A Meta-Analysis of 3-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small-Vessel Coronary Artery Disease.

Background: Drug-coated balloons (DCBs) may be a viable alternative to drug-eluting stents (DES) for de novo small caliber coronary artery lesions. However, there remains a lack of data regarding the long-term efficacy of this approach. Objectives: The purpose of this study was to compare the rates of major adverse cardiovascular events (MACE) after 3-year follow-up among patients randomized to DCB versus DES for the treatment of small caliber coronary arteries with reference vessel diameter between 2 and 3 mm. Methods: We systematically searched MEDLINE, EMBASE, and CENTRAL databases from their inception to July 2023 for randomized controlled trials comparing DCB versus DES for small caliber coronary artery disease. The primary end point was MACE at 3-year follow-up. Risk of bias was assessed using the Cochrane Risk of Bias Tool (RoB 2). Pooled risk ratios (RRs) and 95% CIs were estimated using random effects meta-analytic models. Results: Four randomized controlled trials (n = 1,402) were included. In total, 706 patients were randomized to DCB and 696 to DES. Participants were mostly male (74%), with a mean/median age ranging from 60 to 68 years. Pooled data across trials for MACE showed wide CIs, with little indication of DES superiority over DCB (RR: 0.71; 95% CI: 0.36-1.41). Most individual components of MACE were inconclusive. There was a potential signal for a reduction of target vessel thrombosis with DCB compared to DES (RR: 0.25; 95% CI: 0.06-1.08). Conclusions: Although sample sizes are small, 3-year outcomes suggest that DCB may be a reasonable alternative to DES for the treatment of small coronary arteries.