Jaya Chandrasekhar1,2, Vera C de Winter2, Deborah N Kalkman2, Samantha Sartori1, Rishi Chandiramani1, Melissa B Aquino1, Puk de Wilde2, Doreen Zeebregts2, Pier Woudstra2, Marcel A Beijk2, Petr Hájek3, Borislav Atzev4, Martin Hudec5, Tiong Kiam Ong6, Martin Mates7, Borislav Borisov8, Hazem M Warda9, Peter den Heijer10, Jaroslaw Wojcik11, Andres Iniguez12, Zdeněk Coufal13, Michael Lee14, Jan G Tijssen2, Karel T Koch2, Usman Baber1, George D Dangas1, Antonio Colombo15, Robbert J de Winter2, Roxana Mehran16,17. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital, New York, USA. 2. Department of Clinical and Experimental Cardiology, Amsterdam UMC, Heart Center, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. 3. Department of Cardiology, Motol University Hospital, Prague, Czech Republic. 4. Department of Cardiology, University Hospital St. Ekaterina, Sofia, Bulgaria. 5. Department of Cardiology, SUSCCH, a.s. Banska Bystrica, Banska Bystrica, Slovakia. 6. Department of Cardiology, Sarawak Heart Centre, Kota Samarahan, Sarawak, Malaysia. 7. Department of Cardiology, Nemocnice na Homolce - Kardiologie, Prague, Czech Republic. 8. Department of Cardiology, MBAL St. Ivan Rilski, Dupnitsa, Bulgaria. 9. Department of Cardiology, Alhyatt Cardiovascular Center, Alexandria, and Tanta University Hospital, Tanta, Egypt. 10. Department of Cardiology, Breda Amphia, Breda, Netherlands. 11. Hospital of Invasive Cardiology IKARDIA, Nałęczów, Lublin, Poland. 12. Department of Cardiology, Hospital Álvaro Cunqueiro, Vigo, Spain. 13. Department of Cardiology, T. Bata Regional Hospital Zlin, Zlin, Czech Republic. 14. Department of Cardiology, Queen Elizabeth Hospital, Kowloon, Hong Kong. 15. Department of Cardiology, San Raffaele Hospital, Milan, Italy. 16. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital, New York, USA. roxana.mehran@mountsinai.org. 17. Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, NY, 10029, USA. roxana.mehran@mountsinai.org.
Abstract
PURPOSE: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). RESULTS: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. CONCLUSIONS: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.
PURPOSE: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). RESULTS: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. CONCLUSIONS: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.