Long-term Efficacy And Safety Of Novel Biodegradable Polymer–coated Cobalt-chromium Sirolimus-eluting Stents In Patients With Coronary Artery Disease 4 Year Clinical Outcomes Of The I-LOVE-IT 2 Trial

Objective: The aim of our study was to compare the long-term efficacy and safety of novel biodegradable polymer cobalt-chromium sirolimus-eluting stent(BP-SES)with durable polymer sirolimus-eluting stent(DP-SES).In addition,we aim to explore the efficacy of 6-month DAPT after implantation of a novel BP-SES.Methods: Our study demonstrated 4-year clinical outcomes of the I-LOVE-IT 2 trial.In this prospective,single-blind,randomized I-LOVE-IT 2 trial conducted at 32 Chinese sites,2,737 patients eligible for coronary stents were treated with BP-or DPSES in a 2:1 ratio.Patients allocated to the BP-SES group were also randomized to receive either 6-month or 12-month DAPT(in a 1:1 ratio).The primary endpoint was 4 year target lesion failure(TLF),a composite of cardiac death,target vessel myocardial infarction(TVMI),or clinically indicated target lesion revascularization(CI-TLR).Secondary endpoints included TLF components,4 year net adverse clinical and cerebral events(NACCE),a composite of all cause death,all MI,stroke and severe bleeding,NACCE components,patient-oriented composite endpoint(Po CE),a composite of all cause death,all MI and any revascularization,Po CE components and definite/probable stent thrombosis(ST).Results: At 4 years,the difference in the primary endpoint of TLF between BP-SES and DP-SES groups was 0.4%(9.9% vs.9.5%,95% confidence interval(CI):-1.9% to 2.8%,P for non-inferiority=0.0003),demonstrating non-inferiority of BP-SES to DPSES.Individual TLF components of cardiac death(1.8% vs.1.5%,P =0.62),TVMI(4.6% vs.5.3%,P =0.43),and CI-TLR(5.2% vs.4.7%,P =0.61)were similar,as well as both groups had a low definite/probable ST(0.9% vs.1.0%,P =0.88).The rate of other secondary endpoints includes Po CE and NACCE were also similarly(20.1% vs.20.3%,P =0.93 and 26.4% vs.28.1%,P =0.34,respectively).At 4 years,the difference in the primary endpoint of TLF between 6-month DAPT group and 12-month DAPT after implantation of a novel BP-SES group was 0.4%(10.1% vs.9.7%,95%,confidence interval(CI):-3.2% to 2.3%,P for non-inferiority=0.0099),demonstrating non-inferiority of 6-month DAPT to 12-month DAPT.Individual TLF components of cardiac death(1.4% vs.2.2%,P =0.23),target vessel myocardial infarction(5.3% vs.3.9%,P=0.16),and clinically indicated target lesion revascularization(5.6% vs.4.8%,P =0.43)were similar,as were low definite/probable stent thrombosis rates(1.3% vs.0.5%,P =0.09)in both groups,as well as the secondary end point of major bleeding(Bleeding Academic Research Consortium type ?3)and NACCE(1.9% vs.1.2%,P =0.24 and 25.6% vs.27.1% P =0.49,respectively).Conclusions: In this large-scale real-world trial,BP-SES was non-inferior to DP-SES for 4 year TLF.(Evaluate Safety and Effectiveness of the BP-DES and the DP-DES for Treatment of Coronary Revascularization).In addition,6-month DAPT was noninferior in safety and efficacy to 12 month DAPT after implantation of a novel biodegradable polymer sirolimus-eluting stent.