Endovascular Treatment of Infrainguinal Peripheral Artery Disease with Stent Versus Non-Stent Strategies in the XLPAD Registry.

Background: Anatomic location of infrainguinal peripheral arteries has continually challenged endovascular revascularization strategies based on the use of stent vs. non-stent strategies.

Objective: To compare stent vs. non-stent outcomes of patients enrolled in the multicenter, core laboratory adjudicated XLPAD registry (NCT01904851) between 2005-2023.

Methods: We analyzed 12-month cumulative incidence of major adverse cardiac and vascular events (MACVE), a composite outcome of all-cause death, non-fatal myocardial infarction, stroke, lower limb revascularization and any amputation in patients treated with clinically indicated stent or non-stent 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.

Results: 5,067 patients (5,876 lesions), mean age 67.2 ± 10.3 years, underwent stent (n=2,571) or non-stent (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 non-stent 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 non-stent (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 - 1.370; p=0.013). The stented group had 29.6% increased odds of MACVE compared to non-stent (adjusted OR, 1.296, 95% CI: 1.115 - 1.506, p = 0.001), even after adjusting for residual confounders with propensity matching.

Conclusions: Stent-based interventions are used to treat more complex infrainguinal PAD, with greater procedural success, but higher 12-month MACVE compared with non-stent interventions.