Long term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years |
| |
作者单位: | ZHANG Qi,ZHANG Rui-yan,ZHANG Jian-sheng,HU Jian,SHEN Wei-feng(Department of Cardiology,Ruijin Hospital,Shanghai Jiao tong University School of Medicine,Shanghai 200025,China);XU Bo,YANG Yue-jin,QIAO Shu-bin,QIN Xue-wen,CHEN Ji-lin,GAO Run-lin(Department of Cardiology,Cardiovascular Institute and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China) |
| |
基金项目: | The first two authors contributed equally to this article. |
| |
摘 要: | Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent (SES) in coronary artery disease. Methods The sample was 509 consecutive patients with coronary artery disease (CAD) who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events (MACE) and Academic Research Consortium defined stent thrombosis (ST) were evaluated in patients with and without diabetes mellitus. Results Three hundred and thirty three patients (65. 4%) were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year's and 3 years' clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE (13.7% vs 6.4%, P 〈0.05) and TVR (9.8% vs 4.0%, P 〈0.05) and the cumulative MACE free survival rate was very significantly lower in the DM group (86.4% vs 93;6%, P 〈0.05). ST occurred in 7 patients (1.4%) at the end of 3 years' follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label (1.5%) and on label groups (1.1%, P=-0.07). Conclusions In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.
|
关 键 词: | 冠状动脉疾病 展幅机 临床研究 治疗措施 |
Long term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years |
| |
Authors: | ZHANG Qi XU Bo YANG Yue-jin QIAO Shu-bin ZHANG Rui-yan ZHANG Jian-sheng HU Jian QIN Xue-wen CHEN Ji-lin SHEN Wei-feng GAO Run-lin |
| |
Institution: | 1. Department of Cardiology,Ruijin Hospital,Shanghai Jiao tong University School of Medicine,Shanghai 200025,China 2. Department of Cardiology,Cardiovascular Institute and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China |
| |
Abstract: | Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient.We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent (SES) in coronary artery disease.Methods The sample was 509 consecutive patients with coronary artery disease (CAD) who were treated by Firebird SES and finished three-year clinical follow-up.The occurrences of major adverse cardiac events (MACE) and Academic Research Consortium defined stent thrombosis (ST) were evaluated in patients with and without diabetes mellitus.Results Three hundred and thirty three patients (65.4%) were treated by Firebird SES by off label indications.Angiographic success was achieved in 98.3% of the lesions.MACE and target vessel revascularization rates at 6-month,1 year's and 3 years' clinical follow-up were 2.4% and 1.4%,4.1% and 2.8%,7.9% and 5.1%,respectively.The cumulative 3-year MACE free survival rate was 92.1%.After 3 years,DM patients had significantly higher rates of MACE (13.7% vs 6.4%,P<0.05) and TVR (9.8% vs 4.0%,P<0.05) and the cumulative MACE free survival rate was very significantly lower in the DM group (86.4% vs 93:6%,P<0.05).ST occurred in 7 patients (1.4%) at the end of 3 years' follow-up,5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina,the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up.There was no difference in occurrence of ST between off label (1.5%) and on label groups (1.1%,P=0.07).Conclusions In daily practice,about 2/3 of patients were treated by Firebird SES by off label indications.Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate.DM patients had higher rates of adverse events and than non DM. |
| |
Keywords: | coronary artery disease sirolimus stent off label outcomes |
本文献已被 维普 万方数据 等数据库收录! |
| 点击此处可从《中华医学杂志(英文版)》浏览原始摘要信息 |
| 点击此处可从《中华医学杂志(英文版)》下载免费的PDF全文 |
|