摘要
Background:Treatment of coronary bifurcation lesions remains challenging;a simple strategy has been preferred as of late,but the disadvantage is ostium stenosis or even occlusion of the side branch(SB).Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported.This prospective,multicenter,randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon(PEB)compared with regular balloon angioplasty(BA)in the treatment of non-left main coronary artery bifurcation lesions.Methods:Between December 2014 and November 2015,a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers.Patients were randomly allocated at a 1:1 ratio to a PEB group(n=113)and a BA group(n=109).The primary efficacy endpoint was angiographic target lesion stenosis at 9 months.Secondary efficacy and safety endpoints included target lesion revascularization,target vessel revascularization,target lesion failure,major adverse cardiac and cerebral events(MACCEs),all-cause death,cardiac death,non-fatal myocardial infarction,and thrombosis in target lesions.The main analyses performed in this clinical trial included case shedding analysis,base-value equilibrium analysis,effectiveness analysis,and safety analysis.SAS version 9.4 was used for the statistical analyses.Results:At the 9-month angiographic follow-up,the difference in the primary efficacy endpoint of target lesion stenosis between the PEB(28.7%±18.7%)and BA groups(40.0%±19.0%)was-11.3%(95%confidence interval:-16.3%to-6.3%,Psuperiority<0.0001)in the intention-to-treat analysis,and similar results were recorded in the per-protocol analysis,demonstrating the superiority of PEB to BA.Late lumen loss was significantly lower in the PEB group than in the BA group(-0.06±0.32 vs.0.18±0.34 mm,P<0.0001).For intention-to-treat,there were no significant differences between PEB and BA in the 9-month percentages of MACCEs(0.9%vs.3.7%,P=0.16)or non-fatal myocardial infarctions(0 vs.0.9%,P=0.49).There were no clinical events of target lesion revascularization,target vessel revascularization,target lesion failure,all-cause death,cardiac death or target lesion thrombosis in either group.Conclusions:In de novo non-left main coronary artery bifurcations treated with provisional T stenting,SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.Trial registration:ClinicalTrials.gov,NCT02325817;https://clinicaltrials.gov.
