Comparison of ridaforolimus-eluting and zotarolimus-eluting coronary stents: 5-Year outcomes from the BIONICS and NIREUS trials

Abstract Introduction Despite similarities between different modern drug eluting stents (DES), their comparative short and long-term safety and efficacy has generated much interest and yielded conflicting results. The BIONICS and the NIREUS randomized clinical trials showed non-inferiority of the Ridaforolimus eluting stent (RES) compared to the Zotarolimus-eluting stent (ZES) with respect to 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss. Aim To evaluate clinical outcomes between treatment groups over 5 years follow-up Methods BIONICS and NIREUS were prospective, randomized, single-blind multicenter trials comparing RES and ZES in patients undergoing PCI. Patients were blinded to treatment assignment and randomized to RES or ZES in a 1:1 fashion in BIONICS, and in 2:1 fashion in NIREUS. Clinical events were assessed during hospital stay, at 30 days, 1 year, and yearly thereafter, up to 5 years. The The primary endpoint in the current study was the 5-year rate of target lesion failure (TLF). Results The study population included 2221 patients enrolled in the BIONICS (n=1919) and NIREUS (n=302) studies. Median follow-up was 1822 days (interquartile range 1783 to 1847 days). Mean age was 63.2±10.3 years, and most patients were men (79.7%). Clinical presentation with ACS was similar between groups (38.9% versus 37.9%, RES versus ZES, respectively, p=0.38). Procedural characteristics were similar for patients treated with RES and ZES. A mean of 1.6±0.9 and 1.5±0.8 stents were implanted in RES and ZES patients, respectively, p=0.08. Post dilatation was performed more frequently in the RES group (63.3% versus 60.1%, p=0.02) and procedure duration was longer in RES versus ZES patients (47.0±31.8 minutes versus 44.6±29.2 minutes, p=0.01). Device success was high in both groups but slightly higher in the ZES group (98.2% versus 99.5% for RES and ZES, respectively, p=0.002) yet with similar procedural success (97.9% versus 97.3%, p=0.49). At 5 years, the primary endpoint of TLF 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 MI (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 (TVR) 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 two randomized trials, 5-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 patients with coronary artery disease.Central illustrationZES vs. RES