1. Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 5-Year Outcomes From the BIONICS and NIREUS Trials.
- Author
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Zornitzki L, Smits PC, Love MP, Stone GW, Kandzari DE, Redfors B, Ozan MO, and Konigstein M
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Time Factors, Cardiovascular Agents administration & dosage, Cardiovascular Agents adverse effects, Coronary Artery Disease therapy, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Artery Disease surgery, Coronary Stenosis therapy, Coronary Stenosis diagnostic imaging, Coronary Stenosis mortality, Prosthesis Design, Drug-Eluting Stents, Sirolimus analogs & derivatives, Sirolimus pharmacology, Sirolimus administration & dosage, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods, Coronary Angiography
- Abstract
Background: The BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and the NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) randomized clinical trials showed noninferiority of the ridaforolimus-eluting stent (RES) compared with the zotarolimus-eluting stent (ZES) with respect to 1-year target-lesion failure and 6-month angiographic late lumen loss. We aimed to evaluate clinical outcomes between treatment groups over a 5-year follow-up., Methods and Results: Patient-level data from the BIONICS (n=1919) and NIREUS (n=302) were pooled, comparing the outcomes of patients implanted with RES and ZES. The primary end point was the 5-year rate of target-lesion failure. A total of 2221 patients (63.2±10.3 years, 79.7% men) undergoing percutaneous coronary intervention with RES (n=1159) or ZES (n=1062) were included. Most clinical and angiographic characteristics were similar between groups. At 5 years, the primary end point of target-lesion failure was similar between treatment groups (12.2% RES versus 11.3% ZES, P =0.52). Rates of TLR (7.6% RES versus 6.8% ZES, P =0.42) target-vessel-related myocardial infarction (4.8% RES versus 4.9% ZES, P =0.95) and stent thrombosis (0.9% RES versus 0.9% ZES, P =0.87) also did not differ between groups. Target-vessel revascularization and cardiac death were higher among the RES group (12.3% versus 9.5% P =0.037, and 3.6% versus 2.2% P =0.042, respectively). However, after correction for baseline characteristics, there was no significant difference in cardiac death between groups., Conclusions: In a pooled analysis of 2 randomized trials, 5-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 patients with coronary artery disease.
- Published
- 2024
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