Yan Liang1, Jun Zhu1, Lisheng Liu1, Sonia S Anand2,3, Stuart J Connolly2,4, Jackie Bosch5, Tomasz J Guzik6,7, Martin O'Donnell8, Gilles R Dagenais9, Keith Aa Fox10,11, Olga Shestakovska5, Scott D Berkowitz12, Eva Muehlhofer13, Lars Keller14, Salim Yusuf2,5,15, John W Eikelboom2,5,16. 1. Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases, No. 167, Beilishi Road, Xicheng District, Beijing 100037, China. 2. Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. 3. Department of Epidemiology, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. 4. Division of Cardiology, Department of Medicine, Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. 5. Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. 6. Institute of Cardiovascular & Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. 7. Collegium Medicum, Jagiellonian University, Krakow, Poland. 8. Department of Translational Medicine, NUI Galway and Saolta Hospital Group, HRB-Clinical Research Facility, Galway, Ireland. 9. Department of Medicine, Laval University and Quebec Heart and Lung Institute, Quebec City, Canada. 10. Department of Cardiology, University of Edinburgh, Edinburgh, UK. 11. Department of Medical and Radiological Sciences, Royal Infirmary of Edinburgh, Edinburgh, UK. 12. Clinical Development, Group Head Thrombosis, Bayer U.S. LLC, Research & Development, Pharmaceuticals, Thrombosis & Hematology Therapeutic Area, Whippany, NJ, USA. 13. Bayer AG, Research & Development, Pharmaceuticals, TA Thrombosis & Hematology, USA. 14. Bayer AG, Research & Development, Pharmaceuticals, Medical Experts Cardio & Coagulant, USA. 15. Heart and Stroke Foundation/Marion W. Burke Chair in Cardiovascular Disease, Hamilton Health Sciences, Hamilton, Ontario, Canada. 16. Hamilton General Hospital, Hamilton, Ontario, Canada.
Abstract
AIMS: The COMPASS trial demonstrated that the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced major adverse cardiovascular events (MACE) in patients with chronic coronary artery disease or peripheral artery disease by 24% during a mean follow-up of 23 months. We explored whether this effect varies by sex. METHODS AND RESULTS: The effects were examined in women and men using log-rank tests and Kaplan-Meier curve. Hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were obtained from stratified Cox proportional hazards models to explore subgroup effects including subgroup of women and men according to baseline modified REACH risk score. Of 27 395 patients randomized, 18 278 were allocated to receive rivaroxaban plus aspirin (n = 9152) or aspirin alone (n = 9126), and of these, 22.1% were women. Women compared with men had similar incidence rates for MACE and major bleeding but borderline lower rates for myocardial infarction (1.7% vs. 2.2%, P = 0.05). The effect of combination therapy compared with aspirin in women and men was consistent for MACE (women: 3.8% vs. 5.2%, HR 0.72, 95% CI 0.54-0.97; men: 4.2% vs. 5.5%, HR 0.76, 95% CI 0.66-0.89; P interaction 0.75) and major bleeding (women: 3.1% vs. 1.4%, HR 2.22, 95% CI 1.42-3.46; men: 3.2% vs. 2.0%, HR 1.60, 95% CI 1.29-1.97; P interaction 0.19). There was no significant interaction between randomized treatment and baseline modified REACH score above or below the median for MACE or major bleeding. CONCLUSION: In patients with stable coronary artery disease or peripheral artery disease, the combination of rivaroxaban (2.5 mg twice daily) and aspirin compared with aspirin alone appears to produce consistent benefits in women and men, independent of baseline cardiovascular risk. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The COMPASS trial demonstrated that the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced major adverse cardiovascular events (MACE) in patients with chronic coronary artery disease or peripheral artery disease by 24% during a mean follow-up of 23 months. We explored whether this effect varies by sex. METHODS AND RESULTS: The effects were examined in women and men using log-rank tests and Kaplan-Meier curve. Hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were obtained from stratified Cox proportional hazards models to explore subgroup effects including subgroup of women and men according to baseline modified REACH risk score. Of 27 395 patients randomized, 18 278 were allocated to receive rivaroxaban plus aspirin (n = 9152) or aspirin alone (n = 9126), and of these, 22.1% were women. Women compared with men had similar incidence rates for MACE and major bleeding but borderline lower rates for myocardial infarction (1.7% vs. 2.2%, P = 0.05). The effect of combination therapy compared with aspirin in women and men was consistent for MACE (women: 3.8% vs. 5.2%, HR 0.72, 95% CI 0.54-0.97; men: 4.2% vs. 5.5%, HR 0.76, 95% CI 0.66-0.89; P interaction 0.75) and major bleeding (women: 3.1% vs. 1.4%, HR 2.22, 95% CI 1.42-3.46; men: 3.2% vs. 2.0%, HR 1.60, 95% CI 1.29-1.97; P interaction 0.19). There was no significant interaction between randomized treatment and baseline modified REACH score above or below the median for MACE or major bleeding. CONCLUSION: In patients with stable coronary artery disease or peripheral artery disease, the combination of rivaroxaban (2.5 mg twice daily) and aspirin compared with aspirin alone appears to produce consistent benefits in women and men, independent of baseline cardiovascular risk. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Connie N Hess; Iris Baumgartner; Sonia S Anand; Mark R Nehler; Manesh R Patel; E Sebastian Debus; Michael Szarek; Warren Capell; Eva Muehlhofer; Scott D Berkowitz; Lloyd P Haskell; Rupert M Bauersachs; Marc P Bonaca; Judith Hsia Journal: J Am Heart Assoc Date: 2022-06-14 Impact factor: 6.106
Authors: Maria Pabon; Susan Cheng; S Elissa Altin; Sanjum S Sethi; Michael D Nelson; Kerrie L Moreau; Naomi Hamburg; Connie N Hess Journal: Circ Res Date: 2022-02-17 Impact factor: 23.213