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June 9, 2013 at 3:36 am #1648AnonymousInactive
The Lancet, Early Online Publication, 2 September 2013
Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials
Giulio G Stefanini MD a †, Usman Baber MD b †, Prof Stephan Windecker MD a, Marie-Claude Morice MD v, Samantha Sartori PhD b, Prof Martin B Leon MD c, Prof Gregg W Stone MD c, Prof Patrick W Serruys MD q, William Wijns MD d, Giora Weisz MD c, Edoardo Camenzind MD e, Prof Philippe G Steg MD g, Peter C Smits MD h, David Kandzari MD j, Clemens Von Birgelen MD i, Søren Galatius MD k, Raban V Jeger MD f, Prof Takeshi Kimura MD l, Ghada Mikhail MD m, Dipti Itchhaporia MD r, Laxmi Mehta MD t, Rebecca Ortega MHA s, Hyo-Soo Kim MD n, Marco Valgimigli MD o, Prof Adnan Kastrati MD p, Alaide Chieffo MD u, Dr Prof Roxana Mehran MD b Corresponding AuthorEmail Address
SummaryBackground
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.
FindingsOf 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.
InterpretationThe 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.
G Mohan.
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