Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world settin...Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective,multicenter,cohort study conducted at 38 centers across China between November 2018 and December 2019.A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria.The primary endpoint was target lesion failure(TLF),defined as a composite of cardiac death,non-fatal target vessel myocardial infarction(MI),and clinically indicated target lesion revascularization(TLR)at 1-year follow-up.Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998(98.0%)patients completed the 1-year follow-up.The 1-year incidence of TLF was 3.10%(94/2998,95%closed interval:2.54-3.78%).The rates of cardiac death,non-fatal target vessel MI and clinically indicated TLR were 2.33%(70/2998),0.20%(6/2998),and 0.70%(21/2998),respectively.The rate of stent thrombosis was 0.33%(10/2998).Age≥60 years,diabetes mellitus,family history of coronary artery disease,acute myocardial infarction at admission,and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10%and 0.33%,respectively,in patients treated with HELIOS stents.Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov,NCT03916432.展开更多
文摘Background:The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer.The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.Methods:The HELIOS registry is a prospective,multicenter,cohort study conducted at 38 centers across China between November 2018 and December 2019.A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria.The primary endpoint was target lesion failure(TLF),defined as a composite of cardiac death,non-fatal target vessel myocardial infarction(MI),and clinically indicated target lesion revascularization(TLR)at 1-year follow-up.Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.Results:A total of 2998(98.0%)patients completed the 1-year follow-up.The 1-year incidence of TLF was 3.10%(94/2998,95%closed interval:2.54-3.78%).The rates of cardiac death,non-fatal target vessel MI and clinically indicated TLR were 2.33%(70/2998),0.20%(6/2998),and 0.70%(21/2998),respectively.The rate of stent thrombosis was 0.33%(10/2998).Age≥60 years,diabetes mellitus,family history of coronary artery disease,acute myocardial infarction at admission,and device success were independent predictors of TLF at 1 year.Conclusion:The 1-year incidence rates of TLF and stent thrombosis were 3.10%and 0.33%,respectively,in patients treated with HELIOS stents.Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.Clinical trial registration:ClinicalTrials.gov,NCT03916432.
