Prospective rAndomized, single-blind, mulTicenter control clinical study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-elutIng cOronary stenT “Xience Prime”: design and rationale for “PATRIOT” trial

Abstract

&lt;p&gt;&lt;strong&gt;Aim.&lt;/strong&gt; This study is aimed at evaluating the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease. &lt;br /&gt;&lt;strong&gt;Methods.&lt;/strong&gt; This is a prospective, randomized, single-blind multicenter clinical trial in patients undergoing coronary revascularization with coronary stenting. Seven clinical sites in Russia will enroll 610 patients with coronary artery disease. Patients suitable for coronary stenting will be randomized in group 1 (n=406) to receive coronary stent “Calypso” (“Angioline”, and group 2 (n=204) to receive coronary stent Xience Prime (Abbott). Clinical follow-up will continue for 1 year. By the end of follow-up, a quantitative coronary angiography will be performed in 122 patients (20 %). &lt;br /&gt;&lt;strong&gt;Conclusion.&lt;/strong&gt; A randomized trial “PATRIOT” is designed to prove the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease.&lt;/p&gt;&lt;p&gt;Received 5 October 2016. Accepted 6 December 2016.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Funding:&lt;/strong&gt; This study was funded by “Angioline Interventional Devices”, 630090, 18 Inzhenernaya Street, Novosibirsk, Russian Federation. &lt;br /&gt;&lt;strong&gt;Conflict of interest:&lt;/strong&gt; The authors declare no conflict of interest.&lt;/p&gt;</jats:p