Purpose: The present meta-analysis evaluated the role of drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) in femoropopliteal artery disease.
Materials and methods: Cochrane Library, Embase, and PubMed were searched without language restrictions from inception to May 10, 2020. The endpoints included target lesion revascularization (TLR), recurrent ISR, clinical improvement, ankle-brachial index (ABI), and death. There were 5 randomized controlled trials with 425 patients (218 with DCB angioplasty and 207 with plain old balloon angioplasty [POBA]) were included in the meta-analysis.
Results: Compared with POBA, DCB angioplasty was associated with lower risk of TLR (odds ratio [OR], 0.21; 95% confidence interval [CI]: 0.09-0.49, P < .001 at 6 months and OR, 0.15; 95% CI, 0.08-0.30; P < .001 at 12 months) and recurrent ISR (OR, 0.22; 95% CI, 0.13-0.38; P < .001 at 6 months and OR, 0.31; 95% CI, 0.16-0.61; P < .001 at 12 months), and superior clinical improvement (OR, 1.98; 95% CI, 1.07-3.65; P = .03 at 6 months and OR, 2.84; 95% CI: 1.50-5.35; P = .001 at 12 months). There were no significant differences between groups in ABI and death. Subgroup analysis for patients with DCB angioplasty showed similar rates of TLR, recurrent ISR, clinical improvement, and death between the short lesion (<15 cm) and long lesion group (≥15 cm) (P > .05).
Conclusions: The current meta-analysis suggests that DCB angioplasty is an improvement over POBA for femoropopliteal ISR. Future studies about the effect of lesion length on DCB performance are still needed.
Copyright © 2021 SIR. Published by Elsevier Inc. All rights reserved.