ReCre8 Trial Compares Polymer-Free Amphilimus-Eluting Stent to Durable Zotarolimus-Eluting Stent

September 22, 2018—The Cardiovascular Research Foundation (CRF) announced that findings from the ReCre8 trial were reported at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 21–25 in San Diego, California. The findings were simultaneously published online by Rik Rozemeijer, MD, et al in Circulation.

The large, randomized ReCre8 trial—which compares a novel polymer-free amphilimus-eluting stent to the latest-generation permanent polymer drug-eluting stent —found that the polymer-free stent was clinically safe and effective.

According to CRF, ReCre8 is a physician-initiated, prospective, multicenter, randomized, noninferiority trial of all-comer patients requiring percutaneous coronary intervention. Patients were randomized 1:1 to either polymer-free amphilimus-eluting stents (PF-AES; Cre8, Alvimedica Medical Technologies) or durable polymer zotarolimus-eluting stents (PP-ZES; Resolute Integrity, Medtronic).

Trial investigators enrolled 1,532 patients at three European sites between November 2014 and July 2017. Approximately 40% of randomized patients were troponin-positive and 60% were troponin-negative. In both treatment arms, patients with troponin-positive acute coronary syndromes were treated with 12 months of dual antiplatelet therapy (DAPT), whereas low-risk troponin-negative PF-AES patients were treated with an ultrashort (1 month) duration of DAPT. A total of 304 (20%) patients were diabetic.

The device-oriented primary endpoint of target lesion failure (TLF) was defined as cardiac death, target vessel myocardial infarction, or target lesion revascularization at 12 months.

TLF for the PF-AES group versust the PP-ZES group was 6.2% versus and 5.6%, respectively (risk difference, 0.5%; one-sided 95% confidence interval, 2.6%; P_{noninferiority} = .0086). The secondary endpoint of net adverse clinical events at 12 months was 12.2% for PF-AES and 11.6% for PP-ZES. Results were consistent across all subgroups, including DAPT duration.

In CRF's announcement, the trial's lead investigator Pieter R. Stella, MD, commented “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. Although further study is warranted, 1-month DAPT following these latest-generation drug-eluting stents in troponin-negative patients may be safe regarding stent thrombosis, especially in noncomplex lesions.” Dr. Stella is Head, Interventional Cardiology and Manager, Research Division Heart & Lungs at University Medical Center Utrecht in The Netherlands.