title: Safety and efficacy of drug-eluting stents in women: a patient-level pooled analysis of randomised trials.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Women in Innovation Initiative of the Society of Cardiovascular Angiography and Interventions.
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.forename: Usman
authors.initials: U
authors.lastname: Baber
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Samantha
authors.initials: S
authors.lastname: Sartori
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
authors.forename: Philippe G
authors.initials: PG
authors.lastname: Steg
authors.forename: Pieter C
authors.initials: PC
authors.lastname: Smits
authors.forename: David
authors.initials: D
authors.lastname: Kandzari
authors.forename: Clemens
authors.initials: C
authors.lastname: Von Birgelen
authors.forename: Søren
authors.initials: S
authors.lastname: Galatius
authors.forename: Raban V
authors.initials: RV
authors.lastname: Jeger
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Ghada W
authors.initials: GW
authors.lastname: Mikhail
authors.forename: Dipti
authors.initials: D
authors.lastname: Itchhaporia
authors.forename: Laxmi
authors.initials: L
authors.lastname: Mehta
authors.forename: Rebecca
authors.initials: R
authors.lastname: Ortega
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
mesh_terms: D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000628:therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D013927:Thrombosis / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome