Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent

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.

One‐year clinical results of the NANO registry: A multicenter, prospective all‐comers registry study in patients receiving implantation of a polymer‐free sirolimus‐eluting stent

“…Compared to the RUDI‐FREE study and ASTUTE registry, the incidence of cardiac death was similar to the NANO registry (2.4 vs. 2.0 vs.1.8%, respectively). Of note, we reported 0.4% of MI, which was lower than that reported in most registries or randomized studies enrolling selected or unselected patients . This could be partly explained by the lack of routine cardiac enzyme testing and perioperative MI recordings.…”

“…Polymer‐free (PF)‐DESs are emerging technologies that offer controlled drug‐release with no polymer‐associated adverse effects . Previous studies have demonstrated that PF‐DESs are noninferior to durable polymer (DF)‐DESs in terms of their clinical outcome at 12 months in selected patient populations . However, there have been few studies evaluating the efficacy of PF‐DES in all‐comer patient populations undergoing percutaneous coronary intervention (PCI).…”

Polymer-free versus durable polymer drug-eluting stents in patients with coronary artery disease: A meta-analysis

“…After duplicate references were removed, we retrieved 1026 potentially relevant articles. In the present meta-analysis, we included 13 RCTs [ [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] ] consisting of 8021 patients with coronary artery disease who were randomized to receive PCI with either PF-DES (n = 4545) or DP-DES (n = 3476). Table 1 outlines the study characteristics of the included trials.…”

“…Thirteen trials [ [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] ] reported myocardial infarction (MI) in 8021 patients. There was no significant difference between patients receiving PF-DES and those receiving DP-DES for the risk of MI (4.0% vs 3.6%; RR, 1.06; 95% CI, 0.85–1.33; P = 0.61; I 2 = 0%; Fig.…”

One‐year clinical outcomes of patients treated with polymer‐free amphilimus‐eluting stents or zotarolimus‐eluting stents: A propensity‐score adjusted analysis

“…Sustained and homogeneous release of sirolimus (90 pg/cm 2 ) is facilitated according to Fick's law and completed over 90 days by laser‐dug wells on the stent surface (abluminal reservoirs) that are filled with a mixture of the drug and long‐chained fatty acids (amphilimus formulation). This distinct feature acts as an active drug‐carrier to enhance drug‐penetration and modulates bioavailability directly into the vessel wall [Color figure can be viewed at wileyonlinelibrary.com]…”