The 3-year landmark analysis from the ReCre8 multi-center, randomized, all-comer trial assessing noninferiority of polymer-free amphilimus-eluting stents (PF-AES) compared to permanent polymer zotarolimus-eluting stents (PP-ZES) were presented at CRT 2021. The PF-AES has a novel design with thin-strut (80 um) cobalt-chromium alloy coated with a bio-inducer surface to promote endothelialization and abluminal reservoirs containing sirolimus and fatty acids (amphilimus formulation) that is released over a 90 day period. The study randomized (1:1) 1,491 patients (ACS and non-ACS) at 3 centers in Northern Europe to PF-AES vs. PP-ZES. 47% of the patients were diagnosed with ACS pre-randomization and patients were stratified according to whether they had diabetes and/or troponin elevation. Patients without troponin elevation received one month of DAPT whereas those with troponin elevation received 12 months of DAPT.
The primary endpoint was target-lesion failure (TLF) which included cardiac death, target-vessel MI (TVMI) and target-lesion revascularization (TLR). The previously published 1-year landmark date showed no significant difference in primary outcomes between the two groups. The 3-year landmark analysis revealed that there remained no significant difference in the primary outcome at 3 years. Target lesion failure (TLF) occurred in 5.2% of patients in the PF-AES arm compared to 4.8% of patients in the PP-ZES arm. Noninferiority held true regardless of whether the index procedure was done in the setting of ACS. Subgroup analyses also showed no difference in the primary outcomes based on lesion complexity, diabetes, age or gender.
The ReCre8 study demonstrated noninferiority of the novel PF-AES compared with PP-ZES in all-comer patients at 3 years regarding target lesion failure in ACS and non-ACS patients with no late catch-up phenomenon occurring beyond one year. The length of DAPT dosing was not randomized in this trial, thus, no conclusions can be drawn regarding the ideal length of DAPT dosing in patients undergoing PF-AES implantation.