Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study): A multicentre, open-label, randomised superiority trial

Michael Maeng*, Hans Henrik Tilsted, Lisette Okkels Jensen, Lars Romer Krusell, Anne Kaltoft, Henning Kelbæk, Anton B. Villadsen, Jan Ravkilde, Knud Nørregaard Hansen, Evald Høj Christiansen, Jens Aarøe, Jan Skov Jensen, Steen Dalby Kristensen, Hans Erik Bøtker, Leif Thuesen, Morten Madsen, Per Thayssen, Henrik Toft Sørensen, Jens Flensted Lassen

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstract

Background: In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents. Methods: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478. Findings: We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17·0%] vs sirolimus-eluting stents 182/1170 [15·6%]; odds ratio [OR] 1·10, 95% CI 0·88-1·37; p=0·40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8·0%] vs sirolimus 46/1170 [3·9%]; OR 2·13, 95% CI 1·48-3·07; p<0·0001) compared with those at follow-up between 1 and 5 years (104 [9·0%] vs 136 [11·6%]; OR 0·78, 95% CI 0·59- 1·02; p=0·071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1·1%]) than the sirolimus-eluting stent (4/1170 [0·3%]; OR 3·34, 95% CI 1·08-10·3; p=0·036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0·1%] vs sirolimus-eluting stent 21/1170 [1·8%], OR 0·05, 95% CI 0·01-0·36; p=0·003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period. Interpretation: The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation. Funding: Cordis and Medtronic.

OriginalsprogEngelsk
Sider (fra-til)2047-2056
Antal sider10
TidsskriftThe Lancet
Vol/bind383
Udgave nummer9934
DOI
StatusUdgivet - 1 jan. 2014
Udgivet eksterntJa

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