Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents: BIOFLOW V 2-Year Results.

MedStar author(s):
Citation: Journal of the American College of Cardiology. 2018 Sep 19PMID: 30257191Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2018Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007ISSN:
  • 0735-1097
Name of journal: Journal of the American College of CardiologyAbstract: BACKGROUND: Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies.CONCLUSIONS: In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years favoring treatment with BP SES over DP EES. Significantly lower cumulative TLR and late/very late stent thrombosis were also observed with BP SES.Copyright (c) 2018. Published by Elsevier Inc.METHODS: BIOFLOW V was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed.OBJECTIVES: To compare late-term clinical outcomes among patients treated with an ultrathin strut (60 mum) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 mum) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial.RESULTS: Among 1,334 patients randomized to treatment with BP SES (884 patients) or DP EES (450 patients), the two-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference, 95% CI -8.16% to -0.91%, P=0.015), driven by differences in target vessel myocardial infarction (MI; 5.3% versus 9.5%, P=0.01) and ischemia-driven target lesion revascularization (TLR; 2.6% versus 4.9%, P=0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (P=0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% versus 1.0%, P=0.045).All authors: Bennett J, BIOFLOW V Investigators, Cutlip DE, Doros G, Garcia-Garcia HM, Gharib EG, Kandzari DE, Koolen JJ, Massaro JJ, Roguin A, Waksman RFiscal year: FY2019Digital Object Identifier: Date added to catalog: 2018-10-10
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30257191 Available 30257191

Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007

BACKGROUND: Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies.

CONCLUSIONS: In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years favoring treatment with BP SES over DP EES. Significantly lower cumulative TLR and late/very late stent thrombosis were also observed with BP SES.

Copyright (c) 2018. Published by Elsevier Inc.

METHODS: BIOFLOW V was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed.

OBJECTIVES: To compare late-term clinical outcomes among patients treated with an ultrathin strut (60 mum) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 mum) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial.

RESULTS: Among 1,334 patients randomized to treatment with BP SES (884 patients) or DP EES (450 patients), the two-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference, 95% CI -8.16% to -0.91%, P=0.015), driven by differences in target vessel myocardial infarction (MI; 5.3% versus 9.5%, P=0.01) and ischemia-driven target lesion revascularization (TLR; 2.6% versus 4.9%, P=0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (P=0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% versus 1.0%, P=0.045).

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