Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Reduction of Late Lumen Loss

Abstract

MD; for the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial InvestigatorsBackground-Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis. Methods and Results-To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (Pϭ0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups). Conclusions-The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent.

Polymer-Free Sirolimus- and Probucol-Eluting Versus New Generation Zotarolimus-Eluting Stents in Coronary Artery Disease

“…24 The availability of on-site coating technology has enabled the investigation of a variety of drug and polymer coatings in preclinical studies 11,12,25 and clinical trials. 9,10,13,26,27 The current device iteration is coated with a mixture of sirolimus and probucol. Probucol is a potent antioxidant, which has proven effects in reducing restenosis and promoting endothelialization.…”

Short- and Long-Term Outcomes With Drug-Eluting and Bare-Metal Coronary Stents

“…We excluded the ZoMaxx I 24 and II 25 trials because the ZoMaxx stent is a different ZES stent platform (TriMaxx; Abbott Laboratories; stainless steeltantalum stent platform to deliver zotarolimus 10 g/mm via phosphorylcholine polymer system). Similarly, we excluded the ISAR (Intracoronary Stenting and Antithrombotic Regimen) Test 1 26 trial because it tested a non-polymer-based rapamycineluting stent. The ISAR Test 2 27 data included were the SES and ZES arms only, with the polymer-free dual-DES arm of the trial excluded.…”

Coronary Arterial Drug-Eluting Stent: From Structure to Clinical

“…A microporous stainless steel stent (Yukon, Translumina, Germany) allows for dose-adjustable, multiple drugs, and on-site coating 105 [63]. The system is therapeutically effective with rapamycin 106 . A nanoporous hydroxyapetite (a biocompatible crystalline derivative of calcium phosphate) coating, which can be impregnated with anti-restenotic drugs, is currently under development 107 .…”