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

Robbert J de Winter, Jaya Chandrasekhar, Deborah N Kalkman, Melissa B Aquino, Pier Woudstra, Marcel A Beijk, Samantha Sartori, Usman Baber, Jan G Tijssen, Karel T Koch, George D Dangas, Antonio Colombo, Roxana Mehran, Arnoud van 't Hof, MASCOT

Research output: Contribution to journalArticleAcademicpeer-review

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

Keywords

  • drug-eluting stent(s)
  • endothelial progenitor cell anti-CD34+antibody
  • percutaneous coronary intervention
  • stent healing
  • PERCUTANEOUS CORONARY INTERVENTION
  • SIROLIMUS-ELUTING STENTS
  • CHRONIC KIDNEY-DISEASE
  • POLYMER-COATED STENT
  • ARTERY-DISEASE
  • ANTIPLATELET THERAPY
  • NON-INFERIORITY
  • FOCUSED UPDATE
  • EVEROLIMUS
  • MULTICENTER

Cite this

de Winter, R. J., Chandrasekhar, J., Kalkman, D. N., Aquino, M. B., Woudstra, P., Beijk, M. A., Sartori, S., Baber, U., Tijssen, J. G., Koch, K. T., Dangas, G. D., Colombo, A., Mehran, R., van 't Hof, A., & MASCOT (2018). 1-Year Clinical Outcomes of All-Comer Patients Treated With the Dual-Therapy COMBO Stent: Primary Results of the COMBO Collaboration. Jacc-Cardiovascular Interventions, 11(19), 1969-1978. https://doi.org/10.1016/j.jcin.2018.04.038