Author + information
- Received April 18, 2019
- Revision received July 26, 2019
- Accepted August 13, 2019
- Published online January 6, 2020.
- Maayan Konigstein, MDa,b,
- Pieter C. Smits, MDc,
- Michael P. Love, MBChB, MDd,
- Ori Ben-Yehuda, MDa,e,
- Melek Ozgu Ozan, MSa,
- Mengdan Liu, MSa,
- Gidon Y. Perlman, MDf,g,
- Martin B. Leon, MDa,e,
- Gregg W. Stone, MDa and
- David E. Kandzari, MDh,∗ (, )@Kandzari
- aClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- bTel Aviv-Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
- cMaasstad Ziekenhuis, Rotterdam, the Netherlands
- dSt. Boniface General Hospital, University of Manitoba, Winnipeg, Manitoba, Canada
- eDivision of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- fHadassah Hebrew University Medical Center, Jerusalem, Israel
- gMedinol Ltd., Tel Aviv, Israel
- hPiedmont Heart Institute, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. David E. Kandzari, Piedmont Heart Institute, 95 Collier Road, Suite 2065, Atlanta, Georgia 30309.
Objectives This study sought to determine clinical outcomes between treatment groups over long-term follow-up.
Background The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.
Methods Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization.
Results A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel–related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39).
Conclusions In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.
Dr. Smits has received institutional research grant support from Abbott and St. Jude Medical; has received consulting fees from Abbott, St. Jude Medical, and AstraZeneca; and has received speaker fees from Terumo. Dr. Perlman is an employee of Medinol Ltd. Dr. Leon has served on the medical advisory board for and owns equity in Medinol. Dr. Kandzari has received institutional research grant support from Biotronik AG, Boston Scientific, Orbus Neich, and Medtronic; and has received consulting honoraria and research grant support from Biotronik AG, Medtronic, and Cardinal Health. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 18, 2019.
- Revision received July 26, 2019.
- Accepted August 13, 2019.
- 2020 American College of Cardiology Foundation
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