Dabigatran for stroke prevention in atrial fibrillation

2012 ◽  
Vol 32 (03) ◽  
pp. 216-220 ◽  
Author(s):  
H.-C. Diener ◽  
S. H. Hohnloser
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Prevention ◽  
Relative Risk Reduction ◽  
Haemorrhagic Stroke ◽  
Similar Rate ◽  
Thrombin Inhibitor ◽  
Secondary Stroke Prevention ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Low Incidence

SummaryDabigatran is a novel direct thrombin inhibitor that has recently been approved for primary and secondary stroke prevention and prevention of systemic embolism in patients with atrial fibrillation. In the pivotal RE-LY study, dabigatran 110 mg BID was demonstrated to be associated with a stroke rate similar to that observed with warfarin (INR target 2.0 to 3.0), but with a lower rate of major haemorrhage. Dabigatran administered at a dose of 150 mg BID was significantly more effective in stroke prevention than warfarin and showed a similar rate of major hemorrhages. Of note, both dosages resulted in an approximately 60–70% relative risk reduction of haemorrhagic stroke. The dosage of 110 mg BID should be preferably used in patients aged 75–80 years or older as the rate of extracranial bleeding events tends to increase with dabigatran 150 mg BID above this age limit. In RE-LY, myocardial infarcts occurred at a very low incidence. There were numerically more myocardial infarcts in dabigatran-treated patients than in warfarin patients; however, other myocardial ischaemic events were similar in the three treatment arms.

Advances in Atrial Fibrillation-related Stroke Prevention

2015 ◽  
Vol 9 (2) ◽  
pp. 122
Author(s):  
Pierre Amarenco ◽  
Werner Hacke ◽  
Bo Norrving ◽  
Natalia Rost ◽  
◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Stroke Prevention ◽  
Stroke Risk ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
Haemorrhagic Stroke ◽  
Bleeding Events ◽  
Patients At Risk

In patients with atrial fibrillation (AF) the risk of stroke is substantially increased, especially in those who are elderly (over 75 years) or have risk factors such as previous stroke, heart failure or hypertension. Stroke outcomes are also generally much worse in those with AF. Current guidelines indicate that any patient with AF and risk factors for stroke should receive anticoagulant therapy to limit their stroke risk. Despite these established recommendations, only 50 % of patients at risk receive anticoagulation with a vitamin K antagonist (VKA) and only 50 % of those are within the therapeutic range, indicating lack of adherence to the guidelines. Withholding anticoagulant therapy is mainly left to an individual physician’s choice, as shown in the ongoing GARFIELD registry of AF stroke prevention practice. Many physicians fear the risk of intracranial haemorrhage (ICH) for which outcomes remain poor. Recent clinical studies have shown that the non-VKA oral anticoagulants (NOACs) (apixaban, rivaroxaban, dabigatran and edoxaban) significantly reduce the risk of ICH and other bleeding events, while having non-inferior stroke prevention to warfarin. Use of these drugs, limiting exposure to aspirin and alcohol and controlling blood pressure have been shown to minimise ICH risk in large clinical trials and meta-analyses. Recent data from the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE AF)-TIMI 48 study showed that the factor Xa inhibitor edoxaban was non-inferior to well-managed warfarin for reducing all stroke risk, and significantly reduced haemorrhagic stroke, major bleeding, ICH and death. These findings further support the case for using NOAC therapy for stroke prevention in patients with AF and risk factors for stroke.

Effectiveness and safety of edoxaban in patients with atrial fibrillation: data from the Danish Nationwide Cohort

2019 ◽  
Author(s):  
Peter Brønnum Nielsen ◽  
Torben Bjerregaard Larsen ◽  
Flemming Skjøth ◽  
Mette Søgaard ◽  
Gregory Y H Lip
Keyword(s):  
Atrial Fibrillation ◽  
Stroke Prevention ◽  
Treatment Options ◽  
Clinical Effectiveness ◽  
Systemic Embolism ◽  
Antithrombotic Treatment ◽  
Bleeding Events ◽  
Once Daily ◽  
Randomized Controlled

