The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

BioMatrix versus Orsiro Stent for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study

DOI: 10.4244/EIJ-D-20-00185

1. Seoul National University Bundang Hospital, Seongnam, Rebublic of Korea
2. Sejong General Hospital, Bucheon, Republic of Korea
3. Catholic Kwandong University International St. Mary’s Hospital, Incheon, Republic of Korea
4. Pusan National University Hospital, Pusan, Republic of Korea
5. Wonju Severance Hospital, Yonsei University College of Medicine, Republic of Korea
6. Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
7. Korea University Guro Hospital, Seoul, Republic of Korea
8. Gachon University Gil Medical Center, Incheon, Republic of Korea
9. Chungnam National University Hospital, Daejeon, Republic of Korea
10. Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea
11. Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea, Republic of
12. KEPCO Medical Center, Seoul, Korea, Republic of
13. Kyoungpook National University hospital, Daegu, Korea, Republic of
14. Inje University Paik Hospital, Pusan, Korea, Republic of
15. The Catholic University of St,Mary’s Hospital, Bucheon, Korea, Republic of
16. Cha University Bundang Cha Medical Center, Seongnam, Korea, Republic of
17. Myongji Hospital, Govangsi, Korea, Republic of
18. Kosin University Gospel Hopital, Pusan, Korea, Republic of
19. The Catholic University of St,Paul’s Hospital, Bucheon, Korea, Republic of
20. Kangwon National University Hospital, Chuncheon, Korea, Republic of
21. Dankook University Hospital, Cheonan, Korea, Republic of
22. The Catholic University of St,Mary’s Hospital, Uijeongbu, Korea, Republic of
23. Yongnam University Medical center, Daegu, Korea, Republic of
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Aims
To compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt–chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix).

Methods and Results
This randomized, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF),. Between 21st July 2014 and 28th September 2017, we randomly assigned 2341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175). We analysed 2327 patients who finished 18-month follow-up. The mean patient age was 63.5 years, and 1565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio: 0.70, upper limit of one-sided 95% confidence interval: 1.18, P for non-inferiority <0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs. 12 [1.0%], P=0.558), target lesion-related myocardial infarction (0 [0%] vs. 3 [0.3%], P = 0.250), target lesion revascularization (18 [1.6%] vs. 10 [0.9%], P=0.124), or stent thrombosis (0 [0%] vs. 2 [0.2%], P=0.50).

Conclusion
In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed excellent clinical outcomes.

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