@article{993a6f5cc4f4446b90ff1675eb3d92b0,
title = "Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease: Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis)",
abstract = "BACKGROUND: The safety and efficacy of a novel cobalt alloybased coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice.",
keywords = "Coronary intervention, Drug-eluting stent, Percutaneous, Ridaforolimus, Stent thrombosis",
author = "Kandzari, {David E.} and Smits, {Pieter C.} and Love, {Michael P.} and Ori Ben-Yehuda and Shmuel Banai and Robinson, {Simon D.} and Michael Jonas and Ran Kornowski and Rodrigo Bagur and Andres Iniguez and Haim Danenberg and Robert Feldman and Rajiv Jauhar and Harish Chandna and Manish Parikh and Perlman, {Gidon Y.} and Mercedes Balcells and Peter Markham and Ozan, {Melek Ozgu} and Philippe Genereux and Edelman, {Elazer R.} and Leon, {Martin B.} and Stone, {Gregg W.}",
note = "Funding Information: This trial was funded by Medinol Ltd, Tel Aviv, Israel. Funding Information: From Piedmont Heart Institute, Atlanta, GA (D.E.K.); Maas-stad Hospital, Rotterdam, The Netherlands (P.C.S.); Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia (M.P.L.); Columbia University Medical Center and the Cardiovascular Research Foundation, New York (O.B.-Y., M.P., M.O.O., P.G., M.B.L., G.W.S.); Tel Aviv Medical Center, Israel (S.B.); Victoria Heart Institute Foundation, British Columbia, Canada (S.D.R.); Kaplan Medical Center, Rehovot, Israel (M.J.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Centre Hospitalier Universitaire de Quebec, Canada (R.B.); Hospital Meixoeiro, Vigo, Spain (A.I.); Hadassah Hebrew University Medical Center, Jerusalem, Israel (H.D., G.Y.P.); MediQuest Research Group, Ocala, FL (R.F.); North Shore University Hospital, New York (R.J.); Victoria Heart and Vascular Center, TX (H.C.); Medinol Ltd, Tel Aviv, Israel (G.Y.P.); Massachusetts Institute of Technology, Cambridge (M.B., E.R.E.); and CBSET Inc, Lexington, MA (P.M.). Funding Information: and receiving research support from Medtronic, Abbott Vascular, Boston Scientific, Biotronik, St Jude Medical, and Medinol. Dr Smits reports receiving consulting fees from Medinol, Abbott Vascular, and St Jude Medical and receiving research support from Abbott Vascular, St Jude Medical, and Terumo. Dr Feldman reports receiving consulting fees from Boston Scientific. Dr Jonas reports receiving consulting fees from Medinol. Dr Chandna reports owning stock options of Gilead Pharma and being on speaker boards for Pfizer, Jennsen, and Novartis Pharma. Dr Leon reports having an equity relationship with Medinol and serving on the medical advisory board of Medtronic. Dr Edelman reports being the founder of and holding equity in BioRest. Dr Ben-Yehuda and Ms Ozan are employees of the Cardiovascular Research Foundation, which received funding from Medi-nol Ltd for the conduct of the trial. Dr Perlman reports being an employee of Medinol. The other authors report no conflicts. Publisher Copyright: {\textcopyright} 2017 American Heart Association, Inc.",
year = "2017",
month = oct,
day = "1",
doi = "10.1161/CIRCULATIONAHA.117.028885",
language = "English",
volume = "136",
pages = "1304--1314",
journal = "Circulation",
issn = "0009-7322",
publisher = "Lippincott Williams and Wilkins",
number = "14",
}