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

Summary 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...

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Published in:The Lancet (British edition) 2013-02, Vol.381 (9867), p.661-669
Main Authors: Christiansen, Evald Høj, Dr, Jensen, Lisette Okkels, DMSci, Thayssen, Per, DMSci, Tilsted, Hans-Henrik, MD, Krusell, Lars Romer, MD, Hansen, Knud Nørregaard, MD, Kaltoft, Anne, PhD, Maeng, Michael, PhD, Kristensen, Steen Dalby, Prof, Bøtker, Hans Erik, Prof, Terkelsen, Christian Juhl, DMSci, Villadsen, Anton Boel, MD, Ravkilde, Jan, DMSci, Aarøe, Jens, MD, Madsen, Morten, MSc, Thuesen, Leif, DMSci, Lassen, Jens Flensted, PhD
Format: Article
Language:English
Subjects:
Absorbable Implants
Acute Coronary Syndrome - mortality
Acute Coronary Syndrome - therapy
acute course
Aged
Aspirin - therapeutic use
biodegradability
Biological and medical sciences
Cardiology. Vascular system
Cardiovascular disease
Coated Materials, Biocompatible
coronary artery disease
Coronary Artery Disease - mortality
Coronary Artery Disease - therapy
Coronary heart disease
Coronary Thrombosis - epidemiology
Coronary Thrombosis - etiology
Coronary vessels
death
Diseases of the cardiovascular system
Drug therapy
Drug-Eluting Stents - adverse effects
Female
General aspects
Heart
Heart attacks
Humans
Internal Medicine
Male
Medical sciences
Mortality
myocardial infarction
Myocardial Infarction - epidemiology
patients
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors - therapeutic use
Polymers
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Retreatment - statistics & numerical data
risk
Sirolimus - analogs & derivatives
Sirolimus - therapeutic use
Stents
thrombosis
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Summary:Summary 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 This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov , number NCT01254981. 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%]; pnon-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%]; pnon-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 sirolim
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(12)61962-X