J, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. Aug 2012; 19(4): 480-8. PMID 22891826
9. Shammas NW, Coiner D, Shammas GA, et al. Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial. J Vasc Interv Radiol. Sep 2011; 22(9): 1223-8. PMID 21757372
10. Nakamura S, Conroy RM, Gordon IL, et al. A randomized trial of transcutaneous extraction atherectomy in femoral arteries: intravascular ultrasound observations. J Clin Ultrasound. Oct 1995; 23(8): 461-71. PMID 7499516
11. Vroegindeweij D, Tielbeek AV, Buth J, et al. Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: two-year follow-up with color-flow duplex scanning. J Vasc Surg. Feb 1995; 21(2): 255-68; discussion 268-9. PMID 7853599
12. Abouzid MR, Vyas A, Kamel I, et al. Comparing the efficacy and safety of endovascular therapy versus surgical revascularization for critical limb-threatening ischemia: A systematic review and Meta-analysis. Prog Cardiovasc Dis. Jul 07 2024. PMID 38981532
13. Farber A, Menard MT, Conte MS, et al. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. Dec 22 2022; 387(25): 2305-2316. PMID 36342173
14. Bradbury AW, Moakes CA, Popplewell M, et al. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. May 27 2023; 401(10390): 1798-1809. PMID 37116524
15. Abu Dabrh AM, Steffen MW, Undavalli C, et al. The natural history of untreated severe or critical limb ischemia. J Vasc Surg. Dec 2015; 62(6): 1642-51.e3. PMID 26391460
16. Kim TI, Zhang Y, Cardella JA, et al. Outcomes of bypass and endovascular interventions for advanced femoropopliteal disease in patients with premature peripheral artery disease. J Vasc Surg. Dec 2021; 74(6): 1968-1977.e3. PMID 34090986
17. Latz CA, Boitano L, Wang LJ, et al. Contemporary Endovascular 30-Day Outcomes for Critical Limb Threatening Ischemia Relative to Surgical Bypass Grafting. Vasc Endovascular Surg. Jul 2021; 55(5): 441-447. PMID 33602047
18. Lee KB, Macsata RA, Lala S, et al. Outcomes of open and endovascular interventions in patients with chronic limb threatening ischemia. Vascular. Oct 2021; 29(5): 693-703. PMID 33190618
19. Lawaetz M, Fisker L, Lönn L, et al. In Situ Vein Bypass Is Superior to Endovascular Treatment of Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia. Ann Vasc Surg. Aug 2020; 67: 437-447. PMID 32234573
20. Stavroulakis K, Gkremoutis A, Borowski M, et al. Bypass Grafting vs Endovascular Therapy in Patients With Non-Dialysis-Dependent Chronic Kidney Disease and Chronic Limb-Threatening Ischemia (CRITISCH Registry). J Endovasc Ther. Aug 2020; 27(4): 599-607. PMID 32633651
21. Altreuther M, Mattsson E. Long-Term Limb Salvage and Amputation-Free Survival After Femoropopliteal Bypass and Femoropopliteal PTA for Critical Ischemia in a Clinical Cohort. Vasc Endovascular Surg. Feb 2019; 53(2): 112-117. PMID 30803415
22. Dayama A, Tsilimparis N, Kolakowski S, et al. Clinical outcomes of bypass-first versus endovascular-first strategy in patients with chronic limb-threatening ischemia due to infrageniculate arterial disease. J Vasc Surg. Jan 2019; 69(1): 156-163.e1. PMID 30579443
23. Bodewes TCF, Darling JD, Deery SE, et al. Patient selection and perioperative outcomes of bypass and endovascular intervention as first revascularization strategy for infrainguinal arterial disease. J Vasc Surg. Jan 2018; 67(1): 206-216.e2. PMID 28844467
24. Fashandi AZ, Mehaffey JH, Hawkins RB, et al. Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication. J Vasc Surg. Dec 2018; 68(6): 1817-1823. PMID 30470369
25. Shannon AH, Mehaffey JH, Cullen JM, et al. A Comparison of Outcomes After Lower Extremity Bypass and Repeat Endovascular Intervention Following Failed Previous Endovascular Intervention for Critical Limb Ischemia. Angiology. Jul 2019; 70(6): 501-505. PMID 30376723
26. Veraldi GF, Mezzetto L, Macrì M, et al. Comparison of Endovascular Versus Bypass Surgery in Femoropopliteal TASC II D Lesions: A Single-Center Study. Ann Vasc Surg. Feb 2018; 47: 179-187. PMID 28943491
27. Darling JD, McCallum JC, Soden PA, et al. Results for primary bypass versus primary angioplasty/stent for lower extremity chronic limb-threatening ischemia. J Vasc Surg. Aug 2017; 66(2): 466-475. PMID 28274753
