Prospective rAndomized, single-blind, mulTicenter study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-eluting cOronary stenT “XiencePrime”: results of the PATRIOT trial

Abstract

Aim. This trial was aimed at comparing the efficacy and safety of sirolimus-eluting coronary stent “Calypso” (Angioline) and everolimus-eluting coronary stent “XiencePrime” (Abbott Vascular) when used for treatment of ischemic heart disease patients.Methods. The trial included patients suitable for coronary revascularization with coronary stenting. They underwent a standard revascularization procedure and were randomized in 2:1 ratio to receive “Calypso” coronary stent (Angioline) (n = 407) or “XiencePrime” coronary stent (AbbottVascular) (n = 203). The follow-up period was 12 months. In order to detect restenosis (secondary endpoint), angiographic follow-up was performed in 20% of cases at 12 months. The trial protocol had no limitations regarding the length of lesions, number of target lesions and number of implanted stents. The main exclusion criterion was STEMI. The composite primary endpoint included one-year target lesion-related complications determined as cardiogenic death, target vessel myocardial infarction, clinically indicated target lesion revascularization. The primary endpoint data were evaluated by an independent committee.Results. In the trial, 55% of patients had acute coronary syndrome with ST elevation and type C lesions were detected in 46% of cases. In “Calypso” and “XiencePrime” groups, TLF occurred in 5.4% and 6.4% respectively (absolute risk difference in TLF accounted for 1%, 95% CI [---;2.1%]; p non-inferiority = 0.017). Thus, the hypothesis of non-inferiority of “Calypso” as compared to “XiencePrime” was confirmed. The incidence of stent thrombosis (definite and probable) was relatively low and had no significant differences between “Calypso” and “XiencePrime” groups (0.73% and 0%; p>0.05). Definite stent thrombosis was noted in two cases in the “Calypso” group (0.49%), in one case the cause of thrombosis turned out to be incomplete stent expansion after implantation.Conclusion. “Calypso” sirolimus eluting stent was not inferior to “XiencePrime” everolimus-eluting stent in treating patients with coronary heart disease.Received 7 November 2017. Revised 13 November 2017. Accepted 20 November 2017.Funding: The study was funded by “Angioline Interventional Devices” (Novosibirsk, Russian Federation). The supporting source had no involvement in study design; collection, analysis and interpretation of data; writing of the report; and in the decision to submit the article for publication.Conflict of interest: The authors declare no conflict of interest.

Keywords

• коронарный стент
• рандомизированное исследование
• «Калипсо»
• ишемическая болезнь сердца