Drug-coated balloons for the treatment of in-stent restenosis: an updated systematic review and meta-analysis of randomized controlled trials

Background: Drug-coated balloons (DCBs) have emerged as a potential option for treating in-stent restenosis (ISR). We aimed to assess the efficacy and safety of DCB compared to uncoated balloons (UCBs) for patients with ISR. Methods: We systematically searched Embase, MEDLINE, and Cochrane Library for randomized controlled trials comparing drug-coated balloons with uncoated balloons for coronary in-stent restenosis (ISR). Dichotomous and continuous outcomes were pooled using Revman 5.4 under a random-effects model. All the outcomes were assessed in a 6-month to 1-year follow-up period. Results: A total of seven RCTs involving 1407 patients were included in our review. DCBs significantly reduced the rate of target lesion revascularization (TLR) (RR 0.28; 95% CI: 0.16, 0.48), target vessel revascularization (TVR) (RR 0.36; 95% CI: 0.14, 0.90), major adverse cardiovascular events (MACE) (RR 0.39; 95% CI: 0.26, 0.58), and MI (RR 0.56; 95% CI: 0.35, 0.91). However, no significant difference was observed between the two groups regarding all-cause mortality, cardiovascular mortality, and stent thrombosis. DCB significantly improved angiographic outcomes such as binary restenosis (RR 0.23; 95% CI: 0.12, 0.43), late lumen loss (MD -0.44; 95% CI: - 0.55 to -0.33), and percent diameter stenosis (MD -13.91; 95% CI: - 24.15 to -3.67) compared to the UCB group. Conclusion: Our meta-analysis showed that drug-coated balloons have superior efficacy and safety compared to uncoated balloons in coronary in-stent restenosis patients.