Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial.

Détails

ID Serval
serval:BIB_73A85874C197
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial.
Périodique
Lancet
Auteur(s)
Pilgrim T., Piccolo R., Heg D., Roffi M., Tüller D., Muller O., Moarof I., Siontis GCM, Cook S., Weilenmann D., Kaiser C., Cuculi F., Hunziker L., Eberli F.R., Jüni P., Windecker S.
ISSN
1474-547X (Electronic)
ISSN-L
0140-6736
Statut éditorial
Publié
Date de publication
01/09/2018
Peer-reviewed
Oui
Volume
392
Numéro
10149
Pages
737-746
Langue
anglais
Notes
Publication types: Comparative Study ; Equivalence Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes.
In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104.
2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88-1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06-1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51-2·05; p=0·950).
5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials.
Clinical Trials Unit of the University of Bern and Biotronik.
Mots-clé
Absorbable Implants, Acute Coronary Syndrome/complications, Acute Coronary Syndrome/mortality, Acute Coronary Syndrome/surgery, Adult, Aged, Aged, 80 and over, Cause of Death, Coronary Artery Disease/complications, Coronary Artery Disease/mortality, Coronary Artery Disease/surgery, Drug-Eluting Stents/adverse effects, Everolimus/administration & dosage, Female, Follow-Up Studies, Humans, Immunosuppressive Agents/administration & dosage, Intention to Treat Analysis, Male, Middle Aged, Myocardial Infarction/etiology, Myocardial Infarction/mortality, Percutaneous Coronary Intervention/instrumentation, Polymers, Prosthesis Design, Prosthesis Failure/etiology, Single-Blind Method, Sirolimus/administration & dosage, Thrombosis/etiology, Treatment Outcome
Pubmed
Web of science
Création de la notice
10/09/2018 16:24
Dernière modification de la notice
20/08/2019 15:31
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