Author + information
- Antonio Colombo1,
- Stephen Rowland2,
- Jaya Chandrasekhar3,
- Tiong Kiam Ong4,
- Michael Lee5,
- Clayton Snyder3,
- Melissa Aquino6,
- Debbie Morrell7,
- Francesca Elmore7 and
- Roxana Mehran8
- 1San Raffaele Scientific Institute, Milan, Italy
- 2OrbusNeich Medical, Fort Lauderdale, Florida, United States
- 3Icahn School of Medicine at Mount Sinai, New York, New York, United States
- 4Sarawak General Hospital Heart Centre, Kota Samarahan, Malaysia
- 5Department of Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong
- 6Mount Sinai Medical Center, New York, New York, United States
- 7OrbusNeich, Fort Lauderdale, Florida, United States
- 8Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, New York, United States
The Combo stent (OrbusNeich Medical, Ft.Lauderdale, Florida) is a new generation bio-engineered drug eluting stent which combines an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus, with a luminal anti-CD34 coating for endothelial progenitor cell capture to promote rapid endothelialization. The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) post-marketing registry evaluated the 1-year efficacy and safety outcomes of the Combo stent in an all-comers population undergoing percutaneous coronary intervention (PCI).
MASCOT was a multicenter, prospective all-comers post-marketing study conducted from June 2014-May 2017 across 61 centers in Europe, Middle East, Asia and South America. Patients were eligible if Combo stent implantation was attempted. Follow up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events as well as adherence profile. Patients received dual antiplatelet therapy (DAPT) as per local guidelines. The primary endpoint was target lesion failure, defined as a composite of cardiac death, non-fatal myocardial infarction not attributable to a non-target vessel, or ischemia-driven target lesion revascularization by PCI or coronary artery bypass surgery.
A total of 2615 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 22.9% were female. History of diabetes mellitus was present in 33.5%, prior PCI in 25.5% and atrial fibrillation or flutter in 6.9%. A total of 56.2% patients underwent PCI for ACS. Multivessel disease was present in 51.9% patients and 9.8% had significant left main disease. Of the 3191 treated lesions, 56.0% were American Heart Association type B2 or C lesions. The 1-year clinical outcomes will be available at the time of presentation.
The MASCOT Post marketing registry will provide comprehensive safety, efficacy, and adherence to DAPT outcomes following contemporary PCI using the novel Combo stent in an all-comer population (Clinicaltrials.gov identifier NCT02183454).
CORONARY: Stents: Drug-Eluting