Ten-year outcomes of the russian drug-eluting stent Calypso in patients with acute coronary syndrome: data from a prospective multicenter study

Objective – to evaluate the long-term (10-year) safety and efficacy outcomes of the domestic sirolimus-eluting stent Calypso compared with the Xience Prime stent in patients with acute coronary syndrome (ACS) under real-world clinical conditions. Material and methods . A total of 274 patients with ACS were initially enrolled in this prospective multicenter study. Patients were divided into two groups: the first group included 140 patients who received the Calypso stent, and the second group included 134 patients who received the Xience Prime stent. At the 10-year follow-up, complete data were available for 191 patients (69.7 %): 98 in the Calypso group and 93 in the Xience Prime group. The primary endpoint was the composite rate of major adverse cardiac events (MACE). Results . Over the 10-year follow-up period, the incidence of MACE was 31.6 % in the Calypso group versus 34.4 % in the Xience Prime group (hazard ratio [HR] 0.91; 95 % confidence interval [CI] 0.58–1.43; p = 0.68). No statistically significant differences were observed between groups in any individual MACE components. The rate of restenosis requiring repeat stenting was 4.1 % and 7.5 % in the Calypso and Xience Prime groups, respectively (p = 0.29). Conclusions . The Calypso sirolimus-eluting stent demonstrates long-term clinical efficacy and safety comparable to those of the Xience Prime stent in patients with acute coronary syndrome.