A Randomized Controlled Trial of a Biodegradable Polymer,Microcrystalline Sirolimus-Eluting Stent(MiStent)versus Another Biodegradable Polymer Sirolimus-Eluting Stent(TIVOLI):The DESSOLVE-C Trial  

作　　者：Bin Wang Sicong Ma Zhiyong Wang Li Zhang Hanjun Pei Yang Zheng Yuejin Yang Zheng Zhang Xinqun Hu Ziwen Ren Feng Zhang Changqian Wang Renqiang Yang Zhiming Yang Yuexi Wang Guosheng Fu Yu Cao Zuyi Yuan Kai Xu Xin Zhao Bo Xu Miaohan Qiu Quanmin Jing 

机构地区：[1]Department of Cardiology,General Hospital of Northern Theater Command,Shenyang,Liaoning 110015,China [2]Department of Cardiology,People’s Hospital of Inner Mongolia Autonomous Region,Hohhot,Inner Mongolia 010017,China [3]Department of Cardiology,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China [4]Department of Cardiology,The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology,Baotou,Inner Mongolia 014000,China [5]Department of Cardiology,The First Clinical Hospital of Jilin University,Changchun,Jilin 130021,China [6]Department of Cardiology,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China [7]Department of Cardiology,The First Hospital of Lanzhou University,Lanzhou,Gansu 730000,China [8]Department of Cardiology,Second Xiangya Hospital of Central South University,Changsha,Hunan 410011,China [9]Department of Cardiology,TEDA International Cardiovascular Hospital,Tianjin 300457,China [10]Department of Cardiology,Shanghai Ninth People’s Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 201999,China [11]Department of Cardiology,Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi 330000,China [12]Department of Cardiology,Second Hospital of Shanxi Medical University,Taiyuan,Shanxi 031100,China [13]Department of Cardiology,Affiliated Hospital of Inner Mongolia Medical University,Hohhot,Inner Mongolia 010110,China [14]Department of Cardiology,School of Medicine,Sir Run Run Shaw Hospital,Biomedical Research Center,Zhejiang University,Hangzhou,Zhejiang 310016,China [15]Department of Cardiology,Third Xiangya Hospital,Central South University,Changsha,Hunan 410013,China [16]Department of Cardiology,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an,Shaanxi 710061,China

出　　处：《Cardiology Discovery》2023年第1期1-8,共8页心血管病探索（英文）

摘　　要：Objective::Data comparing the outcomes of MiStent(Micell Technologies,Durham,North Carolina,USA)microcrystalline biodegradable polymer(BP)drug-eluting stent(DES)and those of another post-marketing BP-DES,TIVOLI(EssenTech,Beijing,China)are rare.This study sought to compare the angiographic efficacy and clinical outcomes of the microcrystalline BP sirolimus-eluting stent(SES)system MiStent and those of TIVOLI BP-SES.Methods::The DESSOLVE-C trial was a prospective,single-blinded,multicenter,randomized trial(NCT02448524),which randomly assigned patients with de novo coronary lesions to receive MiStent or TIVOLI BP-SES by a 1:1 ratio.The primary endpoint was a non-inferiority comparison of in-stent late lumen loss(LLL)by quantitative coronary angiography at 9 months.The secondary endpoint was device-related clinical cardiovascular composite events(target lesion failure(TLF),composite of cardiac death,target vessel myocardial infarction(MI),and clinically driven target lesion revascularization)and 1-year outcomes.Results::A total of 428 patients(216 patients in the MiStent group and 212 patients in the TIVOLI group)were enrolled and included in an intention-to-treat analysis.MiStent was not only non-inferior but superior to TIVOLI for in-stent LLL at 9 months((0.23±0.37)mm vs.(0.34±0.48)mm,P for non-inferiority<0.001,P for superiority=0.02).Although without significant difference,the rate of TLF in MiStent was quantitatively lower than that in TIVOLI(3.70%vs.6.60%;P=0.17).Conclusion::Compared with TIVOLI BP-SES,the MiStent system was superior in in-stent LLL at 9 months and had a comparable clinical benefit at 1 year in de novo coronary lesions.

关 键 词：DRUG-ELUTING STENTS MiStent MICROCRYSTALLINE Biodegradable polymer Sirolimus-eluting stent de novo coronary lesion 

分 类 号：R541.4[医药卫生—心血管疾病]