Journal Article

Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial

Van Leeuwen, Frank, Mauri, Laura, Jorissen, Brenda, Kurowski, Volkhard, Parikh, Keyur, McFadden, Eugene, Greenwood, John P, Vranckx, Pascal, Wijns, William, Gao, Runlin, Bode, Christoph, Camenzind, Edoardo, Boersma, Eric, Steg, Ph Gabriel, Serruys, Patrick W, O'Neil, William W

2012

Overview

We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58–1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. Medtronic, Inc.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Acute coronary syndromes / Aged / Antibacterial agents / Antibiotics. Antiinfectious agents. Antiparasitic agents / Biological and medical sciences / Coronary Artery Disease - pathology / Coronary Artery Disease - therapy / Coronary Restenosis - etiology / coronary vessels / Drug-Eluting Stents - adverse effects / Emergency procedures / Female / General aspects / Heart attacks / Humans / Internal Medicine / Internet / Male / Medical sciences / Middle Aged / patients / Pharmacology. Drug treatments / Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) / Sirolimus - administration & dosage / Sirolimus - analogs & derivatives / Stents / Studies / therapeutics / Thromboembolism / thrombosis / Thrombosis - etiology