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

Stefanini, Giulio; Baber, Usman; Windecker, Stephan; Morice, Marie-Claude; Sartori, Samantha; Leon, Martin B; Stone, Gregg W; Serruys, Patrick W; Wijns, William; Weisz, Giora; Camenzind, Edoardo; Steg, Philippe G; Smits, Pieter C; Kandzari, David; Von Birgelen, Clemens; Galatius, Søren; Jeger, Raban V; Kimura, Takeshi; Mikhail, Ghada W; Itchhaporia, Dipti; ... (2013). Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials. Lancet, 382(9908), pp. 1879-1888. Elsevier 10.1016/S0140-6736(13)61782-1

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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<0·0001). Results did not change after adjustment for baseline characteristics in the multivariable analysis. INTERPRETATION The use of DES in women is more effective and safe than is use of bare-metal stents during long-term follow-up. Newer-generation DES are associated with an improved safety profile compared with early-generation DES, and should therefore be thought of as the standard of care for percutaneous coronary revascularisation in women. FUNDING Women in Innovation Initiative of the Society of Cardiovascular Angiography and Interventions.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Stefanini, Giulio and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0140-6736

Publisher:

Elsevier

Language:

English

Submitter:

Judith Liniger

Date Deposited:

24 Mar 2014 10:29

Last Modified:

28 Oct 2015 11:45

Publisher DOI:

10.1016/S0140-6736(13)61782-1

PubMed ID:

24007976

BORIS DOI:

10.7892/boris.41655

URI:

https://boris.unibe.ch/id/eprint/41655

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