دورية أكاديمية
أعرض في EDS

Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial.

التفاصيل البيبلوغرافية
العنوان: Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial.
المؤلفون: Varenne O; Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France; Cardiology Department, Université Paris Descartes, Sorbonne Paris-Cité, Paris, France. Electronic address: olivier.varenne@aphp.fr., Cook S; Cardiology Department, University and Hospital Fribourg, Fribourg, Switzerland., Sideris G; Service de Cardiologie-Institut national de la santé et de la recherche médicale U942, Hôpital Lariboisiere, Assistance Publique - Hôpitaux de Paris, Université Paris Diderot, Paris, France., Kedev S; Cardiology Department, University St Cyril and Methodius, Skopje, Macedonia., Cuisset T; Département de Cardiologie, Centre hospitalier universitaire Timone, Marseille, France., Carrié D; Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France., Hovasse T; Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France., Garot P; Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France., El Mahmoud R; Hôpital Ambroise Paré Assistance Publique-Hôpitaux de Paris, Université Versailles-Saint Quentin en Yvelines, Versailles, France., Spaulding C; Service de Cardiologie, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris Descartes University and Sudden Death Expert Center, Institut national de la santé et de la recherche médicale U990, Paris, France., Helft G; Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie et Institut hospitalo-universitaire, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France., Diaz Fernandez JF; Juan Ramón Jiménez University Hospital, Huelva, Spain., Brugaletta S; Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain., Pinar-Bermudez E; Hospital Universitario Virgen de la Arrixaca, Murcia, Spain., Mauri Ferre J; Hospital Universitari Germans Trias i Pujol, Badalona, Spain., Commeau P; Département de Cardiologie Interventionnelle, Polyclinique Les Fleurs, Ollioules, France., Teiger E; Service de Cardiologie, Hôpital Henri Mondor Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France., Bogaerts K; Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), Department of Public Health and Primary Care, Katholieke Universiteit Leuven, Leuven, Belgium; Interuniversity Institute for Biostatistics and Statistical Bioinformatics (I-BioStat), University Hasselt, Hasselt, Belgium., Sabate M; Interventional Cardiology Unit, Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain., Morice MC; Cardiovascular European Research Center, Massy, France., Sinnaeve PR; Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.
مؤلفون مشاركون: SENIOR investigators
المصدر: Lancet (London, England) [Lancet] 2018 Jan 06; Vol. 391 (10115), pp. 41-50. Date of Electronic Publication: 2017 Nov 01.
نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE
أسماء مطبوعة: Publication: 2004- : London : Elsevier
Original Publication: London : J. Onwhyn
مواضيع طبية MeSH: Drug-Eluting Stents* , Percutaneous Coronary Intervention*, Coronary Artery Disease/*therapy, Age Factors ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Platelet Aggregation Inhibitors/therapeutic use ; Single-Blind Method ; Treatment Outcome
مستخلص: Background: Elderly patients regularly receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of double antiplatelet therapy (DAPT). The aim of this study was to compare outcomes between these two types of stents with a short duration of DAPT in such patients.
Methods: In this randomised single-blind trial, we recruited patients from 44 centres in nine countries. Patients were eligible if they were aged 75 years or older; had stable angina, silent ischaemia, or an acute coronary syndrome; and had at least one coronary artery with a stenosis of at least 70% (≥50% for the left main stem) deemed eligible for percutaneous coronary intervention (PCI). Exclusion criteria were indication for myocardial revascularisation by coronary artery bypass grafting; inability to tolerate, obtain, or comply with DAPT; requirement for additional surgery; non-cardiac comorbidities with a life expectancy of less than 1 year; previous haemorrhagic stroke; allergy to aspirin or P2Y 12 inhibitors; contraindication to P2Y 12 inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0·80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked. The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year. This trial is registered with ClinicalTrials.gov, number NCT02099617.
Findings: Between May 21, 2014, and April 16, 2016, we randomly assigned 1200 patients (596 [50%] to the DES group and 604 [50%] to the BMS group). The primary endpoint occurred in 68 (12%) patients in the DES group and 98 (16%) in the BMS group (relative risk [RR] 0·71 [95% CI 0·52-0·94]; p=0·02). Bleeding complications (26 [5%] in the DES group vs 29 [5%] in the BMS group; RR 0·90 [0·51-1·54]; p=0·68) and stent thrombosis (three [1%] vs eight [1%]; RR 0·38 [0·00-1·48]; p=0·13) at 1 year were infrequent in both groups.
Interpretation: Among elderly patients who have PCI, a DES and a short duration of DAPT are better than BMS and a similar duration of DAPT with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischaemia-driven target lesion revascularisation. A strategy of combination of a DES to reduce the risk of subsequent repeat revascularisations with a short BMS-like DAPT regimen to reduce the risk of bleeding event is an attractive option for elderly patients who have PCI.
Funding: Boston Scientific.
(Copyright © 2018 Elsevier Ltd. All rights reserved.)
التعليقات: Comment in: Lancet. 2018 Jan 6;391(10115):4-6. (PMID: 29102363)
سلسلة جزيئية: ClinicalTrials.gov NCT02099617
المشرفين على المادة: 0 (Platelet Aggregation Inhibitors)
تواريخ الأحداث: Date Created: 20171106 Date Completed: 20180329 Latest Revision: 20180329
رمز التحديث: 20240628
DOI: 10.1016/S0140-6736(17)32713-7
PMID: 29102362
قاعدة البيانات: MEDLINE
الوصف
تدمد:1474-547X
DOI:10.1016/S0140-6736(17)32713-7