BACKGROUND The use of biodegradable polymer drug-eluting stents(BP-DES)has been proven to minimize restenosis and stent thrombosis.The current post-marketing monitoring was observed at the 5-year clinical outcomes of ...BACKGROUND The use of biodegradable polymer drug-eluting stents(BP-DES)has been proven to minimize restenosis and stent thrombosis.The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap®DES in the real world.AIM To assess the safety and effectiveness of FlexyRap®DES at the 5-year follow-up in real-world settings.METHODS Findings from a retrospective,multi-center,observational,post-market clinical follow-up study of patients treated with FlexyRap®DES for de novo coronary artery disease(CAD)were reported.During the 12-mo follow-up,the primary endpoint was target lesion failure,which was defined as the composite of cardiovascular death, target vessel myocardial infarction(TV-MI), and clinically driven target lesion revascularization.RESULTS The data of 500 patients received with FlexyRap®DES was obtained at the completion of the surveillance timeline of 5-year.After the implantation of FlexyRap®DES,the device success rate was 100%.Adverse events that led to major bleeding,permanent disability,or death were not experienced in the patients.The major adverse cardiac event rate at 12-mo,3-year,and 5-year follow-up was 1(0.2%),0(0%),and 1(0.2%)respectively with 0(0%)cardiovascular death,2(0.4%)TV-MI,and 0(0%)TLR compositely.Furthermore,late stent thrombosis was found in 2(0.4%)patients at the follow-up of 12-mo,very late stent thrombosis was observed in 2 patients(0.4%)at 3-year follow-up.CONCLUSION FlexyRap®DES was proved to be safe and efficacious in real-world patients with de novo CAD,indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.展开更多
目的运用Meta分析评价涂层可生物降解药物洗脱支架(BP-SES)在小血管介入中的疗效。方法检索知网、维普、万方、SinoMed、Embase、PubMed、Cochrane Library、Web of Science数据库,搜集BP-SES治疗小血管病变的随机对照实验,时间为建库起...目的运用Meta分析评价涂层可生物降解药物洗脱支架(BP-SES)在小血管介入中的疗效。方法检索知网、维普、万方、SinoMed、Embase、PubMed、Cochrane Library、Web of Science数据库,搜集BP-SES治疗小血管病变的随机对照实验,时间为建库起至2022年8月15日,采用Revman 5.4.1软件进行Meta分析。结果共纳入5项RCTs,共4248例患者,结果显示:BP-SES在改善大、小血管病变支架内再狭窄[RR=0.77,95%CI(0.31,1.90),P=0.58]、支架内血栓[RR=1.34,95%CI(0.54,3.37),P=0.53]、靶血管血运重建[RR=1.18,95%CI(0.80,1.74),P=0.39]、全因死亡[RR=1.25,95%CI(0.85,1.83),P=0.26]、心因性死亡[RR=1.62,95%CI(0.54,4.86),P=0.39]、非致死性心梗[RR=1.28,95%CI(0.84,1.93),P=0.25]和MACE事件[RR=1.42,95%CI(0.91,2.21),P=0.12]发生率差别不具有统计学意义。结论BP-SES治疗冠状动脉小血管病变的有效性和安全性与大血管相近,可以在临床上应用。展开更多
文摘BACKGROUND The use of biodegradable polymer drug-eluting stents(BP-DES)has been proven to minimize restenosis and stent thrombosis.The current post-marketing monitoring was observed at the 5-year clinical outcomes of individuals who had been treated with FlexyRap®DES in the real world.AIM To assess the safety and effectiveness of FlexyRap®DES at the 5-year follow-up in real-world settings.METHODS Findings from a retrospective,multi-center,observational,post-market clinical follow-up study of patients treated with FlexyRap®DES for de novo coronary artery disease(CAD)were reported.During the 12-mo follow-up,the primary endpoint was target lesion failure,which was defined as the composite of cardiovascular death, target vessel myocardial infarction(TV-MI), and clinically driven target lesion revascularization.RESULTS The data of 500 patients received with FlexyRap®DES was obtained at the completion of the surveillance timeline of 5-year.After the implantation of FlexyRap®DES,the device success rate was 100%.Adverse events that led to major bleeding,permanent disability,or death were not experienced in the patients.The major adverse cardiac event rate at 12-mo,3-year,and 5-year follow-up was 1(0.2%),0(0%),and 1(0.2%)respectively with 0(0%)cardiovascular death,2(0.4%)TV-MI,and 0(0%)TLR compositely.Furthermore,late stent thrombosis was found in 2(0.4%)patients at the follow-up of 12-mo,very late stent thrombosis was observed in 2 patients(0.4%)at 3-year follow-up.CONCLUSION FlexyRap®DES was proved to be safe and efficacious in real-world patients with de novo CAD,indicating a lowered rate of cardiac events and stent thrombosis at 5-year follow-up.
文摘目的运用Meta分析评价涂层可生物降解药物洗脱支架(BP-SES)在小血管介入中的疗效。方法检索知网、维普、万方、SinoMed、Embase、PubMed、Cochrane Library、Web of Science数据库,搜集BP-SES治疗小血管病变的随机对照实验,时间为建库起至2022年8月15日,采用Revman 5.4.1软件进行Meta分析。结果共纳入5项RCTs,共4248例患者,结果显示:BP-SES在改善大、小血管病变支架内再狭窄[RR=0.77,95%CI(0.31,1.90),P=0.58]、支架内血栓[RR=1.34,95%CI(0.54,3.37),P=0.53]、靶血管血运重建[RR=1.18,95%CI(0.80,1.74),P=0.39]、全因死亡[RR=1.25,95%CI(0.85,1.83),P=0.26]、心因性死亡[RR=1.62,95%CI(0.54,4.86),P=0.39]、非致死性心梗[RR=1.28,95%CI(0.84,1.93),P=0.25]和MACE事件[RR=1.42,95%CI(0.91,2.21),P=0.12]发生率差别不具有统计学意义。结论BP-SES治疗冠状动脉小血管病变的有效性和安全性与大血管相近,可以在临床上应用。
