Pier Woudstra1, Deborah N Kalkman1, Peter den Heijer2, Ian B A Menown3, Andrejs Erglis4, Harry Suryapranata5, Karin E Arkenbout6, Andrés Iñiguez7, Arnoud W J van 't Hof8, Philippe Muller9, Jan G P Tijssen1, Robbert J de Winter10. 1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 2. Department of Cardiology, Amphia Hospital Breda, Breda, the Netherlands. 3. Department of Cardiology, Craigavon Cardiac Centre, Craigavon, United Kingdom. 4. Department of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia. 5. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. 6. Department of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands. 7. Department of Cardiology, Hospital Álvaro Cunqueiro-Complejo Hospitalario Universitario, Vigo, Spain. 8. Department of Cardiology, Isala Klinieken, Zwolle, the Netherlands. 9. Department of Cardiology, Institut National de Cardiochirurgie et de Cardiologie Interventionnelle, Luxembourg, Luxembourg. 10. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: r.j.dewinter@amc.uva.nl.
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).
RCT Entities:
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).
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