Comparison Of Drug-Coated Balloons Alone With Provisional Side-Branch Stenting Strategy For De-Novo True Coronary Bifurcation Lesions

Background: It’s still controversial regarding an optimal treatment of coronary bifurcation lesions(CBLs).Despite drug-coated balloon(DCB)may be superior to drug-eluting stent(DES)due to less device-caused carina or plaque shifting,The available data remains insufficient to prove the benefits as using DCB only to treat CBLs particularly true CBLs.Objectives: This study sought to explore the safety and efficacy of DCB-only strategy for treatment of de novo true CBLs compared with provisional side-branch stenting strategy.Methods: 30 consecutive patients with true CBLs treated by DCB-only were included(DCB-only group),anther 30 patients treated by provisional side-branch stenting(PSS)were matched by propensity score matching(PSS-based group).All patients underwent 9-month angiographic and 12-month clinical follow-up.The primary endpoint was the late lumen loss(LLL)and major adverse cardiovascular events(MACE)composed of cardiac death(CD),myocardial infarction(MI),target lesion thrombosis(ST),or target vessel/lesion revascularization(TLR/TVR);the secondary endpoint was minimal lumen diameter(MLD),diameter stenosis percentage(DSP)or binary restenosis(BRS)and MACE components.Then statistical differences of each endpoint event between the two groups were assessed.Results: The baseline clinical and lesion’s characteristics were comparable between the groups.Angiographic follow-up showed that compared to PSS-based group,DCB-only group had lower LLL in proximal main-branch(0.16±0.10 mm vs.0.20±0.09 mm,P=0.147),distal main-branch(0.16±0.07 mm vs.0.23±0.05 mm,P<0.001)and side-branch(-0.10±0.21 mm vs.0.00±0.10 mm,P=0.013);larger MLD in side-branch(1.08±0.56 mm vs.0.80±0.59 mm,P=0.048)and lower DSP in side-branch(50.0±17.7% vs.65.5±23.6%,P=0.006),and similar BRS in main-vessel(0.0% vs.3.3%,P=1.0)and side-branch(40.0% vs.63.3%,P=0.120).Clinical follow-up showed that there was no CD,MI and ST in both groups,TLR/TVR occurred in 2 patients in PSS-based group.The cumulative MACE(0%vs.6.7%,P=0.472)was low and similar and the Kaplan-Meier cumulative MACE-free survival(100% vs.93.3%,log-rank test;P=0.154)was also comparable between the groups.Conclusion: Compared to PSS strategy,DCB-only strategy is safe and effective in treatment of the selected TCBLs.