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.
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Data Availability
Data requests will be reviewed by the study Steering Committee.
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Acknowledgments
We thank all the research participants and site researchers for their contributions.
Funding
The Academic Medical Center received an unrestricted research grant from OrbusNeich Medical BV (Hoevelaken, The Netherlands). OrbusNeich Medical (Ft.Lauderdale, Florida, USA) is the sponsor of the MASCOT registry.
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Conflict of Interest
Dr. Mehran has received institutional research grant support from Eli Lilly/Daiichi-Sankyo Inc., AstraZeneca, The Medicines Company, Bristol-Myers Squibb, OrbusNeich, Beth Israel Deaconess, and Bayer; has served as a consultant for Boston Scientific, Cardiovascular Systems Inc., Medscape, and Shanghai BraccoSine Pharmaceutical; has received institutional advisory board funding from Bristol-Myers Squibb; has received institutional funding from Claret Medical; owns equity in Claret Medical and Elixir Medical; has served on the executive committee for Janssen Pharmaceuticals and Osprey Medical; has served on the data safety monitoring board for Watermark Research Partners; and has a spouse who has served as a consultant for Abiomed and the Medicines Company. All the other authors have no relevant disclosures.
Ethics Approval
All participating sites obtained ethics approval or waiver to undertake the MASCOT or REMEDEE registry.
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All patients provided informed consent for inclusion in the study.
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Consent to analyze deidentified data and publish the results obtained.
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Clinicaltrials.gov Identifiers
NCT01874002 for REMEDEE registry, NCT02183454 for MASCOT registry.
Appendix
Appendix
MASCOT investigators
Steering Committee
Antonio Colombo, MD (Principal Investigator)
Roxana Mehran, MD
Tiong Kiam Ong, MD
Michael Lee, MD
Andres Iniguez, MD, PhD
Stephen Rowland, PhD
Clinical events committee
Newsha Ghodsi, MD (Chair)
Steven Marx, MD
Douglas DiStefano, MD
Jesse Weinberger, MD
Shing Chiu Wong, MD
Bruce Darrow, MD
David Kaufman, MD
Mark Milstein, MD
Clinical coordinating center
Roxana Mehran, MD (Director)
Jaya Chandrasekhar, MBBS, MS, PhD
Usman Baber, MD, MS
Melissa Aquino, MS
Samantha Sartori, PhD
Clayton Snyder, BS
Theresa Franklin-Bond, PA, MS
Jin Young Cha, BSc.
Lynn Vandertie
Emma Whittaker
Kate Allen
Birgit Vogel, MD
Serdar Farhan, MD
Sabato Sorrentino, MD, PhD
Zhen Ge, MD
Site investigators
Marc Carlier, MD
Suzanne Pourbaix, MD
Borislav Borisov, MD
Borislav Atzev, MD
Dobrin Vasilev, MD
Christos Christou, MD
Ladislav Pešl, MD
Zdeněk Coufal, MD
Petr Kala, MD and Petr Jeřábek, MD
Petr Hájek, MD, Ph.D
Alexander Schee, MD and Roman Ondrejcak, MD
Vladimír Rozsíval, MD and Jan Matějka, MD
Martin Mates, MD
Ahmed Khashaba, MD
Hazem Warda, MD
Sulev Margus, MD
Bryan Yan, MD
Cheuk Sum Lam, MD
Tak Sun Chung, MD
Li Wah Tam, MD
Alan Ka Chun Chan, MD
Ping Tim Tsui, MD
Kin Lam Tsui, MD
Teguh Santoso, MD
Muhammad Munawar, MD
Muhammad Syukri, MD
Dasdo Antonius Sinaga, MD
Alessandro Lupi, MD
Carlo Briguori, MD
Antonio Colombo, MD
Oteh Maskon, MD
Tiong Kiam Ong, MD
Sazzli Kazim, MD
Chuey Yan Lee, MD
Houng Bang Liew, MD
Rosli Mohammad Ali, MD
Ramesh Singh, MD
Peter Den Heijer, MD
Jaroslaw Wojcik, MD
Vladan Vukčević, MD
Martin Hudec, MD
Anton Farkaš, MD
Stanislav Juhás, MD and Monika Jankajová, MD
Milan Dragula, MD
Carlos Cuellas Ramon, MD
Andres Iniguez, MD, PhD
Paula Tejedor, MD
Fernando Lozano Ruiz-Poveda, MD
Alfonso Torres Bosco, MD
Essia Boughzela, MD and Medhi Slim, MD
Habib Haouala, MD and Dhaker Lahidheb, MD
Mohamed Rachid Boujnah, MD
Grahame K. Goode, MD
Sukhbir Dhamrait, MD
Robert Gerber, MD
Piers Clifford, MD
Timothy Kinnaird, MD
Gabriel Varnagy, MD
Pedro J. Aguiar R., MD
Thuong Van Huynh, MD
REMEDEE registry investigators
Ian B Menown, MD
Peter den Heijer, MD, PhD
Arnoud WJ van't Hof, MD, PhD
Andrejs Erglis, MD
Harry Suryapranata, MD, PhD
Karin E Arkenbout, MD, PhD
Andrés Iñiguez, MD, PhD
Philippe Muller, MD
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Chandrasekhar, J., de Winter, V.C., Kalkman, D.N. et al. One-Year COMBO Stent Outcomes in Acute Coronary Syndrome: from the COMBO Collaboration. Cardiovasc Drugs Ther 35, 309–320 (2021). https://doi.org/10.1007/s10557-020-07087-6
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DOI: https://doi.org/10.1007/s10557-020-07087-6