Abstract
OBJECTIVES: Recently, drug-coated balloons (DCB) have emerged as a promising alternative for side branch treatment in coronary bifurcation lesions, in combination with drug-eluting stent (DES) implantation in the main vessel, the hybrid DCB approach. We aimed to evaluate clinical outcomes in patients treated with the hybrid DCB approach and to compare this strategy with other bifurcation techniques. DESIGN: A systematic review and meta-analysis. DATA SOURCES: MEDLINE and EMBASE were searched up until January 2025. ELIGIBILITY CRITERIA: We included randomised controlled trials and observational studies investigating clinical outcomes in patients treated with the hybrid DCB approach for coronary bifurcation lesions. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data and assessed the risk of bias. The outcome of interest was the combined endpoint of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR) at the longest available follow-up. Crude event rates, stratified by treatment strategy, were provided for the overall incidence of the primary endpoint. Furthermore, we conducted meta-analyses on the combined endpoint, comparing different bifurcation percutaneous coronary intervention (PCI) strategies. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. RESULTS: 13 studies, consisting of 2393 patients, were included in our systematic review. Investigated techniques were the hybrid DCB approach in all studies, and a two-stent strategy or the combination of DES in main vessel and balloon angioplasty (BA) in the side branch as potential comparators. Median follow-up duration was 12 months (IQR 7.5-12). The combined endpoint of cardiac death, MI or TLR was found in 5.6% in the hybrid DCB group, 15.4% in the two-stent group and in 10.0% in the BA group. The pooled analyses, including three and two studies, respectively, showed that the hybrid DCB approach was associated with a lower risk of the composite endpoint of cardiac death, MI or TLR when compared with a two-stent strategy (7.9% vs 15.4%; risk ratio (RR): 0.53; 95% CI 0.33 to 0.85) and compared with BA in the side branch (5.6% vs 10.0%; RR: 0.57; 95% CI 0.37 to 0.88). The certainty of the evidence was graded as very low. CONCLUSION: The results of this systematic review and meta-analysis suggest that the hybrid DCB approach is a feasible and promising treatment approach for bifurcation lesions, when compared with other bifurcation PCI strategies. However, the results should be interpreted cautiously as the certainty of evidence was graded as very low, underlining the importance of larger trials to confirm these findings. TRIAL REGISTRATION NUMBER: CRD420250651469.