Polymer-free amphilimus-eluting stents (PF-AES) are clinically non-inferior to permanent polymer zotarolimus-eluting stents (PP ZES) in terms of target lesion failure at 12 months, said researchers from the ReCre8 trial presented Sept. 22 at TCT 2018 and published in Circulation.

The trial, conducted by Pieter Stella, MD, PhD, et al., randomized 1,532 patients at three European sites to either PF-AES or PP ZES. The primary endpoint was target lesion failure at 12 months, with the secondary endpoint of net adverse clinical events also at 12 months.

Overall results showed clinical non-inferiority was met for the primary endpoint (6.2 PF-AES vs. 5.6 for PP ZES; p=0.0086). Researchers noted findings "generally consistent with the primary endpoint" in terms of the secondary endpoint. No significant interactions were observed across all subgroups.

Looking ahead, Stella and colleagues said that future trials need to investigate efficacy of PF-AES in patients with diabetes. Additionally, the safety of short dual antiplatelet therapy duration (one month) with these devices in troponin-negative patients' needs to be evaluated further. This was not powered in the ReCre8 trial.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Percutaneous Coronary Intervention, Drug-Eluting Stents, Polymers

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