TY - JOUR
T1 - 1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent
T2 - Primary Results of the COMBO Collaboration
AU - MASCOT
AU - REMEDEE Registry Investigators
AU - de Winter, Robbert J.
AU - Chandrasekhar, Jaya
AU - Kalkman, Deborah N.
AU - Aquino, Melissa B.
AU - Woudstra, Pier
AU - Beijk, Marcel A.
AU - Sartori, Samantha
AU - Baber, Usman
AU - Tijssen, Jan G.
AU - Koch, Karel T.
AU - Dangas, George D.
AU - Colombo, Antonio
AU - Mehran, Roxana
AU - Ong, Tiong Kiam
AU - Lee, Michael
AU - Iniguez, Andres
AU - Rowland, Stephen
AU - Ghodsi, Newsha
AU - Marx, Steven
AU - DiStefano, Douglas
AU - Weinberger, Jesse
AU - Wong, Shing Chiu
AU - Darrow, Bruce
AU - Kaufman, David
AU - Milstein, Mark
AU - Chandrasekhar, Jaya
AU - Sartori, Samantha
AU - Snyder, Clayton
AU - Franklin-Bond, Theresa
AU - Cha, Jin Young
AU - Vandertie, Lynn
AU - Whittaker, Emma
AU - Allen, Kate
AU - Vogel, Birgit
AU - Farhan, Serdar
AU - Sorrentino, Sabato
AU - Ge, Zhen
AU - Carlier, Marc
AU - Pourbaix, Suzanne
AU - Borisov, Borislav
AU - Atzev, Borislav
AU - Vasilev, Dobrin
AU - Christou, Christos
AU - Pešl, Ladislav
AU - Coufal, Zdeněk
AU - Kala, Petr
AU - Jeřábek, Petr
AU - Hájek, Petr
AU - Santoso, Teguh
AU - Munawar, Muhammad
N1 - Funding Information:
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.
Publisher Copyright:
© 2018
PY - 2018/10/8
Y1 - 2018/10/8
N2 - 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.
AB - 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.
KW - drug-eluting stent(s)
KW - endothelial progenitor cell anti-CD34+ antibody
KW - percutaneous coronary intervention
KW - stent healing
UR - http://www.scopus.com/inward/record.url?scp=85053759376&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2018.04.038
DO - 10.1016/j.jcin.2018.04.038
M3 - Article
C2 - 30286855
AN - SCOPUS:85053759376
VL - 11
SP - 1969
EP - 1978
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 19
ER -