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Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.

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

Author information

1
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.
2
Cardiology Department, University and Hospital Fribourg, Fribourg, Switzerland.
3
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.
4
Cardiology Department, University St Cyril and Methodius, Skopje, Macedonia.
5
Département de Cardiologie, Centre hospitalier universitaire Timone, Marseille, France.
6
Service de Cardiologie, Centre hospitalier universitaire Toulouse Rangueil, Université Paul Sabatier, Toulouse, France.
7
Institut Cardiovasculaire Paris-Sud, Ramsay Générale de Santé, Massy and Quincy, France.
8
Hôpital Ambroise Paré Assistance Publique-Hôpitaux de Paris, Université Versailles-Saint Quentin en Yvelines, Versailles, France.
9
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.
10
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.
11
Juan Ramón Jiménez University Hospital, Huelva, Spain.
12
Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
13
Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
14
Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
15
Département de Cardiologie Interventionnelle, Polyclinique Les Fleurs, Ollioules, France.
16
Service de Cardiologie, Hôpital Henri Mondor Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France.
17
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.
18
Interventional Cardiology Unit, Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
19
Cardiovascular European Research Center, Massy, France.
20
Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.

Abstract

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 P2Y12 inhibitors; contraindication to P2Y12 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.

PMID:
29102362
DOI:
10.1016/S0140-6736(17)32713-7
[Indexed for MEDLINE]

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