Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial

Background: Large scale randomized comparison of drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study sought to prove the non-inferiority of the DP-DES compared with the BP-DES in such patients. Methods: The HOST-REDUCE-POLYTECH-ACS trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, non-inferiority trial which compared the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary endpoint was patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization) at 12 months. The key secondary endpoint was device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months. Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, POCO occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (Absolute risk difference: -1.2%, P non-inferiority <0.001). The key secondary endpoint, DOCO, occurred less frequently in the DP-DES group (DP-DES vs. BP-DES: 2.6% vs. 3.9%, HR 0.67, 95% CI 0.46-0.98, p=0.038), mostly due to a reduction in target lesion revascularization. The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively). Conclusions: In ACS patients receiving percutaneous coronary intervention (PCI), DP-DES was non-inferior to BP-DES with regard to POCO at 12 months after index PCI. Clinical Trial Registration: URL: clinicaltrials.gov Unique identifier: NCT02193971