Drug-Coated Balloons for De Novo Non–aorto-ostial and Coronary Bifurcation Lesions: A Systematic Review and Meta-analysis
Background Stenting of bifurcation and non–aorto-ostial coronary lesions presents significant challenges due to geographic miss and restenosis. Drug-coated balloons (DCBs) offer an attractive alternative to drug-eluting stents in the treatment of these lesions. Methods We conducted a systematic review of studies published from 2001 to 2024 comparing DCBs with plain old balloon angioplasty and/or drug-eluting stents (DES) in de novo coronary bifurcation lesions and non–aorto-ostial (NAO) lesions. A meta-analysis was performed with target lesion failure (TLF) as the selected outcome, defined as a composite of target lesion revascularization, target vessel myocardial infarction, or cardiovascular death. Results Eleven studies (4 randomized controlled trials and 7 observational) comprising 2443 patients were included. The median follow-up was 12 months. A random-effects model was applied to account for differences in study design and population despite a low heterogeneity among the studies (I 2 < 25%). The pooled risk ratio (RR) for TLF was 0.52 (95% CI, 0.40-0.68; P < .0001). Subgroup analysis for randomized controlled trials, coronary bifurcation lesions, NAO lesions, and DES comparator revealed RRs of 0.55 (95% CI, 0.36-0.83; P = .0043), 0.51 (95% CI, 0.38-0.70; P < .0001), 0.54 (95% CI, 0.31-0.95; P = .034), and 0.53 (95% CI, 0.36-0.79; P = .0015), respectively. Conclusions In our meta-analysis, DCBs were associated with a lower rate of TLF compared with plain old balloon angioplasty and DES. These findings suggest that DCBs could be preferred for the treatment of bifurcation and NAO lesions.
