Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor (SPORTIF) trials

Gomberg‐Maitland, Mardi; Wenger, Nanette K.; Feyzi, Jan; Lengyel, M; Volgman, Annabelle Santos; Petersen, Palle; Frison, Lars; Halperin, Jonathan L.

doi:10.1093/eurheartj/ehl103

Cited by 91 publications

(58 citation statements)

References 23 publications

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“…1,2 Anticoagulation with warfarin reduces the risk of ischemic stroke, 3 and the net benefit of warfarin rises with age. 4 The risk of bleeding during anticoagulant therapy is also Background-Nonvalvular atrial fibrillation is common in elderly patients, who face an elevated risk of stroke but difficulty sustaining warfarin treatment.…”

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confidence: 99%

Efficacy and Safety of Rivaroxaban Compared With Warfarin Among Elderly Patients With Nonvalvular Atrial Fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)

et al. 2014

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T he prevalence of atrial fibrillation (AF) increases with age 1 and is a major cause of stroke, disability, and death among the elderly, particularly among older women. 1,2 Anticoagulation with warfarin reduces the risk of ischemic stroke, 3 and the net benefit of warfarin rises with age. 4 The risk of bleeding during anticoagulant therapy is also Background-Nonvalvular atrial fibrillation is common in elderly patients, who face an elevated risk of stroke but difficulty sustaining warfarin treatment. The oral factor Xa inhibitor rivaroxaban was noninferior to warfarin in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). This prespecified secondary analysis compares outcomes in older and younger patients. Methods and Results-There were 6229 patients (44%) aged ≥75 years with atrial fibrillation and ≥2 stroke risk factors randomized to warfarin (target international normalized ratio=2.0-3.0) or rivaroxaban (20 mg daily; 15 mg if creatinine clearance <50 mL/min), double blind. The primary end point was stroke and systemic embolism by intention to treat. Over 10 866 patient-years, older participants had more primary events (2.57% versus 2.05%/100 patient-years; P=0.0068) and major bleeding (4.63% versus 2.74%/100 patient-years; P<0.0001). Stroke/systemic embolism rates were consistent among older (2.29% rivaroxaban versus 2.85% warfarin per 100 patient-years; hazard ratio=0.80; 95% confidence interval, 0.63-1.02) and younger patients (2.00% versus 2.10%/100 patient-years; hazard ratio=0.95; 95% confidence interval, 0.76-1.19; interaction P=0.313), as were major bleeding rates (≥75 years: 4.86% rivaroxaban versus 4.40% warfarin per 100 patient-years; hazard ratio=1.11; 95% confidence interval, 0.92-1.34; <75 years: 2.69% versus 2.79%/100 patient-years; hazard ratio=0.96; 95% confidence interval, 0.78-1.19; interaction P=0.336). Hemorrhagic stroke rates were similar in both age groups; there was no interaction between age and rivaroxaban response. Conclusions-Elderly patients had higher stroke and major bleeding rates than younger patients, but the efficacy and safety of rivaroxaban relative to warfarin did not differ with age, supporting rivaroxaban as an alternative for the elderly.

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Efficacy and Safety of Rivaroxaban Compared With Warfarin Among Elderly Patients With Nonvalvular Atrial Fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)

et al. 2014

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“…22 Also, no significant sex differences in anticoagulation-related major bleeding are evident. 23 Despite comparable or greater comorbidities, elderly women (aged ≥75 years) had similar rates of anticoagulationrelated major bleeding compared with younger women (aged <75 years), arguing for anticoagulation of all age groups. This is despite women having a longer life span (and its associated age-related comorbidities), suggesting that oral anticoagulants at an older age is still relevant and physicians should not shy A B Figure 3.…”

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Relationship of Age With Stroke and Death in Anticoagulated Patients With Nonvalvular Atrial Fibrillation

Senoo

Lip

2015

Stroke

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Background and Purpose-The prevalence of atrial fibrillation increases with age, but age-specific data on the incidence of stroke and death in anticoagulated patients with atrial fibrillation are more limited, particularly with regard to comparisons of relative risks of clinical outcomes between the different age strata in relation to quality of anticoagulation control among warfarin users. Methods-We investigated the incidence of adverse outcomes between tertiles of age groups (age, <67 [n=722]

