Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial

• Published in: Circulation. Cardiovascular interventions Vol. 13; no. 6; p. e008737
• Main Authors: Takahashi, Kuniaki, Serruys, Patrick W., Kogame, Norihiro, Buszman, Paweł, Lurz, Philipp, Jessurun, Gillian A.J., Koch, Karel T., Troquay, Roland P.T., Hamer, B.J.B, Oude Ophuis, Ton, Milewski, Krzysztof P., Hofma, Sjoerd H., Wykrzykowska, Joanna J., Onuma, Yoshinobu, de Winter, Robbert J., Wijns, William
• Format: Journal Article
• Language: English
• Published: United States American Heart Association, Inc 01.06.2020
• Subjects: percutaneous coronary intervention; drug-eluting stents; sirolimus-eluting stents; biodegradable polymer
• ISSN: 1941-7632; 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.119.008737

Numerous randomized clinical trials have demonstrated the superiority of thin-strut biodegradable polymer second-generation drug-eluting stent to the first-generation drug-eluting stent and the noninferiority to the thin-strut second-generation permanent polymer drug-eluting stent. Data on long-term clinical outcomes with a novel ultrathin drug-eluting stent, to date, are limited. The DESSOLVE III trial (Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System for Revascularization of Coronary Arteries; n=1398) is a prospective, multicenter, single-blinded, all-comers, randomized controlled trial (NCT02385279), allocating in a 1:1 ratio to either ultrathin-strut biodegradable polymer MiStent sirolimus-eluting stent or to thin-strut permanent polymer Xience everolimus-eluting stent. The primary end point was device-oriented composite end point, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. The secondary end point was patient-oriented composite end point, defined as the composite of all-cause mortality, any myocardial infarction, or any revascularization. At 3 years, follow-up data were available in 1381 patients (98.8%). The primary end point of device-oriented composite end point occurred in 10.5% for MiStent sirolimus-eluting stent and in 11.5% for Xience everolimus-eluting stent ( =0.55). Rates of cardiac death (3.9% versus 3.8%; =0.88), target vessel myocardial infarction (3.2% versus 2.5%; =0.43), and clinically indicated target lesion revascularization (5.2% versus 6.5%; =0.30) did not differ significantly between the 2 devices. The rate of definite or probable stent thrombosis was infrequent and similar between the 2 arms (1.2% versus 1.5%; =0.64). The 90-day landmark analysis showed no significant difference in device-oriented composite end point between the 2 groups after polymer degradation of MiStent. The risk of patient-oriented composite end point was comparable between the 2 groups (22.7% versus 22.9%; =0.34). In the DESSOLVE III trial, early safety and efficacy with MiStent sirolimus-eluting bioabsorbable polymer-coated stent are confirmed at a longer term follow-up when compared with Xience everolimus-eluting permanent polymer-coated stent in a large all-comers population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02385279.