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Lancet. 2013 Feb 23;381(9867):661-9. doi: 10.1016/S0140-6736(12)61962-X. Epub 2013 Jan 30.

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial.

Author information

  • 1Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. evald.christiansen@dadlnet.dk

Erratum in

  • Lancet. 2013 Jul 27;382(9889):310. Noergaard, Bjarne Linde [corrected to Norgaard, Bjarne Linde].

Abstract

BACKGROUND:

Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting.

METHODS:

FINDINGS:

From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk difference 0·6% [95% CI 0·0-1·1]; p=0·034). Per-protocol analysis showed that 45 (3·8%) of 1193 patients who received a biolimus-eluting stent and 39 (3·2%) of 1208 who received a sirolimus-eluting stent met the primary endpoint (risk difference 0·5% [upper limit of one-sided 95% CI 1·8%]; p(non-inferiority)=0·03).

INTERPRETATION:

At 1 year follow-up, the biodegradable polymer biolimus-eluting Nobori stent did not improve clinical results compared with a first-generation sirolimus-eluting stent. We will need to obtain long-term data before we can make recommendations for the role of this biolimus-eluting stent in routine clinical practice.

FUNDING:

Terumo and Cordis (Johnson & Johnson).

Copyright © 2013 Elsevier Ltd. All rights reserved.

PMID:
23374649
[PubMed - indexed for MEDLINE]
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