机构：[1]General Hospital of Shenyang Military Region, Shenyang, China[2]Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China[3]Daqing Oilfield General Hospital, Daqing, China[4]The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China[5]Xijing Hospital of The Fourth Military Medical University, Xi’an, China[6]Tangdu Hospital of The Fourth Military Medical University, Xi’an, China[7]The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China[8]Chinese People’s Armed Police Force General Hospital, Beijing, China[9]Affiliated Anzhen Hospital of Capital Medical University, Beijing, China首都医科大学附属安贞医院[10]First Hospital of Shanxi Medical University, Taiyuan, China[11]Zhongda Hospital Southeast University, Nanjing, China[12]Affiliated Sir Run Run Shaw Hospital of Zhejiang University, Hangzhou, China[13]Shengjing Hospital of China Medical University, Shenyang, China中国医科大学盛京医院[14]Hebei Ceneral Hospital, Shijiazhuang, China[15]The 306th Hospital of PLA, Beijing, China[16]The 254th Hospital of PLA, Tianjin, China
Aims: We performed a multicenter, randomized controlled trial to determine the noninferiority of a novel biodegradable polymer drug-eluting stent (BP-DES), the EXCEL 2 stent, to the first-generation BP-DES, the EXCEL stent. Methods and Results: Patients (n=419) scheduled to undergo percutaneous coronary intervention (PCI) were randomized to receive either the EXCEL 2 stent (n = 208) or the EXCEL stent (n = 211) from 15 Chinese centers. At 9months, primary endpoint in-stent late loss (LL) difference was-0.03mm (95% confidence interval: -0.09mm to 0.04mm) between the EXCEL 2 group (0.140 +/- 26mm) and the EXCEL group (0.160 +/- 36mm), demonstrating the noninferiority of EXCEL 2 to EXCEL in terms of in-stent LL (P for noninferiority < .0001). Besides, target lesion failure (TLF) was statistically lower in EXCEL 2 group compared with EXCEL through 1year (HR [95%CI] = 0.45 [0.20,0.98], Plog-rank = .04). Definite/probable ST was observed in 0.0% vs 1.9% (P = .12) of EXCEL 2 vs EXCEL-treated subjects. Conclusions: The second-generation BP-DES (EXCEL 2) was noninferior to the first-generation BP-DES (EXCEL) for the primary endpoint of in-stent LL at 9months.
基金：
National Key Project of Research and Development Plan during the Thirteenth Five-year Plan Period, China [2016YFC1301300]
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2017]版：
大类|3 区医学
小类|3 区药学4 区心脏和心血管系统
最新[2023]版：
大类|4 区医学
小类|3 区药学4 区心脏和心血管系统
JCR分区：
出版当年[2016]版：
Q2PHARMACOLOGY & PHARMACYQ2CARDIAC & CARDIOVASCULAR SYSTEMS
第一作者机构：[1]General Hospital of Shenyang Military Region, Shenyang, China
共同第一作者：
通讯作者：
通讯机构：[1]General Hospital of Shenyang Military Region, Shenyang, China[*1]Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
推荐引用方式(GB/T 7714)：
Kai Xu,Yaling Han,Bo Xu,et al.Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial[J].CARDIOVASCULAR THERAPEUTICS.2018,36(3):-.doi:10.1111/1755-5922.12327.
APA：
Kai Xu,Yaling Han,Bo Xu,Yuejin Yang,Geng Wang...&Kui Pu.(2018).Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial.CARDIOVASCULAR THERAPEUTICS,36,(3)
MLA：
Kai Xu,et al."Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial".CARDIOVASCULAR THERAPEUTICS 36..3(2018):-
