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.
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.
Authors: Kelly C Epps; Elizabeth M Holper; Faith Selzer; Helen A Vlachos; Sarah K Gualano; J Dawn Abbott; Alice K Jacobs; Oscar C Marroquin; Srihari S Naidu; Peter W Groeneveld; Robert L Wilensky Journal: Circ Cardiovasc Qual Outcomes Date: 2016-02
Authors: Wayne Batchelor; David E Kandzari; Scott Davis; Luis Tami; John C Wang; Islam Othman; Osvaldo S Gigliotti; Amir Haghighat; Sarabjeet Singh; Mario Lopez; Gregory Giugliano; Phillip A Horwitz; Jaya Chandrasekhar; Paul Underwood; Craig A Thompson; Roxana Mehran Journal: JAMA Cardiol Date: 2017-12-01 Impact factor: 14.676
Authors: Gennaro Giustino; Rafael Harari; Usman Baber; Samantha Sartori; Gregg W Stone; Martin B Leon; Stephan Windecker; Patrick W Serruys; Adnan Kastrati; Clemens Von Birgelen; Takeshi Kimura; Giulio G Stefanini; George D Dangas; William Wijns; P Gabriel Steg; Marie-Claude Morice; Edoardo Camenzind; Giora Weisz; Pieter C Smits; Sabato Sorrentino; Madhav Sharma; Serdar Farhan; Michela Faggioni; David Kandzari; Soren Galatius; Raban V Jeger; Marco Valgimigli; Dipti Itchhaporia; Laxmi Mehta; Hyo-Soo Kim; Alaide Chieffo; Roxana Mehran Journal: JAMA Cardiol Date: 2017-08-01 Impact factor: 14.676
Authors: Anna Franzone; Dik Heg; Lorenz Räber; Marco Valgimigli; Raffaele Piccolo; Thomas Zanchin; Kyohei Yamaji; Stefan Stortecky; Stefan Blöchlinger; Lukas Hunziker; Fabien Praz; Peter Jüni; Stephan Windecker; Thomas Pilgrim Journal: Clin Res Cardiol Date: 2016-04-01 Impact factor: 5.460
Authors: Stephan Windecker; Stefan Stortecky; Giulio G Stefanini; Bruno R da Costa; Bruno R daCosta; Anne Wilhelmina Rutjes; Marcello Di Nisio; Maria G Silletta; Maria G Siletta; Ausilia Maione; Fernando Alfonso; Peter M Clemmensen; Jean-Philippe Collet; Jochen Cremer; Volkmar Falk; Gerasimos Filippatos; Christian Hamm; Stuart Head; Arie Pieter Kappetein; Adnan Kastrati; Juhani Knuuti; Ulf Landmesser; Günther Laufer; Franz-Joseph Neumann; Dimitri Richter; Patrick Schauerte; Miguel Sousa Uva; David P Taggart; Lucia Torracca; Marco Valgimigli; William Wijns; Adam Witkowski; Philippe Kolh; Peter Jüni; Peter Juni Journal: BMJ Date: 2014-06-23