Clinical Evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries

Abstract

The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).

Two-year results after coronary stenting of small vessels in Japanese population using 2.25-mm diameter sirolimus-eluting stent with bioresorbable polymer: primary and long-term outcomes of CENTURY JSV study

“…Based on the outcomes reported in DES literature [9][10][11], assuming that the 9-month MACE-free rate of 2.25-mm diameter Ultimaster stent is 93% and the lower limit of the two-sided 95% CI to be at least 80%; to achieve 80% study power, 62 patients are required. Taking into account a dropout rate of 10%, we established 70 patients as the target sample size.…”

Resolute Integrity drug eluting stent safety and efficacy for the treatment of coronary artery disease

“…At this point, some of the studies in the global RESOLUTE clinical trial program are still active: RESOLUTE US, 8 RESOLUTE International, 20 and RESOLUTE All-Comers. 22 RESOLUTE Japan's preliminary results were shown at the Japanese Association of Cardiovascular Intervention's 2011 annual meeting, 24 but formal publication of results is still pending.…”

“…The RESOLUTE US trial is not only active but is still enrolling patients for a 38 mm stent-length substudy. 8 Other active studies, which will continue to accrue follow-up results in the next few years, are the TWENTE 25 trial and the LONG-DES IV trial. 27 Several other independent trials are summarized in In the following years we will see the R-ZES being tested against other DES, 31,32 such as the Taxus ® Liberté ® stent (Boston Scientific), 33 the Promus™ Element (Boston Scientif ic), 10 the Synergy™ (Boston Scientif ic), the Orsiro™ (Biotronik SE & Co, KG, Berlin, Germany), 34 the Taxus Element™ (Boston Scientific), and Xience Prime™ (Abbott Laboratories), 25 and against non-stent devices such as the IN.PACT Falcon drug-eluting balloon (Invatec Roncadelle, Italy).…”

“…The long-term safety of DES remains an important area of clinical investigation, particularly the avoidance of late stent thrombosis (ST). 8 Second-generation DES include the zotarolimus-eluting stent (ZES) (Endeavor ® A newer stent was recently released by Medtronic, with the name Resolute Integrity ® zotarolimus-eluting coronary stent system (R-ZES). The R-ZES is a device/drug combination product, comprised of the following device components: the Integrity coronary stent and MicroTrac delivery systems and a formulation of zotarolimus in a polymer coating.…”

DES Overview: A Historical and Current Review of Pivotal Clinical Trial Programs

“…Clinical trials evaluating the ENDEAVOR and RESOLUTE zotarolimus eluting stents A RESOLUTE U.S. trial is being conducted with 1402 patients in the RESOLUTE stent arm and is a single-arm, multicenter trial using Endeavor historical data as a comparator arm to evaluate the primary endpoint of target lesion failure (TLF; defined as cardiac death, target vessel MI, and target lesions revascularization) at 1 year. The RESOLUTE U.S. trial design allowed for 2.25 -4.2 mm vessel diameter and lesion length ≤ 27 mm (Yeung et al, 2011). The trial evaluated for non-inferiority and superiority using a performance goal from the Endeavor program and was able to demonstrate both non-inferiority and superiority at 1 year in terms of TLF.…”