1. Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent.
- Author
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Rozemeijer R, Stein M, Voskuil M, van den Bor R, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, and Stella PR
- Subjects
- Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome mortality, Aged, Angina, Stable diagnosis, Angina, Stable mortality, Angina, Unstable diagnosis, Angina, Unstable mortality, Cardiovascular Agents adverse effects, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Coronary Thrombosis etiology, Europe, Female, Humans, Male, Middle Aged, Myocardial Infarction diagnosis, Myocardial Infarction mortality, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention mortality, Prospective Studies, Prosthesis Design, Risk Factors, Sirolimus administration & dosage, Sirolimus adverse effects, Time Factors, Treatment Outcome, Acute Coronary Syndrome therapy, Angina, Stable therapy, Angina, Unstable therapy, Cardiovascular Agents administration & dosage, Coronary Artery Disease therapy, Drug-Eluting Stents, Myocardial Infarction therapy, Percutaneous Coronary Intervention instrumentation, Polymers chemistry, Sirolimus analogs & derivatives
- Abstract
Background: Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution technology in the current era of drug-eluting stents. The clinical safety and efficacy of PF-AES as compared with latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES) have not yet been investigated in a large randomized trial., Methods: In this physician-initiated, prospective, multicenter, randomized, noninferiority trial, an all-comers population requiring percutaneous coronary intervention was enrolled across 3 European sites. Randomization (1:1 ratio) to PP-ZES or PF-AES was performed after stratification for troponin status and diabetes mellitus. In both treatment arms, troponin-positive patients were planned for 12-month dual antiplatelet therapy, whereas troponin-negative patients were planned for 1-month dual antiplatelet therapy. Outcome assessors were blinded to the allocated treatment. The device-oriented primary end point of target-lesion failure was defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3.5% noninferiority margin)., Results: In total, 1502 patients were randomized and 1491 treated with the assigned stent and available for follow-up. The primary end point occurred in 42 (5.6%) of the 744 patients receiving PP-ZES versus 46 (6.2%) of the 747 patients receiving PF-AES. PF-AES were clinically noninferior to PP-ZES (risk difference, 0.5%; upper limit 1-sided 95% confidence interval, 2.6%; P
noninferiority =0.0086). Cardiac death occurred in 10 (1.3%) versus 10 patients (1.3%; P value for difference, 1.00), target-vessel myocardial infarction occurred in 18 (2.4%) versus 17 patients (2.3%; P value for difference, 0.87), and target-lesion revascularization occurred in 22 (2.9%) versus 20 patients (2.6%; P value for difference, 0.75) for PF-AES as compared with PP-ZES. Overall, definite or probable stent thrombosis occurred in 1.0%., Conclusions: PF-AES were noninferior to PP-ZES regarding target-lesion failure at 12 months. Findings regarding the secondary end point and prespecified subgroups were generally consistent with that of the primary end point., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02328898.- Published
- 2019
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