Abstract Background Recently, drug-eluting balloons (DEB) 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. This approach aligns with current guideline recommendations to simplify bifurcation percutaneous coronary intervention (PCI) and minimize stent use. Purpose The aim of this systematic review and meta-analysis is to assess clinical and angiographic outcomes of patients treated with the hybrid DEB approach (DEB in the side branch and DES in the main vessel) and to compare these outcomes to other bifurcation PCI strategies, including a two-stent strategy and implantation of DES in the main vessel and balloon angioplasty in the side branch. Methods A systematic search was performed to identify studies evaluating the hybrid DEB approach for the treatment of coronary bifurcation lesions. Outcomes included target vessel failure (TVF), including cardiac death, myocardial infarction or target vessel revascularization, and late lumen loss (LLL). Furthermore, a meta-analysis was conducted on these outcomes, stratified by bifurcation PCI strategy. Results Twelve articles, consisting of 2325 patients with a bifurcation lesion, were included in our systematic review, encompassing both randomized and non-randomized trials. Median follow-up was 12 months, varying from 6 to 24 months. Most bifurcation lesions (98%) were true bifurcation lesions. Target vessel failure occurred in 5.8% in the hybrid DEB group and in 10.6% and 12.6% in the two-stent and balloon angioplasty groups, respectively. Mean LLL of the side branch was -0.01 ± 0.11mm after DEB application, 0.40 ± 0.04mm after DES implantation, and 0.19 ± 0.01mm after balloon angioplasty. Bifurcation PCI using the hybrid DEB approach was associated with a lower risk of TVF, compared to a two-stent strategy effect size -0.74 (-1.31 to -0.17) and to balloon angioplasty in the side branch effect size -0.58 (-0.98 to -0.18). Late lumen loss was lower in the hybrid DEB group compared to the two-stent and balloon angioplasty groups effect size -0.42 (-0.60 to -0.24) and effect size -0.16 (-0.32 to -0.003), respectively. Conclusion This systematic review shows that the hybrid DEB approach is a safe and feasible strategy for the treatment of coronary bifurcation lesions. Moreover, the meta-analysis indicates that the hybrid DEB approach was associated with a lower incidence of TVF and lower LLL when compared to a two-stent strategy or treatment with balloon angioplasty in the side branch.
Dillen et al. (Sat,) studied this question.