Endovascular Treatment of Infrainguinal Peripheral Artery Disease With Stent Versus Nonstent Strategies in the XLPAD Registry

Abstract

Anatomic location of infrainguinal peripheral arteries has continually challenged endovascular revascularization strategies based on the use of stent vs. nonstent strategies. The objective of our study is to compare stent vs. nonstent outcomes of patients enrolled in the multicenter, core laboratory adjudicated XLPAD registry (NCT01904851) between 2005 and 2023. We analyzed 12-month cumulative incidence of major adverse cardiac and vascular events (MACVE), a composite outcome of all-cause death, nonfatal myocardial infarction, stroke, lower limb revascularization and any amputation in patients treated with clinically indicated stent or nonstent interventions, analyzed within a competing risk framework; group differences assessed using the Gray's test. To minimize confounding bias, we also implemented propensity score matching. About 5,067 patients (5,876 lesions), mean age 67.2 ± 10.3 years, underwent stent (n = 2,571) or nonstent (n = 2,496) predominantly femoropopliteal artery (68%) interventions. 42.8% were current smokers, 57.3% diabetic; 17% had chronic kidney disease and 56.5% coronary artery disease. 50.7% presented with Rutherford class (II-III) symptoms, with mean ankle-brachial index 0.64 ± 0.24. 61% lesions in stent group and 38.6% in the nonstent group had chronic total occlusions (p <0.001). Significantly greater calcified (36.6% vs. 33%; p = 0.004) and longer lesions (142.9 ± 96.5 mm vs. 115.8 ± 91.3 mm; p <0.001) were treated in the stented group. Drug-coated balloon and atherectomy use were 18% and 34.2%, respectively. Procedural success was higher in the stent group (96.9% vs. 89.5%; p <0.001). Peri-procedural period flow-limiting dissections were higher in the stent (2.7% vs. 0.3%; p <0.001), and any amputation in the nonstent (3.0% vs. 4.4%; p = 0.008). 12-month MACVE was higher in the stent group (22.2% vs. 19.2%, p = 0.009) mainly driven by greater need for repeat endovascular revascularization (13.1% vs. 10.4%, p = 0.003), and this was consistent even after adjusting for chronic limb threatening ischemia presentation (adjusted odds ratio [OR], 1.193; 95% confidence interval [CI], 1.039 to 1.370; p = 0.013). The stented group had 29.6% increased odds of MACVE compared to nonstent (adjusted OR, 1.296, 95% CI: 1.115 to 1.506, p = 0.001), even after adjusting for residual confounders with propensity matching. Stent-based interventions are used to treat more complex infrainguinal PAD, with greater procedural success, but higher 12-month MACVE compared with nonstent interventions.

Keywords: critical limb threatening ischemia; intermittent claudication; peripheral artery disease.