28. Mehaffey JH, Hawkins RB, Fashandi A, et al. Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention. J Vasc Surg. Oct 2017; 66(4): 1109-1116.e1. PMID 28655549
29. Siracuse JJ, Menard MT, Eslami MH, et al. Comparison of open and endovascular treatment of patients with critical limb ischemia in the Vascular Quality Initiative. J Vasc Surg. Apr 2016; 63(4): 958-65.e1. PMID 26830690
30. McQuade K, Gable D, Pearl G, et al. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. Sep 2010; 52(3): 584-90; discussion 590-1, 591.e1-591.e7. PMID 20598480
31. Nugteren MJ, Hazenberg CEVB, Akkersdijk GP, et al. Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia. J Endovasc Ther. Oct 18 2023: 15266028231205421. PMID 37853746
32. Veenstra EB, van der Laan MJ, Zeebregts CJ, et al. A systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. Feb 2020; 71(2): 654-668.e3. PMID 31353270
33. Taha AG, Byrne RM, Avgerinos ED, et al. Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg. Jan 2015; 61(1): 147-54. PMID 25080883
34. de Donato G, Setacci F, Sirignano P, et al. The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. J Vasc Surg. Mar 2014; 59(3): 729-36. PMID 24342067
35. Ouriel K, Veith FJ, Sasahara AA. A comparison of recombinant urokinase with vascular surgery as initial treatment for acute arterial occlusion of the legs. Thrombolysis or Peripheral Arterial Surgery (TOPAS) Investigators. N Engl J Med. Apr 16 1998; 338(16): 1105-11. PMID 9545358
36. Ouriel K, Veith FJ, Sasahara AA. Thrombolysis or peripheral arterial surgery: phase I results. TOPAS Investigators. J Vasc Surg. Jan 1996; 23(1): 64-73; discussion 74-5. PMID 8558744
37. Hoch JR, Tullis MJ, Acher CW, et al. Thrombolysis versus surgery as the initial management for native artery occlusion: efficacy, safety, and cost. Surgery. Oct 1994; 116(4): 649-56; discussion 656-7. PMID 7940162
38. Ouriel K, Shortell CK, DeWeese JA, et al. A comparison of thrombolytic therapy with operative revascularization in the initial treatment of acute peripheral arterial ischemia. J Vasc Surg. Jun 1994; 19(6): 1021-30. PMID 8201703
39. Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. The STILE trial. Ann Surg. Sep 1994; 220(3): 251-66; discussion 266-8. PMID 8092895
40. Nilsson L, Albrechtsson U, Jonung T, et al. Surgical treatment versus thrombolysis in acute arterial occlusion: a randomised controlled study. Eur J Vasc Surg. Mar 1992; 6(2): 189-93. PMID 1572460
41. Earnshaw JJ, Gregson RH, Makin GS, et al. Acute peripheral arterial ischemia: a prospective evaluation of differential management with surgery or thrombolysis. Ann Vasc Surg. Oct 1989; 3(4): 374-9. PMID 2512979
42. Seeger JM, Flynn TC, Quintessenza JA. Intra-arterial streptokinase in the treatment of acute arterial thrombosis. Surg Gynecol Obstet. Apr 1987; 164(4): 303-7. PMID 3563841
43. Tepe G, Brodmann M, Werner M, et al. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. Jun 28 2021; 14(12): 1352-1361. PMID 34167675
44. Tepe G, Brodmann M, Bachinsky W, et al. Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial. J Soc Cardiovasc Angiogr Interv. 2022; 1(4): 100341. PMID 39131928
45. Adams G, Soukas PA, Mehrle A, et al. Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study. J Endovasc Ther. Feb 2022; 29(1): 76-83. PMID 34380334
46. Shammas NW, Mangalmurti S, Bernardo NL, et al. Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study. J Endovasc Ther. Jun 15 2024: 15266028241255622. PMID 38877777
47. Bailey SR, Beckman JA, Dao TD, et al. ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine. J Am Coll Cardiol. Jan 22 2019; 73(2): 214-237. PMID 30573393
48. Feldman DN, Armstrong EJ, Aronow HD, et al. SCAI guidelines on device selection in Aorto-Iliac arterial interventions. Catheter Cardiovasc Interv. Oct 01 2020; 96(4): 915-929. PMID 32406565
49. Woo K, Siracuse JJ, Klingbeil K, et al. Society for Vascular Surgery appropriate use criteria for management of intermittent claudication. J Vasc Surg. Jul 2022; 76(1): 3-22.e1. PMID 35470016

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