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 - 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 - van 't Hof, Arnoud
AU - MASCOT
N1 - Copyright © 2018. Published by Elsevier Inc.
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. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002).
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. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002).
KW - drug-eluting stent(s)
KW - endothelial progenitor cell anti-CD34+antibody
KW - percutaneous coronary intervention
KW - stent healing
KW - PERCUTANEOUS CORONARY INTERVENTION
KW - SIROLIMUS-ELUTING STENTS
KW - CHRONIC KIDNEY-DISEASE
KW - POLYMER-COATED STENT
KW - ARTERY-DISEASE
KW - ANTIPLATELET THERAPY
KW - NON-INFERIORITY
KW - FOCUSED UPDATE
KW - EVEROLIMUS
KW - MULTICENTER
U2 - 10.1016/j.jcin.2018.04.038
DO - 10.1016/j.jcin.2018.04.038
M3 - Article
C2 - 30286855
SN - 1936-8798
VL - 11
SP - 1969
EP - 1978
JO - Jacc-Cardiovascular Interventions
JF - Jacc-Cardiovascular Interventions
IS - 19
ER -