Author + information
- Received February 26, 2018
- Revision received March 21, 2018
- Accepted April 21, 2018
- Published online October 1, 2018.
- Robbert J. de Winter, MD, PhDa,
- Jaya Chandrasekhar, MBBS, MSb,
- Deborah N. Kalkman, MD, PhDa,b,
- Melissa B. Aquino, MSb,
- Pier Woudstra, MDa,
- Marcel A. Beijk, MD, PhDa,
- Samantha Sartori, PhDb,
- Usman Baber, MD, MSb,
- Jan G. Tijssen, PhDa,
- Karel T. Koch, MD, PhDa,
- George D. Dangas, MD, PhDb,
- Antonio Colombo, MDc,
- Roxana Mehran, MDb,∗ (, )
- on behalf of the MASCOT,
- REMEDEE Registry Investigators
- aDepartment of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- bDepartment of Cardiology, Icahn School of Medicine at Mount Sinai Hospital, New York, New York
- cDepartment of Cardiology, San Raffaele Hospital, Milan, Italy
- ↵∗Address for correspondence:
Dr. Roxana Mehran, Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
Objectives The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort.
Background The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization.
Methods The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF.
Results A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF.
Conclusions In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002)
- drug-eluting stent(s)
- endothelial progenitor cell anti-CD34+ antibody
- percutaneous coronary intervention
- stent healing
The Academic Medical Center received an unrestricted research grant from OrbusNeich Medical BV (Hoevelaken, the Netherlands). OrbusNeich Medical (Fort Lauderdale, Florida) is the sponsor of the MASCOT registry. Dr. de Winter has received institutional research grant support from OrbusNeich. Dr. Mehran has received institutional research grant support from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb/Sanofi, CSL Behring, Eli Lilly, Daiichi Sankyo, Medtronic, Novartis, and OrbusNeich; has received medical monitor funding from Claret Medical; has served as a consultant for Abbott Vascular, Boston Scientific, CardioKinetix, Cardiovascular Systems Inc., Medscape, Shanghai BraccoSine Pharmaceutical, Spectranetics; has received executive committee or advisory board funding from Janssen Pharmaceuticals, Osprey Medical, Bristol-Myers Squibb; has served on the Data Safety Monitoring Board for Watermark Research Partners; and has a spouse that has served as a consultant to The Medicines Company and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 26, 2018.
- Revision received March 21, 2018.
- Accepted April 21, 2018.
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