Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-elutin...Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-eluting stents(DP-DES).The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.Methods:Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence.CPCI included at least one of the following features:unprotected left main lesion,≥2 lesions treated,≥2 stents implanted,total stent length>40 mm,moderate-to-severe calcified lesion,chronic total occlusion,or bifurcated target lesion.The primary endpoint was major adverse cardiac events(MACE)including all-cause death,recurrent myocardial infarction,and total coronary revascularization(target lesion revascularization,target vessel revascularization[TVR],and non-TVR)during the 5-year follow-up.The secondary endpoint was total coronary revascularization.Results:Among the 7712 patients included,4882(63.3%)underwent CPCI.Compared with non-CPCI patients,CPCI patients had higher 2-and 5-year incidences of MACE and total coronary revascularization.Following multivariable adjustment including stent type,CPCI was an independent predictor of MACE(adjusted hazard ratio[aHR]:1.151;95%confidence interval[CI]:1.017–1.303,P=0.026)and total coronary revascularization(aHR:1.199;95%CI:1.037–1.388,P=0.014)at 5 years.The results were consistent at the 2-year endpoints.In patients with CPCI,BP-DES use was associated with significantly higher MACE rates at 5 years(aHR:1.256;95%CI:1.078–1.462,P=0.003)and total coronary revascularization(aHR:1.257;95%CI:1.052–1.502,P=0.012)compared with that of DP-DES,but there was a similar risk at 2 years.However,BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.Conclusions:Patients underwent CPCI remained at a higher risk of mid-to long-term adverse events regardless of the stent type.The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.展开更多
基金supported by the National Key Research and Development Program of China(Nos.2016YFC1301300 and 2016YFC1301301)National Clinical Research Center for Cardiovascular Diseases,Fuwai Hospital,Chinese Academy of Medical Sciences(No.NCRC2020013)+1 种基金Chinese Academy of Medical Sciences(CAMS)Innovation Fund for Medical Sciences(CIFMS)(No.2020-I2M-C&T-B-049)the National Natural Science Foundation for Young Scholars of China(No.81900323).
文摘Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-eluting stents(DP-DES).The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.Methods:Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence.CPCI included at least one of the following features:unprotected left main lesion,≥2 lesions treated,≥2 stents implanted,total stent length>40 mm,moderate-to-severe calcified lesion,chronic total occlusion,or bifurcated target lesion.The primary endpoint was major adverse cardiac events(MACE)including all-cause death,recurrent myocardial infarction,and total coronary revascularization(target lesion revascularization,target vessel revascularization[TVR],and non-TVR)during the 5-year follow-up.The secondary endpoint was total coronary revascularization.Results:Among the 7712 patients included,4882(63.3%)underwent CPCI.Compared with non-CPCI patients,CPCI patients had higher 2-and 5-year incidences of MACE and total coronary revascularization.Following multivariable adjustment including stent type,CPCI was an independent predictor of MACE(adjusted hazard ratio[aHR]:1.151;95%confidence interval[CI]:1.017–1.303,P=0.026)and total coronary revascularization(aHR:1.199;95%CI:1.037–1.388,P=0.014)at 5 years.The results were consistent at the 2-year endpoints.In patients with CPCI,BP-DES use was associated with significantly higher MACE rates at 5 years(aHR:1.256;95%CI:1.078–1.462,P=0.003)and total coronary revascularization(aHR:1.257;95%CI:1.052–1.502,P=0.012)compared with that of DP-DES,but there was a similar risk at 2 years.However,BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.Conclusions:Patients underwent CPCI remained at a higher risk of mid-to long-term adverse events regardless of the stent type.The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.