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Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

ABSTRACT: Patients with atrial fibrillation (AF) and hypertension are at high risk for stroke. Previous studies have shown elevated risk of stroke in patients with AF who have a history of hypertension (regardless of blood pressure [BP] control) and in patients with elevated BP. We assessed the association of hypertension and BP control on clinical outcomes.In ARISTOTLE (n=18 201), BP was evaluated as history of hypertension requiring treatment and elevated BP (systolic ≥140 and/or diastolic ≥90 mm Hg) at study entry and any point during the trial. Hazard ratios (HRs) were derived from Cox proportional hazards models including BP as a time-dependent covariate. A total of 15 916 (87.5%) patients had a history of hypertension requiring treatment. In patients with elevated BP measurement at any point during the trial, the rate of stroke or systemic embolism was significantly higher (HR, 1.53; 95% confidence interval [CI], 1.25-1.86), as was hemorrhagic stroke (HR 1.85; 95% CI, 1.26-2.72) and ischemic stroke (HR, 1.50; 95% CI, 1.18-1.90). Rates of major bleeding were lower in patients with a history of hypertension (HR, 0.80; 95% CI, 0.66-0.98) and nonsignificantly lower in patients with elevated BP at study entry (HR, 0.89; 95% CI, 0.77-1.03). The benefit of apixaban versus warfarin on preventing stroke or systemic embolism was consistent among patients with and without a history of hypertension (P interaction=0.27), BP control at baseline (P interaction=0.43), and BP control during the trial (P interaction=0.97).High BP measurement at any point during the trial was independently associated with a substantially higher risk of stroke or systemic embolism. These results strongly support efforts to treat elevated BP as an important strategy to optimally lower risk of stroke in patients with AF.URL: https://ClinicalTrials.gov/. Unique identifier: NCT00412984.

SUBMITTER: Rao MP

PROVIDER: S-EPMC4845276 | biostudies-other | 2015 Dec

REPOSITORIES: biostudies-other

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Project description:ObjectivesWe identified factors associated with thromboembolic and bleeding events in two contemporary cohorts of anticoagulated patients with atrial fibrillation (AF), treated with either vitamin K antagonists (VKA) or non-VKA oral anticoagulants (NOACs).DesignProspective, multicentre observational study.Setting461 centres in seven European countries.Participants5310 patients receiving a VKA (PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF), derivation cohort) and 3156 patients receiving a NOAC (PREFER in AF Prolongation, validation cohort) for stroke prevention in AF.Outcome measuresRisk factors for thromboembolic events (ischaemic stroke, systemic embolism) and major bleeding (gastrointestinal bleeding, intracerebral haemorrhage and other life-threatening bleeding).ResultsThe mean age of patients enrolled in the PREFER in AF registry was 72±10 years, 40% were female and the mean CHA2DS2-VASc Score was 3.5±1.7. The incidence of thromboembolic and major bleeding events was 2.34% (95% CI 1.93% to 2.74%) and 2.84% (95% CI 2.41% to 3.33%) after 1-year of follow-up, respectively.Abnormal liver function, prior stroke or transient ischaemic attack, labile international normalised ratio (INR), concomitant therapy with antiplatelet or non-steroidal anti-inflammatory drugs, heart failure and older age (≥75 years) were independently associated with both thromboembolic and major bleeding events.With the exception of unstable INR values, these risk factors were validated in patients treated with NOACs (PREFER in AF Prolongation Study, 72±9 years, 40% female, CHA2DS2-VASc 3.3±1.6). For each single point decrease on a modifiable bleeding risk scale we observed a 30% lower risk for major bleeding events (OR 0.70, 95% CI 0.64 to 0.76, p<0.01) and a 28% lower rate of thromboembolic events (OR 0.72, 95% CI 0.66 to 0.82, p<0.01).ConclusionAttending to modifiable risk factors is an important treatment target in anticoagulated AF patients to reduce thromboembolic and bleeding events. Initiation of anticoagulation in those at risk of stroke should not be prevented by elevated bleeding risk scores.

