1-Year Results of the REMEDEE Registry: Clinical Outcomes After Deployment of the Abluminal Sirolimus-Coated Bioengineered (Combo) Stent in a Multicenter, Prospective All-Comers Registry
Pier Woudstra, Deborah N Kalkman, Peter den Heijer, Ian B A Menown, Andrejs Erglis, Harry Suryapranata, Karin E Arkenbout, Andrés Iñiguez, Arnoud W J van 't Hof, Philippe Muller, Jan G P Tijssen, Robbert J de Winter, Pier Woudstra, Deborah N Kalkman, Peter den Heijer, Ian B A Menown, Andrejs Erglis, Harry Suryapranata, Karin E Arkenbout, Andrés Iñiguez, Arnoud W J van 't Hof, Philippe Muller, Jan G P Tijssen, Robbert J de Winter
Abstract
Objectives: This registry evaluated the safety and clinical outcomes of the Combo stent in an all-comers population in routine clinical practice. We report 1-year results.
Background: Limitations of current generation drug-eluting stents (DES) are 3-fold: stent thrombosis, neoatherosclerosis related to impaired healing, and repeat revascularization due to (late-) in-stent restenosis. The Combo stent combines an abluminal biodegradable coating eluting sirolimus and a luminal anti-CD34(+) antibody layer to attract endothelial progenitor cells in order to promote vessel healing, thus preventing neointima formation and restenosis.
Methods: The REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) post-market registry was an international, multicenter, prospective trial that evaluated clinical outcomes after deployment of the Combo stent, in an all-comers population of patients treated with a Combo stent in the setting of routine clinical care. Clinical endpoints were target lesion failure (TLF), defined as a composite of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR).
Results: Between June 2013 and March 2014, a total of 1,000 patients were included in the registry, 49.9% of whom presented with acute coronary syndrome. Mean age was 65 ± 11 years old (range: 34 to 94 years of age), and 74% of patients were male; 58.9% of 1,255 lesions were American Heart Association type B2 or C lesions. The primary endpoints were 5.7% TLF, 1.7% cardiac death, 0.7% target vessel MI, and 4.4% TLR. Definite stent thrombosis occurred in 0.5% of subjects; no thrombosis occurred after 9 days post-stenting.
Conclusions: This registry showed excellent 1-year results of novel Combo bioengineered stent technology in an all-comers patient population. (Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE]; NCT01874002).
Keywords: Combo; PCI; clinical outcomes; endothelial progenitor cell; stent.
Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed