Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 2-Year Clinical Outcomes From the BIONICS and NIREUS Trials - The 66th Annual Conference of the Israel Heart Society & The Israel Society of Cardiothoracic Surgery

Maayan Konigstein ^1,2 Pieter C. Smits ³ Michael P. Love ⁴ Ori Ben-Yehuda ¹ Melek Ozgu Ozan ¹ Mengdan Liu ¹ Gidon Y. Perlman ⁵ Martin B. Leon ¹ Gregg W. Stone ¹ David E. Kandzari ⁶

¹Clinical Trials Center, Cardiovascular Research Foundation
²Cardiology, Cardiovascular Research Foundation
³Cardiology, Maasstad Ziekenhuis
⁴Cardiology, St. Boniface General Hospital
⁵Cardiology, Hadassah Hebrew University Medical Center
⁶Cardiology, Piedmont Heart Institute

Background: The safety and efficacy of ridaforolimus-eluting stents (RES) was evaluated in the BIONICS and the NIREUS trials demonstrating noninferiority of RES in comparison with zotarolimus-eluting stents (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.

Objectives: To determine whether clinical outcomes are similar between treatment groups over long-term follow-up.

Methods: Patient-level data from the BIONICS (n=1919) and NIREUS (n=302) randomized controlled trials were pooled, and clinical outcomes in patients implanted with RES and ZES were compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes (ACS) and complex lesions. The primary endpoint was the 2-year rate of TLF (composite of cardiac death, target vessel myocardial infarction [MI], or clinically driven target lesion revascularization [TLR]).

Results: A total of 2221 patients (63.2±10.3 years, 79.7% men) undergoing percutaneous coronary intervention (PCI) with RES (n=1159) or ZES (n=1062) were included in the pooled analysis. Clinical and angiographic characteristics were similar between RES and ZES groups. Overall, the prevalence of diabetes and ACS was 31.8% and 38.4%, respectively. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% versus 7.2%, p=0.81). Rates of TLR (4.8% RES versus 4.1% ZES, p=0.46) and target vessel-related MI (3.1% RES versus 3.8% ZES, p=0.39) did not statistically differ between treatment groups. The overall rate of stent thrombosis (ST) was also similar (0.5% RES versus 0.9% ZES, p=0.35), with a trend toward lower late/very late ST among the RES group (0.09% versus 0.48%, p=0.09).

Conclusions: In a pooled analysis of randomized trials, 2-year clinical outcomes were similar between patients undergoing PCI with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients representative of clinical practice.