ArticleCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2021
Final five-year results of the REMEDEE Registry: Real-world experience with the dual-therapy COMBO stent.
Article in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed.
- Challenges and Advances in Interventional Cardiology for Coronary Artery Disease Management.Medicina (Kaunas, Lithuania) · 2024Review
- The path to a hemocompatible cardiovascular implant: Advances and challenges of current endothelialization strategies.Frontiers in cardiovascular medicine · 2022Review
- Final five-year results of the REMEDEE Registry: Real-world experience with the dual-therapy COMBO stent.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2021Article
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16 authors.
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Abstract
objectivesThis final report from the REMEDEE Registry assessed the long-term safety and efficacy of the dual-therapy COMBO stent in a large unselected patient population.
backgroundThe bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. Data of long-term safety and efficacy of the this stent is lacking.
methodsThe prospective, multicenter, investigator-initiated REMEDEE Registry evaluated clinical outcomes after COMBO stent implantation in daily clinical practice. One thousand patients were enrolled between June 2013 and March 2014.
resultsFive-year follow-up data were obtained in 97.2% of patients. At 5-years, target lesion failure (TLF) (composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) was present in 145 patients (14.8%). Definite or probable stent thrombosis (ST) occurred in 0.9%, with no additional case beyond 3-years of follow-up. In males, 5-year TLF-rate was 15.6 versus 12.6% in females (p = .22). Patients without diabetes mellitus (DM) had TLF-rate of 11.4%, noninsulin-treated DM 22.7% (p = .001) and insulin-treated DM 41.2% (p < .001). Patients presenting with non-ST segment elevation acute coronary syndrome (NSTE-ACS) had higher incidence of TLF compared to non-ACS (20.4 vs. 13.3%; p = .008), while incidence with STE-ACS was comparable to non-ACS (10.7 vs. 13.3%; p = .43).
conclusionPercutaneous coronary intervention with the dual-therapy COMBO stent in unselected patient population shows low rates of TLF and ST to 5 years. Remarkably, no case of ST was noted beyond 3 years.
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