Efficacy and Outcomes of Stenting Versus Balloon Angioplasty for Chronic Limb-Threatening Ischemia in Infrapopliteal Peripheral Arterial Disease: A Meta-Analysis of Randomized Controlled Trials

Abstract

Peripheral arterial disease (PAD) and its severe complication, chronic limb-threatening ischemia (CLTI) are associated with significant morbidity and mortality worldwide. Conventionally, balloon angioplasty has been regarded as superior to stenting in CLTI associated with infrapopliteal PAD. Stenting is often considered a “rescue” or “bail-out” procedure in managing CLTI. However, stenting using newer generation stents coated with antiproliferative drugs such as paclitaxel has demonstrated noninferior results compared with balloon angioplasty in terms of risk of restenosis. However, the current data comparing stenting to balloon angioplasty for other outcomes is rather inconsistent. Major bibliographic databases were searched systematically to identify randomized controlled trials (RCTs) comparing stenting to balloon angioplasty in CLTI in infrapopliteal PAD patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled in a random-effects model with statistical significance considered at P < 0.05. 9 RCTs with 1125 patients (634, stenting; 491, balloon angioplasty) were included. Stenting was associated with a statistically significant reduction in the risk of binary restenosis (RR, 0.61; 95% CI, 0.38–0.97; P = 0.04] compared with balloon angioplasty. However, no statistically significant difference in technical success, all-cause mortality, clinically driven target lesion revascularization, major limb amputation, and primary patency was observed between the 2 groups. In infrapopliteal PAD associated with CLTI, stenting is noninferior to balloon angioplasty. Future large multicentric RCTs are warranted, particularly evaluating the newer generation drug-eluting stents, in a diverse patient population with longer follow-up periods to corroborate the results of this meta-analysis.