Project description:BackgroundNonvalvular atrial fibrillation (NVAF) is an independent risk factor for ischemic stroke and is common in chronic kidney disease (CKD) and dialysis patients. The use of oral anticoagulation to prevent stroke and systemic embolism in the setting of kidney disease is controversial. Novel alternatives to vitamin K antagonists include left atrial appendage occlusion devices (LAAOD) and apixaban.ObjectiveWe sought to elicit Canadian nephrologist views regarding stroke and systemic embolism prevention therapies in CKD and dialysis patients with NVAF.DesignSurvey.SettingOnline via https://www.surveymonkey.com.ParticipantsCanadian Society of Nephrology members actively treating adult dialysis patients with NVAF.MeasurementsManagement questions were asked with response options consisting of a Likert scale ranging from 1 to 8 (with 1 being definitely would not and 8 being definitely would).MethodsWe randomly allocated each respondent to 2 of 4 cases that varied by stroke and bleeding risks (using varying CHADS2 and HASBLED scores, respectively).ResultsThere were 91 responses (36.3% response rate) from mostly university (83.5%) and also community with university affiliation (12.1%) and community (4.4%) nephrologists. Warfarin was more likely to be recommended in individuals at high stroke risk and low bleeding risk (mean = 5.47, 95% confidence interval = 4.87-6.07) and less likely to be recommended in individuals at moderate stroke risk and high bleeding risk (mean = 2.89, 95% confidence interval = 2.37-3.41). The likelihood of recommending LAAOD did not vary by stroke or bleeding risks (means ranging from 3.92-4.90). Apixaban was not likely to be recommended in any case (means ranging from 2.60-3.50). However, nephrologists felt there was equipoise regarding anticoagulation strategies allowing participation in appropriate randomized controlled trials (RCTs).LimitationsThe survey only involved nephrologists and only 4 cases with dichotomized risk categories were presented instead of complete range of stroke and bleeding risk combinations. As with any survey, there was the potential for responder bias and treatment decisions are not anchored directly to patient management.ConclusionsNephrologists caring for patients with kidney disease appear willing to include patients in clinical trials examining alternatives to warfarin for stroke and systemic embolism prevention for NVAF in the setting of kidney disease.

Project description:Background:The comparative safety and effectiveness of treatments to prevent thromboembolic complications in atrial fibrillation (AF) remain uncertain. Purpose:To compare the effectiveness of medical and procedural therapies in preventing thromboembolic events and bleeding complications in adults with nonvalvular AF. Data Sources:English-language studies in several databases from 1 January 2000 to 14 February 2018. Study Selection:Two reviewers independently screened citations to identify comparative studies of treatments to prevent stroke in adults with nonvalvular AF who reported thromboembolic or bleeding complications. Data Extraction:Two reviewers independently abstracted data, assessed study quality and applicability, and rated strength of evidence. Data Synthesis:Data from 220 articles were included. Dabigatran and apixaban were superior and rivaroxaban and edoxaban were similar to warfarin in preventing stroke or systemic embolism. Apixaban and edoxaban were superior and rivaroxaban and dabigatran were similar to warfarin in reducing the risk for major bleeding. Treatment effects with dabigatran were similar in patients with renal dysfunction (interaction P > 0.05), and patients younger than 75 years had lower bleeding rates with dabigatran (interaction P < 0.001). The benefit of treatment with apixaban was consistent in many subgroups, including those with renal impairment, diabetes, and prior stroke (interaction P > 0.05 for all). The greatest bleeding risk reduction was observed in patients with a glomerular filtration rate less than 50 mL/min/1.73 m2 (P = 0.003). Similar treatment effects were observed for rivaroxaban and edoxaban in patients with prior stroke, diabetes, or heart failure (interaction P > 0.05 for all). Limitation:Heterogeneous study populations, interventions, and outcomes. Conclusion:The available direct-acting oral anticoagulants (DOACs) are at least as effective and safe as warfarin for patients with nonvalvular AF. The DOACs had similar benefits across several patient subgroups and seemed safe and efficacious for a wide range of patients with nonvalvular AF. Primary Funding Source:Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42017069999).

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Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

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