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

Autor: 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
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Cardiology Discovery, Vol 3, Iss 1, Pp 1-8 (2023)
Druh dokumentu: article
ISSN: 2096-952X
00000000
DOI: 10.1097/CD9.0000000000000067
Popis: 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
Databáze: Directory of Open Access Journals
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