Comparison of Hybrid Strategy With Drug-Coated Balloons Versus Stent-Only Strategy for Coronary Bifurcation Lesions: A Systematic Review and Meta-Analysis

Background

Coronary bifurcation lesions (CBLs) account for approximately 15%–20% of all percutaneous coronary interventions and remain a therapeutic challenge. A hybrid strategy combining drug-coated balloons (DCBs) for the side branch with drug-eluting stents (DESs) for the main vessel has emerged as a novel therapy aimed at mitigating complications associated with permanent implants. This study was aimed at systematically evaluating the efficacy and safety of the hybrid strategy compared with a DES-only strategy (including single- and double-stent strategies) in CBLs.

Methods

Following the PRISMA 2020 guidelines, we systematically searched major databases for randomized controlled trials (RCTs) and observational studies comparing the DES + DCB hybrid strategy with a DES-only strategy for CBLs. The primary endpoint was major adverse cardiovascular events (MACE). Secondary endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), late lumen loss (LLL), myocardial infarction (MI), and restenosis rate. Statistical analyses were performed using RevMan 5.4 and StataMP.

Results

We included 13 studies, comprising five RCTs and eight observational studies, with a total of 2186 patients (1030 in the hybrid strategy group and 1156 in the DES-only group). Compared with the DES-only strategy, the hybrid strategy was associated with a lower incidence of MACE (OR 0.75; 95% CI 0.57–0.99; p = 0.04) and a lower risk of TLR (OR 0.46; 95% CI 0.26–0.79; p = 0.005); however, the MACE benefit was of borderline statistical significance. Regarding angiographic endpoints, the hybrid strategy substantially lowered the risk of side branch restenosis (OR 0.13; 95% CI 0.05–0.34; p < 0.0001). Side branch LLL was consistently lower with the hybrid strategy across all contributing studies; however, extreme between-study heterogeneity (I² = 96%) precluded meaningful pooling. Subgroup analysis indicated a more pronounced reduction in MACE risk for left main lesions (OR 0.50; 95% CI 0.31–0.81; p = 0.005), with extremely low heterogeneity (I² = 0%). No statistically significant differences were observed between the two groups with respect to MI or TVR.

Conclusions

For CBLs, the DES + DCB hybrid strategy appears to offer favorable safety and efficacy compared with a stent-only strategy. The observed benefits likely reflect both the avoidance of a second permanent stent implant and the localized antiproliferative drug delivery by the DCB, collectively reducing side branch restenosis and TLR. These findings support the hybrid approach as a promising alternative to complex double-stent techniques, although large-scale RCTs are warranted to confirm these results.