A novel polymer-free amphilimus-eluting stent was found to be safe and efficacious compared to the latest-generation permanent polymer drug-eluting stent, according to researchers for the ReCre8 trial presented at TCT 2018 in San Diego.
The study included 1,532 all-comer patients requiring percutaneous coronary intervention (PCI), who were then randomized in a 1:1 fashion to either the polymer-free amphilimus-eluting stent or the durable polymer zotarolimus-eluting stent. The device-oriented primary study endpoint of target lesion failure was defined as cardiac death, target-vessel MI, or target-lesion revascularization at 1 year.
According to the study results, target lesion failure occurred in 6.2% of patients in the amphilimus group compared to 5.6% in the zotarolimus group (risk difference: 0.5%; One-sided 95% CI, 2.6%; Pnoninferiority=0.0086). For the secondary study endpoint of net adverse clinical events at 1 year was 12.2% in the amphilimus group compared to 11.6% in the zotarolimus group.
“ReCre8 is the first randomized clinical trial of its kind and found that polymer-free amphilimus-eluting stents are shown to be clinically noninferior to latest-generation zotarolimus-eluting stents in terms of target-lesion failure at 12 months in an all comers PCI population,” said Pieter R. Stella, MD, PhD, head of Interventional Cardiology and manager of the Research Division Heart & Lungs at University Medical Center Utrecht in The Netherlands, in a press release “Although further study is warranted, one-month DAPT following these latest-generation drug-eluting stents in troponin-negative patients may be safe regarding stent thrombosis, especially in non-complex lesions.”
This study was simultaneously published in Circulation.