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

https://doi.org/10.52727/2078-256X-2025-21-4-394-400

Abstract

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.

About the Authors

M. V. Chernyaev
RUDN University; FGBU “NMIC TPM” of the Ministry of Health of Russia
Russian Federation

Mikhail V. Chernyaev, candidate of medical scinces, associate professor of the department of hospital surgery with a course in pediatric surgery at the medical institute

6, Miklukho-Maklaya st., Moscow, 117198;

endovascular surgery

10, Bldg. 3, Petroverigsky Lane, Moscow, 101990



A. I. Zagorulko
State Budgetary Healthcare Institution, Oncology Center No. 1, City Clinical Hospital named after S.S. Yudin; RUDN University
Russian Federation

Alexei I. Zagorulko, сandidate of medical sciences, head of the department of X-ray surgical methods of diagnostics and treatment No. 2

18A, Zagorodnoe sh., Moscow, 117152;

physician in X-ray endovascular diagnostics and treatment, cardiovascular surgeon, assistant of the department of cardiology, X-ray endovascular and hybrid methods of diagnostics and treatment

6, Miklukho-Maklaya st., Moscow, 117198



A. A. Logunova
RUDN University
Russian Federation

Anastasiya A. Logunova

6, Miklukho-Maklaya st., Moscow, 117198



V. A. Mityashina
RUDN University
Russian Federation

Viktoria A. Mityashina

6, Miklukho-Maklaya st., Moscow, 117198



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Chernyaev M.V., Zagorulko A.I., Logunova A.A., Mityashina V.A. Ten-year outcomes of the russian drug-eluting stent Calypso in patients with acute coronary syndrome: data from a prospective multicenter study. Ateroscleroz. 2025;21(4):394-400. (In Russ.) https://doi.org/10.52727/2078-256X-2025-21-4-394-400

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ISSN 2078-256X (Print)
ISSN 2949-3633 (Online)