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
10.1097/CD9.0000000000000067
- VernacularTitle: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
- Author:
Bin WANG
1
;
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
Author Information
1. Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110015, China
- Publication Type:Journal Article
- Keywords:
Drug-eluting stents;
MiStent;
Microcrystalline;
Biodegradable polymer;
Sirolimus-eluting stent;
de novo coronary lesion
- From:
Cardiology Discovery
2023;03(1):1-8
- CountryChina
- Language:English
-
Abstract:
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.
