Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials

Summary Background The safety and efficacy of drug-eluting stents (DES) in the treatment of coronary artery disease have been assessed in several randomised trials. However, none of these trials were powered to assess the safety and efficacy of DES in women because only a small proportion of recruit...

Full description

Saved in:
Bibliographic Details
Published in:The Lancet (British edition) 2013-12, Vol.382 (9908), p.1879-1888
Main Authors: Stefanini, Giulio G, MD, Baber, Usman, MD, Windecker, Stephan, Prof, Morice, Marie-Claude, MD, Sartori, Samantha, PhD, Leon, Martin B, Prof, Stone, Gregg W, Prof, Serruys, Patrick W, Prof, Wijns, William, MD, Weisz, Giora, MD, Camenzind, Edoardo, MD, Steg, Philippe G, Prof, Smits, Pieter C, MD, Kandzari, David, MD, Von Birgelen, Clemens, MD, Galatius, Søren, MD, Jeger, Raban V, MD, Kimura, Takeshi, Prof, Mikhail, Ghada W, MD, Itchhaporia, Dipti, MD, Mehta, Laxmi, MD, Ortega, Rebecca, MHA, Kim, Hyo-Soo, MD, Valgimigli, Marco, MD, Kastrati, Adnan, Prof, Chieffo, Alaide, MD, Mehran, Roxana, Dr Prof
Format: Article
Language:English
Subjects:
Acute coronary syndromes
Biological and medical sciences
Cardiovascular disease
coronary artery disease
Coronary Artery Disease - mortality
Coronary Artery Disease - therapy
Coronary Restenosis - epidemiology
Coronary Restenosis - therapy
Coronary vessels
death
Drug-Eluting Stents - adverse effects
Female
Gender
General aspects
Heart attacks
Humans
Internal Medicine
Medical sciences
multivariate analysis
myocardial infarction
Myocardial Infarction - etiology
Myocardial Infarction - mortality
Patients
Percutaneous Coronary Intervention - instrumentation
Percutaneous Coronary Intervention - methods
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Random variables
Randomized Controlled Trials as Topic
Sex Factors
Stents
Studies
Thrombosis
Thrombosis - etiology
Thrombosis - mortality
Treatment Outcome
women
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Summary Background The safety and efficacy of drug-eluting stents (DES) in the treatment of coronary artery disease have been assessed in several randomised trials. However, none of these trials were powered to assess the safety and efficacy of DES in women because only a small proportion of recruited participants were women. We therefore investigated the safety and efficacy of DES in female patients during long-term follow-up. Methods We pooled patient-level data for female participants from 26 randomised trials of DES and analysed outcomes according to stent type (bare-metal stents, early-generation DES, and newer-generation DES). The primary safety endpoint was a composite of death or myocardial infarction. The secondary safety endpoint was definite or probable stent thrombosis. The primary efficacy endpoint was target-lesion revascularisation. Analysis was by intention to treat. Findings Of 43 904 patients recruited in 26 trials of DES, 11 557 (26·3%) were women (mean age 67·1 years [SD 10·6]). 1108 (9·6%) women received bare-metal stents, 4171 (36·1%) early-generation DES, and 6278 (54·3%) newer-generation DES. At 3 years, estimated cumulative incidence of the composite of death or myocardial infarction occurred in 132 (12·8%) women in the bare-metal stent group, 421 (10·9%) in the early-generation DES group, and 496 (9·2%) in the newer-generation DES group (p=0·001). Definite or probable stent thrombosis occurred in 13 (1·3%), 79 (2·1%), and 66 (1·1%) women in the bare-metal stent, early-generation DES, and newer-generation DES groups, respectively (p=0·01). The use of DES was associated with a significant reduction in the 3 year rates of target-lesion revascularisation (197 [18·6%] women in the bare-metal stent group, 294 [7·8%] in the early-generation DES group, and 330 [6·3%] in the newer-generation DES group, p
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(13)61782-1