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“…1,6 The mechanisms of increased stroke in females patients with AF have attracted much interest, 7 and quality of anticoagulation control, hormones, and renal dysfunction have all been proposed.…”

Section: Lip Et Al Females Sex and Apixaban 2129mentioning

confidence: 99%

Modification of Outcomes With Aspirin or Apixaban in Relation to Female and Male Sex in Patients With Atrial Fibrillation

Lip

Eikelboom

Yusuf

et al. 2014

Stroke

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The rationale, design, definitions of outcomes, and main results of the AVERROES trial (ClinicalTrials.gov No. NCT00496769) have been published.2 In summary, this was a randomized, multicenter, doubleblinded, parallel-group trial which compared apixaban (at a dose of 5 mg twice daily, with a dose adjustment to 2.5 mg BID for selected patients) with aspirin (81-324 mg per day) for the prevention of Background and Purpose-The main objective of the present analysis was to assess the effect of treatment with aspirin compared with apixaban on ischemic stroke and major bleeding in women compared with men. Female patients with atrial fibrillation are at increased stroke risk compared with male patients, and the underlying reasons for higher risk are uncertain. Methods-Ancillary analysis of the Apixaban Versus Acetylsalicylic Acid [ASA] to Prevent Stroke in Atrial FibrillationPatients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment (AVERROES) trial, comparing aspirin and apixaban, focused on sex differences. Mean follow-up was 1.1 years. Results-Women compared with men tended to be older (aspirin, 71.8 versus 68.8 years; apixaban, 71.4 versus 68.6 years), with a higher proportion of those aged ≥75 years. Also, women had less peripheral artery disease (aspirin, 2.4% versus 3.7%; apixaban, 1.4% versus 3.0%), more heart failure, and higher mean CHADS 2 (congestive heart failure, hypertension, age of 75 years or older, diabetes [1 point each], stroke or transient ischemic attack [2 points]) scores (aspirin, 2.2 versus 2.0; apixaban, 2.1 versus 2.0). Women compared with men had higher ischemic stroke rates (aspirin, 3.99% versus 2.28%; apixaban, 1.55% versus 0.82%) but similar bleeding rates (aspirin, 1.29% versus 1.22%; apixaban, 1.15% versus 1.36%). The relative effect of apixaban compared with aspirin was similar in men and women for both ischemic stroke (women, 3.99% versus 1.55%; hazard ratio, 0.39; 95% confidence interval, 0.23-0.64; men, 2.28% versus 0.82%; hazard ratio, 0.36; 95% confidence interval, 0.19-0.63; P int =0.84) and major bleeding (women, 1.29% versus 1.15%; hazard ratio, 1.15; 95% confidence interval, 0.59-2.23; men, 1.36% versus 1.22%; hazard ratio, 1.13; 95% confidence interval, 0.64-2.02; P int =0.96). Conclusions-Female patients with atrial fibrillation had higher ischemic stroke rates compared with male patients, but the relative effects of apixaban compared with aspirin on both ischemic stroke and bleeding were similar in men and women. (Stroke. 2014;45:2127-2130.)

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Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor (SPORTIF) trials

Abstract: When compared with men with AF, women in these studies were older and had more stroke risk factors. Women were more prone to anticoagulant-related bleeding; the higher rate of thrombo-embolism among women was related to more frequent interruption of anticoagulant therapy.

Cited by 91 publications

References 23 publications

Efficacy and Safety of Rivaroxaban Compared With Warfarin Among Elderly Patients With Nonvalvular Atrial Fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)

Efficacy and Safety of Rivaroxaban Compared With Warfarin Among Elderly Patients With Nonvalvular Atrial Fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)

Relationship of Age With Stroke and Death in Anticoagulated Patients With Nonvalvular Atrial Fibrillation

Modification of Outcomes With Aspirin or Apixaban in Relation to Female and Male Sex in Patients With Atrial Fibrillation

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