1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent: Primary Results of the COMBO Collaboration

MASCOT, REMEDEE Registry Investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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)

Original languageEnglish
Pages (from-to)1969-1978
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume11
Issue number19
DOIs
Publication statusPublished - 8 Oct 2018

Fingerprint

Stents
Sirolimus
Registries
Therapeutics
Safety
Diabetes Mellitus
Myocardial Infarction
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Marketing
Multicenter Studies
Chronic Kidney Failure
Endothelium
Anti-Idiotypic Antibodies
Polymers
Thrombosis
Prospective Studies
Insulin
Incidence

Keywords

  • drug-eluting stent(s)
  • endothelial progenitor cell anti-CD34+ antibody
  • percutaneous coronary intervention
  • stent healing

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent : Primary Results of the COMBO Collaboration. / MASCOT; REMEDEE Registry Investigators.

In: JACC: Cardiovascular Interventions, Vol. 11, No. 19, 08.10.2018, p. 1969-1978.

Research output: Contribution to journalArticle

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abstract = "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)",
keywords = "drug-eluting stent(s), endothelial progenitor cell anti-CD34+ antibody, percutaneous coronary intervention, stent healing",
author = "MASCOT and {REMEDEE Registry Investigators} and {de Winter}, {Robbert J.} and Jaya Chandrasekhar and Kalkman, {Deborah N.} and Aquino, {Melissa B.} and Pier Woudstra and Beijk, {Marcel A.} and Samantha Sartori and Usman Baber and Tijssen, {Jan G.} and Koch, {Karel T.} and Dangas, {George D.} and Antonio Colombo and Roxana Mehran and Antonio Colombo and Roxana Mehran and Ong, {Tiong Kiam} and Michael Lee and Andres Iniguez and Stephen Rowland and Newsha Ghodsi and Steven Marx and Douglas DiStefano and Jesse Weinberger and Wong, {Shing Chiu} and Bruce Darrow and David Kaufman and Mark Milstein and Roxana Mehran and Jaya Chandrasekhar and Usman Baber and Melissa Aquino and Samantha Sartori and Clayton Snyder and Theresa Franklin-Bond and Cha, {Jin Young} and Lynn Vandertie and Emma Whittaker and Kate Allen and Birgit Vogel and Serdar Farhan and Sabato Sorrentino and Zhen Ge and Marc Carlier and Suzanne Pourbaix and Borislav Borisov and Borislav Atzev and Dobrin Vasilev and Christos Christou and Ladislav Pešl and Oteh Maskon",
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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 - 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 - Mehran, Roxana

AU - Chandrasekhar, Jaya

AU - Baber, Usman

AU - Aquino, Melissa

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 - Maskon, Oteh

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

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