MedStar Authors catalog › Details for: Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.
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Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

by Garcia-Garcia, Hector M; Waksman, Ron.
Citation: ; Lancet. 390(10105):1843-1852, 2017 Oct 21..Journal: Lancet (London, England).Published: 2017ISSN: 0140-6736.Full author list: Kandzari DE; Mauri L; Koolen JJ; Massaro JM; Doros G; Garcia-Garcia HM; Bennett J; Roguin A; Gharib EG; Cutlip DE; Waksman R; BIOFLOW V Investigators.UI/PMID: 28851504.Subject(s): *Absorbable Implants | Bayes Theorem | Coronary Artery Disease/th [Therapy] | Creatine Kinase, MB Form/bl [Blood] | *Drug-Eluting Stents | *Everolimus | Female | Humans | Male | Middle Aged | Myocardial Infarction/ep [Epidemiology] | *Percutaneous Coronary Intervention | Polymers | Prospective Studies | Prosthesis Design | *SirolimusInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleDigital Object Identifier: https://dx.doi.org/10.1016/S0140-6736(17)32249-3 (Click here) Abbreviated citation: ; Lancet. 390(10105):1843-1852, 2017 Oct 21.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007.Abstract: BACKGROUND: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention.Abstract: METHODS: BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 mum) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946.Abstract: FINDINGS: Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6.84 to -0.29, p=0.0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0.0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2.6% [95% credible interval -5.5 to 0.1], non-inferiority margin 3.85%, n=2208).Abstract: INTERPRETATION: The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology.Abstract: FUNDING: BIOTRONIK. Copyright (c) 2017 Elsevier Ltd. All rights reserved.

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