TY - JOUR
T1 - Safety and effi cacy of drug-eluting stents in women
T2 - A patient-level pooled analysis of randomised trials
AU - Stefanini, Giulio G.
AU - Baber, Usman
AU - Windecker, Stephan
AU - Morice, Marie Claude
AU - Sartori, Samantha
AU - Leon, Martin B.
AU - Stone, Gregg W.
AU - Serruys, Patrick W.
AU - Wijns, William
AU - Weisz, Giora
AU - Camenzind, Edoardo
AU - Steg, Philippe G.
AU - Smits, Pieter C.
AU - Kandzari, David
AU - Von Birgelen, Clemens
AU - Galatius, Soren
AU - Jeger, Raban V.
AU - Kimura, Takeshi
AU - Mikhail, Ghada W.
AU - Itchhaporia, Dipti
AU - Mehta, Laxmi
AU - Ortega, Rebecca
AU - Kim, Hyo Soo
AU - Valgimigli, Marco
AU - Kastrati, Adnan
AU - Chieffo, Alaide
AU - Mehran, Roxana
N1 - Funding Information:
The Gender Data Forum was sponsored by the Women in Innovation Initiative of the Society of Cardiovascular Angiography and Interventions.
PY - 2013
Y1 - 2013
N2 - Background The safety and effi cacy 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 effi cacy of DES in women because only a small proportion of recruited participants were women. We therefore investigated the safety and effi cacy 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 defi nite or probable stent thrombosis. The primary effi cacy 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%) newergeneration 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). Defi nite 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 signifi cant reduction in the 3 year rates of targetlesion 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 longterm follow-up. Newer-generation DES are associated with an improved safety profi le compared with earlygeneration DES, and should therefore be thought of as the standard of care for percutaneous coronary revascularisation in women.
AB - Background The safety and effi cacy 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 effi cacy of DES in women because only a small proportion of recruited participants were women. We therefore investigated the safety and effi cacy 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 defi nite or probable stent thrombosis. The primary effi cacy 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%) newergeneration 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). Defi nite 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 signifi cant reduction in the 3 year rates of targetlesion 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 longterm follow-up. Newer-generation DES are associated with an improved safety profi le compared with earlygeneration DES, and should therefore be thought of as the standard of care for percutaneous coronary revascularisation in women.
UR - http://www.scopus.com/inward/record.url?scp=84889264879&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(13)61782-1
DO - 10.1016/S0140-6736(13)61782-1
M3 - Article
C2 - 24007976
AN - SCOPUS:84889264879
SN - 0140-6736
VL - 382
SP - 1879
EP - 1888
JO - The Lancet
JF - The Lancet
IS - 9908
ER -