Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease
| Autor: | Stuart J. Connolly, Jackie Bosch, Yan Liang, Lars Keller, Eva Muehlhofer, Gilles R. Dagenais, Lisheng Liu, Scott D. Berkowitz, Tomasz J. Guzik, Compass Trial Investigators, Martin O'Donnell, Jun Zhu, Olga Shestakovska, Sonia S. Anand, John W. Eikelboom, Keith A.A. Fox, Salim Yusuf |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Physiology Myocardial Infarction Hemorrhage Comorbidity Coronary Artery Disease 030204 cardiovascular system & hematology Risk Assessment Drug Administration Schedule Coronary artery disease Peripheral Arterial Disease 03 medical and health sciences Sex Factors 0302 clinical medicine Double-Blind Method Rivaroxaban Risk Factors Physiology (medical) Internal medicine medicine Humans 030212 general & internal medicine Myocardial infarction Aged Aged 80 and over Aspirin Framingham Risk Score Proportional hazards model business.industry Hazard ratio Health Status Disparities Middle Aged medicine.disease Stroke Treatment Outcome Drug Therapy Combination Female Cardiology and Cardiovascular Medicine business Platelet Aggregation Inhibitors Mace Factor Xa Inhibitors medicine.drug |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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