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

• 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; Females; Gender; General aspects; Heart attacks; Humans; Internal Medicine; Lesions; Medical sciences; Metals; 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; Safety; Sex Factors; Stents; Studies; Thromboembolism; Thrombosis; Thrombosis - etiology; Thrombosis - mortality; Treatment Outcome; women
• ISSN: 0140-6736; 1474-547X; 1474-547X
• DOI: 10.1016/S0140-6736(13)61782-1

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