Physicians treating chronic limb-threatening ischemia (CLTI) often debate the best endovascular tools, with atherectomy gaining popularity for calcified lesions despite stronger evidence in coronary disease.
The BEST-CLI trial, a landmark randomized study comparing open surgery versus endovascular strategies, provides fresh data on atherectomy's real-world role. In the study published in the JACC: Cardiovascular Intervention, the researchers analyzed 923 patients who received endovascular revascularization, stratifying them by atherectomy use (132 patients, 14.3%) versus other methods. Participants averaged 67.3 years old, with 71.1% men and 72.3% White, reflecting typical high-risk CLTI demographics. They tracked major adverse limb events (MALE), defined as major reintervention or above-ankle amputation in the treated leg, plus secondary outcomes like death.
No Clear Benefit Emerges After Risk Adjustment
After accounting for factors like age, comorbidities, and lesion complexity, atherectomy showed no advantage over standard endovascular techniques such as angioplasty or stenting. The adjusted hazard ratio for MALE reached 1.30 (95% CI 0.92-1.84), indicating similar event rates between groups. Major reintervention carried an aHR of 1.07 (95% CI 0.67-1.73), above-ankle amputation 1.32 (95% CI 0.81-2.15), and all-cause mortality 1.06 (95% CI 0.75-1.49). These findings suggest atherectomy neither prevents limb loss nor extends survival better than less costly alternatives in CLTI patients undergoing endovascular care.
Technical Success Highlights Potential Concerns
A sensitivity analysis restricted to cases achieving technical success revealed a signal of harm, with atherectomy linked to higher MALE rates (unadjusted log-rank P=0.02; aHR 1.51, 95% CI 1.03-2.22). This raises questions about plaque debulking in even well-executed procedures, possibly due to distal embolization or vessel trauma in fragile below-knee arteries. Interventionalists should weigh these risks carefully, especially in diabetes-driven CLTI where calcification complicates stenting.
Implications Reshape CLTI Revascularization Choices
BEST-CLI's prospective design and large endovascular cohort strengthen these conclusions, challenging enthusiasm for atherectomy amid high device costs and procedural times. Vascular specialists now have evidence favoring plain balloon angioplasty, drug-coated balloons, or specialty stents over routine atherectomy. In CLTI case with heavy calcium, clinicians may prioritize inflow optimization and wound care first, reserving atherectomy for bailout only.
Forward Path Prioritizes Proven Strategies
Future trials should explore atherectomy subtypes (orbital, rotational, laser) and long femoropopliteal lesions, but current data urges guideline caution. Multidisciplinary limb teams benefit from this clarity, focusing resources on therapies demonstrating limb salvage gains.
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Key highlights
- Atherectomy use in CLTI endovascular revascularization associates with similar rates of major adverse limb events compared to other techniques after risk adjustment (aHR 1.30).
- No differences emerge in major reintervention (aHR 1.07), above-ankle amputation (aHR 1.32), or all-cause mortality (aHR 1.06) between atherectomy and non-atherectomy groups.
- Among technically successful procedures, atherectomy links to higher MALE risk (aHR 1.51), suggesting potential harm in select cases.
- BEST-CLI data challenges routine atherectomy adoption in CLTI, favoring cost-effective alternatives like drug-coated balloons.
- Physicians should reserve atherectomy for complex calcified lesions unresponsive to standard endovascular approaches.
Source
Hicks CW, Farber A, Doros G, et al. Atherectomy Is Not Associated With Improved Limb-Based Outcomes Among Patients in the BEST-CLI Trial Undergoing Endovascular Revascularization. JACC Cardiovasc Interv. 2026 Jan 12;19(1):96-107. doi: https://doi.org/10.1016/j.jcin.2025.10.065.
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BEST-CLI trial finds atherectomy yields similar or worse limb outcomes versus standard endovascular therapy in CLTI patients, with no major adverse limb event benefit after adjustment.
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