Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial)

Lisette Okkels Jensen, Per Thayssen, Henrik Steen Hansen, Evald Høj Christiansen, Hans-Henrik Tilsted, Lars Romer Krusell, Anton Boel Villadsen, Anders Junker, Knud Nørregaard Hansen, Anne Kaltoft, Michael Maeng, Knud Erik Pedersen, Steen Dalby Kristensen, Hans Erik Bøtker, Jan Ravkilde, Richardo Sanchez, Jens Aarøe, Morten Madsen, Henrik Toft Sørensen, Leif ThuesenJens Flensted Lassen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

138 Citationer (Scopus)

Abstract

BACKGROUND: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. METHODS AND RESULTS: The Scandinavian Organization for Randomized Trials with Clinical Outcome IV trial was a randomized multicenter, single-blind, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The non-inferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9-month and 18-month follow-up. 1,390 patients were assigned to receive the everolimus-eluting stent, and 1,384 patients were assigned to receive the sirolimus-eluting stent. At 9-month follow-up, 68 [4.9%] patients treated with the everolimus-eluting stent versus 72 [5.2%] patients treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio (HR) =0.94; 95% confidence interval (CI): 0.67-1.31) (p for non-inferiority=0.01). At 18-month follow-up, this differential remained: 99 [7.2%] patients treated with the everolimus-eluting stent versus 105 [7.6%] (HR=0.94, 95% CI: 0.71-1.23). At 9-month follow-up, rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 [0.1%] patients versus 9 [0.7%] patients, (HR=0.22, 95% CI:0.05-1.02)).At 18-monthfollow-up, this difference was sustained (3 [0.2%] patients versus 12 [0.9%] patients; (HR=0.25, 95% CI:0.07-0.88). CONCLUSIONS: The everolimus-eluting stent was found to be non-inferior to the sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; NCT00552877.
OriginalsprogEngelsk
Sider (fra-til)1246-55
DOI
StatusUdgivet - 2012
Udgivet eksterntJa

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