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

• Published in: JACC. Cardiovascular interventions Vol. 9; no. 11; p. 1127
• Main Authors: Woudstra, Pier, Kalkman, Deborah N, den Heijer, Peter, Menown, Ian B A, Erglis, Andrejs, Suryapranata, Harry, Arkenbout, Karin E, Iñiguez, Andrés, van 't Hof, Arnoud W J, Muller, Philippe, Tijssen, Jan G P, de Winter, Robbert J
• Format: Journal Article
• Language: English
• Published: United States 13.06.2016
• Subjects: Acute Coronary Syndrome - diagnostic imaging; Acute Coronary Syndrome - therapy; Adult; Aged; Aged, 80 and over; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Coronary Thrombosis - etiology; Coronary Thrombosis - prevention & control; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction - etiology; Myocardial Infarction - prevention & control; Neointima; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus - administration & dosage; Sirolimus - adverse effects; Time Factors; Treatment Outcome; Wound Healing; stent; endothelial progenitor cell; clinical outcomes; Combo; PCI
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2016.02.052

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. 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. 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). 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. 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).