Antonio Colombo1, Jaya Chandrasekhar2, Melissa Aquino2, Tiong Kiam Ong3, Samantha Sartori2, Usman Baber2, Michael Lee4, Andres Iniguez5, Petr Hajek6, Borislav Borisov7, Borislav Atzev8, Peter Den Heijer9, Zdenek Coufal10, Martin Hudec11, Martin Mates12, Clayton Snyder2, Kamilia Moalem2, Deborah Morrell13, Francesca Elmore13, Stephen Rowland13, Roxana Mehran14. 1. San Raffaele Scientific Institute, Milan, Italy. 2. Icahn School of Medicine at Mount Sinai, New York, NY, USA. 3. Pusat Jantung Hospital Umum Sarawak, Sarawak, Malaysia. 4. Queen Elizabeth Hospital, Singapore. 5. Meixoeiro Hospital - University Hospital of Vigo, Vigo, Spain. 6. 2nd Faculty of Medicine and Motol University Hospital, Praha, Czech Republic. 7. MBAL St. Ivan Rilski, Stara Zagora, Bulgaria. 8. MBAL Puls, Blagoevgrad, Blagoevgrad, Bulgaria. 9. Amphia Hospital - Breda, Breda, Netherlands. 10. T. Bata Regional Hospital Zlin, Zlin, Czech Republic. 11. SuSCH Banská Bystrica, Banská Bystrica, Slovakia. 12. Nemocnice na Homolce, Praha 5, Czech Republic. 13. OrbusNeich Ltd, Fort Lauderdale, FL, USA. 14. Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: Roxana.mehran@mountsinai.org.
Abstract
BACKGROUND: The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization. METHODS: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization. RESULTS: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12). CONCLUSION: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS. GOV IDENTIFIER: NCT02183454.
BACKGROUND: The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization. METHODS: The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization. RESULTS: A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12). CONCLUSION: The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS. GOV IDENTIFIER: NCT02183454.
Authors: Jaya Chandrasekhar; Usman Baber; Samantha Sartori; Melissa B Aquino; Petr Hájek; Borislav Atzev; Martin Hudec; Tiong Kiam Ong; Martin Mates; Borislav Borisov; Hazem M Warda; Peter den Heijer; Jaroslaw Wojcik; Andres Iniguez; Zdeněk Coufal; Ahmed Khashaba; Muhammad Munawar; Robert T Gerber; Bryan P Yan; Paula Tejedor; Petr Kala; Houng Bang Liew; Michael Lee; Deborah N Kalkman; George D Dangas; Robbert J de Winter; Antonio Colombo; Roxana Mehran Journal: Int J Cardiol Heart Vasc Date: 2020-09-06