MedStar Authors catalog › Details for: Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial.
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Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial.

by Garcia-Garcia, Hector M; Waksman, Ron.
Citation: Jacc: Cardiovascular Interventions. 13(11):1343-1353, 2020 06 08.; .Journal: JACC. Cardiovascular interventions.Published: 2020; ; ; ISSN: 1936-8798.Full author list: Bennett J; BIOFLOW V Investigators; Cutlip DE; Doros G; Garcia-Garcia HM; Gharib EG; Kandzari DE; Koolen JJ; Roguin A; Waksman R.UI/PMID: 32499026.Subject(s): *Absorbable Implants | *Cardiovascular Agents/ad [Administration & Dosage] | *Coronary Artery Disease/th [Therapy] | *Drug-Eluting Stents | *Everolimus/ad [Administration & Dosage] | *Percutaneous Coronary Intervention/is [Instrumentation] | *Sirolimus/ad [Administration & Dosage] | Aged | Cardiovascular Agents/ae [Adverse Effects] | Coronary Artery Disease/dg [Diagnostic Imaging] | Coronary Artery Disease/mo [Mortality] | Everolimus/ae [Adverse Effects] | Female | Humans | Male | Middle Aged | Percutaneous Coronary Intervention/ae [Adverse Effects] | Percutaneous Coronary Intervention/mo [Mortality] | Prospective Studies | Prosthesis Design | Risk Factors | Sirolimus/ae [Adverse Effects] | Time Factors | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1016/j.jcin.2020.02.019https://dx.doi.org/10.1016/j.jcin.2020.02.019 (Click here) | (Click here) Abbreviated citation: JACC Cardiovasc Interv. 13(11):1343-1353, 2020 06 08; .Abstract: BACKGROUND: Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug- eluting stents, but limited insight exists regarding late-term outcomes.Abstract: CONCLUSIONS: In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946). Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.Abstract: METHODS: BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.Abstract: OBJECTIVES: The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-mum) bioresorbable- polymer sirolimus-eluting stents (BP SES) and thin-strut (81mum) durable-polymer everolimus-eluting stents (DP EES).Abstract: RESULTS: Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.

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