Femoropopliteal Artery Atherectomy for Symptomatic Peripheral Artery Disease in the XLPAD Registry.

Despite widespread use of atherectomy in endovascular treatment of peripheral artery disease (PAD), it remains unsupported by major international guidelines, due to insufficient evidence of efficacy. This study compared atherectomy and nonatherectomy-based endovascular revascularization for femoropopliteal (FP) artery PAD. We analyzed data from the multicenter XLPAD registry (27 U.S. sites, 2007-2024; NCT01904851) to compare atherectomy versus nonatherectomy interventions for treating FP PAD. The primary outcome was technical failure or need for stenting during the index procedure. Technical failure was defined as the inability to cross the target lesion with a guidewire or a > 30% angiographic residual stenosis following endovascular intervention. Secondary outcomes included periprocedural complication and 1-year major adverse limb events (MALE), a composite of all-cause mortality, clinically driven target lesion revascularization (CD-TLR), and major amputation. Periprocedural (up to 30 days postprocedure) complications included bleeding, hematoma >5 cm, flow-limiting dissection, perforation, distal embolization, and emergency surgery. Of the 4,912 patients, 1,635 (33.3%) underwent intervention with atherectomy and 3,277 (66.7%) without. The mean age was 66.8 ± 10 years; 29% were female, and 80% were Caucasian. Comorbidities including diabetes mellitus (53%), chronic kidney disease (15%), and chronic limb-threatening ischemia (37.6%) were similar across groups. Atherectomy was more frequently used in more complex lesions. The primary outcome occurred in 35% of the atherectomy group versus 67% in the nonatherectomy group (p <0.001; odds ratio 0.28, 95% confidence interval 0.24-0.32), with lower stent utilization (33.6% vs 61.0%; p <0.001) and fewer technical failures (1.7% vs 6.7%; p <0.001) in the atherectomy group. Periprocedural complication rates were similar (6.6% in both groups); distal embolization was significantly higher with atherectomy (1.2% vs 0.4%; p <0.001). At follow-up, the atherectomy group exhibited lower major amputation (2.6% vs 4.3%; p = 0.003), and a numerically lower CD-TLR (3.7% vs 4.1%; p = 0.6). One-year MALE was significantly lower in atherectomy group (9.2% vs 11.6%; p = 0.011). Atherectomy is more frequently used in complex FP interventions and is associated with higher technical success, reduced stent use, and significantly lower 1-year MALE rates, albeit with a higher periprocedural distal embolization.