Missing a step? Searching for meaning in claudication research

A team of leading vascular surgeons in the care of patients with PAD weigh up evidence for the treatment of claudication, calling for research focused on clarifying who should be revascularized, and who should continue with medical management and exercise therapy.

Intermittent claudication (IC) is the most common symptomatic manifestation of lower extremity peripheral arterial disease (PAD). Despite its prevalence, IC remains a condition more often overtreated than understood.

The natural history of IC is generally benign, with major amputation risk less than 1% per year; the risk of death from cardiovascular causes is substantially higher than the risk of limb loss.¹ As such, first-line management, as outlined in the SVS appropriate use criteria (AUC) and clinical practice guidelines (CPG) is education, optimal medical therapy (OMT) and structured exercise therapy.^2,3 Despite this, patients and providers are often focused on modest leg symptoms and unsubstantiated fears of limb loss, rather than reducing risks of cardiovascular morbidity or acknowledging limited long-term benefit of IC interventions.

Enthusiasm for revascularization in IC often arises from a genuine desire to improve patient disability. There are patients for whom revascularization can deliver meaningful symptomatic improvement; the challenge lies in identifying those individuals and providing counseling on the risks and benefits, amid a limited evidence base. Accurately predicting the magnitude and durability of improvement for each patient experiencing IC is central to informed decision-making—yet the data needed to support these everyday clinical discussions remain shockingly sparse.

Evidence from randomized controlled trials (RCTs) and cohort studies consistently shows that invasive treatments for IC offer, at best, short-term improvements in walking performance without sustained quality-of-life (QoL) advantage over exercise or OMT. Few RCTs exist that compare management strategies, and those that have been executed are modest in size and scope. In addition, studies show that many endovascular interventions for IC fail to meet minimum efficacy standards, while risks of reintervention and disease progression increase over time.^4,5 Selecting patients most likely to benefit from revascularization therefore requires both time and nuance, and a willingness to acknowledge the limitations of current evidence and prioritize shared decision-making, grounded in realistic expectations.

While this background would suggest that a minority of IC patients would benefit from revascularization, the numbers tell another story. Medicare‐allowed charges for IC have increased by roughly $12 million per year between 2011 and 2022,⁶ indicating that revascularization for IC is on the rise. This observation has not escaped public attention, with the New York Times and ProPublica both having published investigative reports chronicling the rapid expansion and questionable practices of outpatient vascular care.^7–11 The ability to provide less invasive endovascular interventions in ambulatory settings, with low procedural risk, has understandably driven the market growth. How do we ensure that patients and physicians receive the best information for these treatment decisions?

The 2024 SVS CPG update on the management of IC identified seven major research gaps, the top three concerning the role of revascularization.² A PubMed search yields over 175 IC-related publications in 2025 alone, yet quantity has not translated to quality in IC research. In the absence of prospective trials, numerous researchers have conducted retrospective analyses using various sources of observational data, such as procedural registries and administrative datasets. This approach limits study design to available datapoints, rather than the appropriate ones. It can lead to posing questions that the data were never designed, or equipped, to properly answer. A recent example exhibiting this fundamental flaw was published in JAMA Network Open, a journal with an impact factor of 9.7, wherein the authors used major amputation as the primary endpoint for a comparison between open and endovascular revascularization strategies for IC.¹²

The primary endpoint for a comparative effectiveness study should be directly related to the intervention’s purpose. Meaningful outcomes in IC should focus on patient priorities of walking performance, symptom relief and health-related QoL. Using major amputation as a primary endpoint for comparative effectiveness studies in IC implies that amputation prevention is the treatment goal in IC, which is a dangerous false flag. It is a safety endpoint, not an efficacy endpoint. While risks of limb loss and mortality are expected to be low, recurrent symptoms, repeat procedures and potential hastening of disease progression to chronic limb-threatening ischemia (CLTI) are common adverse outcomes that should be ascertained in any study of invasive treatment for IC.

High-quality studies derived from large databases leverage the statistical benefits of sample size but interpret findings in the context of clinical relevance. In the referenced study, the authors reported one-year amputation rates of 0.6% and 0.9% for endovascular and open surgery, respectively, focusing on the statistically significant but clinically meaningless difference in what are, quite thankfully, acceptably low rates of a catastrophic outcome. The study’s conclusion—that “patients with claudication may benefit most from endovascular-first intervention and subsequent open bypass using reversed GSV [great saphenous vein] conduit”—reads as a troubling endorsement of endovascular overuse at risk for being taken out of context. The study design’s inappropriate emphasis on amputation risk rather than patient-centered outcomes for IC or adherence to the SVS AUC for IC perpetuates fear-driven treatment patterns that may lead to harm. In addition, there was a missed opportunity to underscore the alarming finding that 13.2% of patients in the study underwent tibial endovascular interventions for IC, a practice deemed to universally carry more risk than benefit by the SVS AUC.³

As noted above, research using any large administrative and/or procedural database (e.g., Medicare, the American College of Surgeons [ACS] NSQIP, Nationwide Inpatient Sample, etc.) carries significant challenges and limitations. With respect to the SVS Vascular Quality Initiative (VQI) specifically, it is a procedural registry, resulting in an inherent treatment selection bias in the data. Compounding this, the “long-term” (i.e., one-year) outcomes in the VQI are notoriously incomplete, illustrated by the referenced paper where the chosen endpoint of major amputation was missing in 40% of the endovascular cohort. The reported 99% one-year patency for open bypass is likewise an implausible result that undermines confidence in the study itself.

