Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial.

Autor:	von Birgelen C; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands; Department of Health Technology and Services Research, University of Twente, Enschede, Netherlands. Electronic address: c.vonbirgelen@mst.nl., Sen H; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Lam MK; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Danse PW; Department of Cardiology, Rijnstate Hospital, Arnhem, Netherlands., Jessurun GA; Department of Cardiology, Scheper Hospital, Emmen, Netherlands., Hautvast RW; Department of Cardiology, Medical Center Alkmaar, Alkmaar, Netherlands., van Houwelingen GK; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Schramm AR; Department of Cardiology, Scheper Hospital, Emmen, Netherlands., Gin RM; Department of Cardiology, Rijnstate Hospital, Arnhem, Netherlands., Louwerenburg JW; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., de Man FH; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Stoel MG; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Löwik MM; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Linssen GC; Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, Netherlands., Saïd SA; Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, Netherlands., Nienhuis MB; Department of Cardiology, Queen Beatrix Hospital, Winterswijk, Netherlands., Verhorst PM; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Basalus MW; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands., Doggen CJ; Department of Health Technology and Services Research, University of Twente, Enschede, Netherlands., Tandjung K; Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2014 Feb 01; Vol. 383 (9915), pp. 413-23. Date of Electronic Publication: 2013 Oct 31.
DOI:	10.1016/S0140-6736(13)62037-1
Abstrakt:	Background: Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial. Methods: In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707. Findings: Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned study treatment (six [1%] in the zotarolimus-eluting stent group vs five [1%] in the everolimus-eluting stent group; p=0·22). 12-month follow-up results were available for 1810 patients (one patient in the zotarolimus-eluting stent group withdrew consent). The primary endpoint was met by 55 (6%) of 905 patients in the zotarolimus-eluting stent group and 47 (5%) of 905 in the everolimus-eluting stent group. The zotarolimus-eluting stent was non-inferior to the everolimus-eluting stent (absolute risk difference 0·88%, 95% CI -1·24% to 3·01%; upper limit of one-sided 95% CI 2·69%; non-inferiority p=0·006). We noted no significant between-group differences in individual components of the primary endpoint. Definite stent thrombosis occurred in three (0·3%) patients in the zotarolimus-eluting stent group and six (0·7%) patients in the everolimus-eluting stent group (p=0·34). Longitudinal stent deformation was seen only in the everolimus-eluting stent group (nine [1·0%] of 905 vs 0 of 906, p=0·002; nine of 1591 [0·6%] everolimus-eluting stents implanted became deformed), but was not associated with any adverse events. Interpretation: Both stents were similarly efficacious and safe, and provided excellent clinical outcomes, especially in view of the large number of patients who presented with acute myocardial infarctions. Funding: Boston Scientific, Medtronic. (Copyright © 2014 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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