دورية أكاديمية

Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy.

التفاصيل البيبلوغرافية
العنوان: Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy.
المؤلفون: Kereiakes DJ; The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, Ohio. Electronic address: lindner@thechristhospital.com., Ellis SG; Cleveland Clinic, Cleveland, Ohio., Kimura T; Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan., Abizaid A; Institute Dante Pazzanese of Cardiology, São Paulo, Brazil., Zhao W; Abbott Vascular, Santa Clara, California., Veldhof S; Abbott Vascular, Santa Clara, California., Vu MT; Abbott Vascular, Santa Clara, California., Zhang Z; Abbott Vascular, Santa Clara, California., Onuma Y; Thorax Centre, Erasmus MC, Rotterdam, the Netherlands., Chevalier B; Institut Jacques Cartier, Massy, France., Serruys PW; International Centre for Cardiovascular Health, Imperial College, London, United Kingdom., Stone GW; New York Presbyterian Hospital, Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
المصدر: JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2017 Jan 09; Vol. 10 (1), pp. 42-49. Date of Electronic Publication: 2016 Dec 21.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE
أسماء مطبوعة: Original Publication: New York : Elsevier
مواضيع طبية MeSH: Absorbable Implants* , Coated Materials, Biocompatible* , Diabetes Mellitus*/diagnosis , Diabetes Mellitus*/drug therapy, Cardiovascular Agents/*administration & dosage , Coronary Artery Disease/*therapy , Everolimus/*administration & dosage , Percutaneous Coronary Intervention/*instrumentation, Age Factors ; Aged ; Cardiovascular Agents/adverse effects ; Chi-Square Distribution ; Coronary Artery Disease/diagnostic imaging ; Coronary Thrombosis/etiology ; Everolimus/adverse effects ; Female ; Humans ; Hypoglycemic Agents/therapeutic use ; Insulin/therapeutic use ; Male ; Middle Aged ; Multivariate Analysis ; Percutaneous Coronary Intervention/adverse effects ; Proportional Hazards Models ; Prosthesis Design ; Randomized Controlled Trials as Topic ; Registries ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome
مستخلص: Objectives: The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus.
Background: Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population.
Methods: In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year following Absorb BVS compared with a performance goal of 12.7%.
Results: Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF.
Conclusions: The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
(Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
التعليقات: Comment in: JACC Cardiovasc Interv. 2017 Jan 9;10(1):50-52. (PMID: 28017312)
فهرسة مساهمة: Keywords: bioresorbable vascular scaffolds; coronary artery disease; diabetes
المشرفين على المادة: 0 (Cardiovascular Agents)
0 (Coated Materials, Biocompatible)
0 (Hypoglycemic Agents)
0 (Insulin)
9HW64Q8G6G (Everolimus)
تواريخ الأحداث: Date Created: 20161227 Date Completed: 20170925 Latest Revision: 20181014
رمز التحديث: 20221213
DOI: 10.1016/j.jcin.2016.10.019
PMID: 28017311
قاعدة البيانات: MEDLINE
الوصف
تدمد:1876-7605
DOI:10.1016/j.jcin.2016.10.019