Drug-Coated Balloons Show Promise Over Stents in Coronary Bifurcation Side Branch Lesions

The optimal strategy for managing side branch lesions in true coronary bifurcations has long challenged interventional cardiologists, particularly given concerns surrounding permanent metallic implants. A new systematic review and meta-analysis suggests that drug-coated balloons (DCBs) may offer a clinically meaningful alternative to drug-eluting stents (DES), with potential advantages in both efficacy and vascular healing.

Drawing on five randomized and observational studies encompassing 898 patients, investigators compared paclitaxel-coated DCBs with limus-eluting DES specifically for the treatment of side branch lesions in bifurcation percutaneous coronary intervention (PCI). The analysis focused on major adverse cardiac events (MACE)—a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR)—alongside several secondary endpoints, including restenosis and mortality.

Across pooled random-effects models, DCB use was associated with a significant reduction in MACE, with an odds ratio of 0.48 (95% CI, 0.27–0.81; p=0.008). This translated to nearly a 50% relative reduction in adverse cardiovascular outcomes compared with DES. A similarly pronounced benefit was observed for target lesion revascularization, which occurred less frequently in the DCB group (odds ratio 0.35; 95% CI, 0.19–0.68; p=0.001).

The analysis also identified lower late lumen loss with DCBs across included studies, suggesting improved vessel patency over time. This finding is consistent with the theoretical advantage of a “leave-nothing-behind” approach, in which antiproliferative drug delivery occurs without the need for a permanent scaffold. By avoiding metallic implantation, DCBs may reduce chronic inflammation and late complications associated with stents, particularly in anatomically complex bifurcation lesions.

Importantly, the study did not identify signals suggesting increased risk in key safety endpoints such as myocardial infarction or mortality, although these outcomes were assessed as secondary measures. Risk of bias across the included studies was evaluated using established tools, including RoB 2 for randomized trials and the Newcastle–Ottawa Scale for observational data, supporting the methodological rigor of the analysis.

Despite these encouraging findings, the authors emphasize that the current evidence base remains limited. The relatively small number of studies and modest sample size underscore the need for larger, adequately powered randomized trials to confirm the observed benefits and to better define the role of DCBs in routine bifurcation PCI.

Taken together, the results contribute to a growing body of evidence supporting DCB technology as a viable—and potentially advantageous—strategy for side branch intervention. As interventional cardiology continues to evolve toward approaches that minimize long-term device burden, these findings may help inform future guideline recommendations and procedural decision-making in complex coronary anatomy.