We need contemporary research focused on clarifying who is likely to attain a meaningful benefit from revascularization for IC, and who should continue with medical management and exercise therapy. Patient factors such as age and comorbidities, functional capacity and anatomic factors (level and complexity of disease; unilateral versus bilateral) must be accurately captured and taken into consideration. Large datasets such as the SVS VQI can complement prospective IC research if used thoughtfully but require significant improvement in capture of relevant datapoints and/or linkage to other datasets (e.g., VQI-VISION) to address key questions in long-term outcomes (which SVS guidelines¹³ have defined as at least two years). The referenced study is far off base in its endpoint, data quality and analysis, and will likely be interpreted by those with bias towards intervention as affirmatory.

The vascular community has a duty to our patients to uphold the highest standards of clinical care and research. Any amputation after an IC intervention likely represents avoidable iatrogenic harm. The recent SVS CPG update² highlights the importance of shared decision-making in IC with a full understanding of the individual risks and benefits for intervention. The mission of the SVS VQI is to “improve the quality, safety, effectiveness and cost of vascular healthcare.” To achieve this goal, clinical care and research must prioritize patient-centered outcomes, rigorous study designs and appropriate care that minimizes procedural overuse. We must resist the easy path of procedural justification disguised in the language of data science—our field doesn’t need more volume, it needs more meaning.

References

1. Dormandy J, Heeck L, Vig S. The natural history of claudication: risk to life and limb. Semin Vasc Surg. Jun 1999;12(2):123–37
2. Conte MS, Aulivola B, Barshes NR et al. Society for Vascular Surgery Clinical Practice Guideline on the management of intermittent claudication: Focused update. J Vasc Surg. Aug 2025;82(2):303–326 e11. doi:10.1016/j.jvs.2025.04.041
3. 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. doi:10.1016/j. jvs.2022.04.012
4. Bath J, Lawrence PF, Neal D et al. Endovascular interventions for claudication do not meet minimum standards for the Society for Vascular Surgery efficacy guidelines. J Vasc Surg. May 2021;73(5):1693–1700 e3. doi:10.1016/j. jvs.2020.10.067
5. Thanigaimani S, Phie J, Sharma C et al. Network Meta-Analysis Comparing the Outcomes of Treatments for Intermittent Claudication Tested in Randomized Controlled Trials. J Am Heart Assoc. May 4 2021;10(9):e019672. doi:10.1161/ JAHA.120.019672
6. Dun C, Stonko DP, Bose S et al. Trends and Factors Associated With Peripheral Vascular Interventions for the Treatment of Claudication From 2011 to 2022: A National Medicare Cohort Study. J Am Heart Assoc. Jul 16 2024;13(14):e033463. doi:10.1161/JAHA.123.033463
7. Creswell J, Abelson R. Medicare Payments Surge for Stents to Unblock Vessels in Limbs. New York Times. Jan 29, 2015. Accessed April 8, 2021
8. Thomas K. They Lost Their Legs; Doctors and Healthcare Giants Profited. New York Times. July 16, 2023. Accessed May 2, 2025. https://www.nytimes.com/2023/07/15/health/atherectomy-peripheral-artery-disease.html
9. Waldman A. Researchers Warned of Possible Vascular Procedure Abuse. . ProPublica. December 12, 2023. Accessed March 16, 2024. https://www.propublica.org/article/researchers-warned-of-possible-vascular-procedure-abuse-doctors-pushed-back
10. Waldman A. Steak Dinners, Sales Reps and Risky Procedures. ProPublica. February 16, 2023. Accessed March 16, 2024. https://www.propublica.org/article/medtronic-medical-device-kickbacks-lawsuit-kansas
11. Waldman A. In the “Wild West” of Outpatient Vascular Care, Doctors can Reap Huge Payments as Patients Risk Life and Limb. ProPublica. May 24, 2023. Accessed May 2, 2024. https://www.propublica.org/article/maryland-dormu-minimally-invasive-vascular-medicare-medicaid
12. Bellomo TR, Jabbour G, Manchella M, et al. Endovascular Therapy, Open Surgical Bypass, and Conduit Types for Index Treatment of Claudication. JAMA Netw Open. Oct 1 2025;8(10):e2533352. doi:10.1001/jamanetworkopen.2025.33352
13. Society for Vascular Surgery Lower Extremity Guidelines Writing G, Conte MS, Pomposelli FB 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. doi:10.1016/j.jvs.2014.12.009

Authored by Benjamin S. Brooke, MD, Michael S. Conte, MD, Elizabeth L. George, MD, Jens Eldrup-Jorgensen, MD, Leigh Ann O’Banion, MD, Karen Woo, MD, and Jessica P. Simons, MD.