Abstract Aims Edoxaban treatment for stroke prevention in atrial fibrillation (AF) has mainly been investigated in randomized controlled trials, and data reflecting clinical practice are limited. We ascertained the clinical effectiveness and safety of edoxaban 30 and 60 mg once daily among Danish patients with AF. Methods and results This was an observational study based on Danish nationwide registries collecting information for administrative purposes. From June 2016 through November 2018, we identified 3405 patients initiating edoxaban. After exclusions, 2285 AF patients were followed for the effectiveness outcome of thromboembolism (ischaemic stroke and/or systemic embolism) and bleeding outcomes (composite of major bleeding, gastrointestinal bleeding, and intracranial haemorrhage), as well as bleeding requiring hospitalization. Population mean age was 75 years and 43% were female; 643 patients received the 30 mg edoxaban dosage regimen and 1642 initiated 60 mg edoxaban. During follow-up, we observed 41 thromboembolic events and 89 bleeding events of which 40 events required hospitalization. Among patients with 30 mg edoxaban, the rate (per 100 person-years) of thromboembolism was 2.07 vs. 1.62 for 60 mg edoxaban. Rates of bleeding were similar for the two dosages at ∼3.85. Bleeding requiring hospitalization occurred at a rate of 1.74 for 30 mg edoxaban and 1.69 with 60 mg edoxaban. Conclusion In this nationwide cohort of Caucasian AF patients treated with edoxaban for stroke prevention, the clinical effectiveness and safety were in line with data from the ENGAGE AF-TIMI 48 trial. Studies investigating comparative effectiveness and safety for edoxaban in comparison with other choices of antithrombotic treatment options are needed.

scholarly journals Impact of oral anticoagulation in patients with atrial fibrillation at very low thromboembolic risk

Heart ◽  
2019 ◽  
Vol 106 (11) ◽  
pp. 845-851
Author(s):  
Frederik Hendrik Verbrugge ◽  
Anne-Céline Martin ◽  
Deborah Siegal ◽  
Karen Pieper ◽  
Laura Illingworth ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Haemorrhagic Stroke ◽  
Inverse Association ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Thromboembolic Risk ◽  
All Cause Mortality

ObjectiveTo investigate reasons for and impact of oral anticoagulation (OAC) in patients with atrial fibrillation (AF) at very low thromboembolic risk.MethodsIndividuals with CHA2DS2-VASc score 0 (men) or 1 (women) from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) were studied. Baseline characteristics according to OAC use were evaluated by logistic regression analysis. Non-haemorrhagic stroke or systemic embolism, major bleeding, cardiovascular and all-cause mortality were compared.ResultsFrom 2224 low CHA2DS2-VASc patients in GARFIELD-AF, 44% received OAC. In an adjusted model, increasing age up to 65 years (OR (95% CI)=1.31 (1.19 to 1.44)) and persistent AF (OR (95% CI)=3.25 (2.44 to 4.34)) or permanent AF (OR (95% CI)=2.29 (1.59 to 3.30)) versus paroxysmal/unclassified AF were associated with OAC use. Concomitant antiplatelet therapy (OR (95% CI)=0.21 (0.17 to 0.27)) was inversely associated. Crude incidence rates per 100 person-years over 2 years in patients on OAC versus not on OAC were 0.32 (95% CI 0.14 to 0.71) vs 0.30 (95% CI 0.14 to 0.63) for non-haemorrhagic stroke or systemic embolism, 0.21 (95% CI 0.08 to 0.57) vs 0.17 (95% CI 0.06 to 0.46) for major bleeding, 0.26 (95% CI 0.11 to 0.64) vs 0.26 (95% CI 0.12 to 0.57) for cardiovascular mortality and 0.74 (95% CI 0.44 to 1.25) vs 0.99 (95% CI 0.66 to 1.49) for all-cause mortality.ConclusionsIn contrast to guideline recommendations, almost half of real-world patients with AF at a very low thromboembolic risk according to the CHA2DS2-VASc score receive OAC. Persistent or permanent AF and increasing age up to 65 years are associated with OAC use, while concomitant antiplatelet therapy shows an inverse association. Regardless whether patients received OAC therapy, few thromboembolic and bleeding events occur, highlighting the low risk of this population.

scholarly journals Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study

2020 ◽  
Author(s):  
Joris R de Groot ◽  
Thomas W Weiss ◽  
Peter Kelly ◽  
Pedro Monteiro ◽  
Jean Claude Deharo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Stroke Prevention ◽  
Clinical Care ◽  
Oral Anticoagulants ◽  
Routine Care ◽  
European Medicines Agency ◽  
Systemic Embolism ◽  
Bleeding Events

Abstract Aims Non-vitamin K oral anticoagulants are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report 1-year outcomes in patients with AF treated with edoxaban in routine care. Methods and results ETNA-AF-Europe is a prospective, multicentre, post-authorization, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban’s post-approval safety plan. Altogether 13 092 patients in 852 sites completed the 1-year follow-up [mean age: 73.6 ± 9.5 years; 57% male, mean follow-up: 352 ± 49 days (median: 366 days)]. Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualized event rate: 0.82%/year), and major bleeding events were reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low [30 patients (0.24%/year)]. Death occurred in 442 patients (3.50%/year); cardiovascular (CV) death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and CV mortality were higher in patients receiving edoxaban 30 mg vs. 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg vs. 60 mg. Conclusion The rates of stroke, systemic embolism, and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.

scholarly journals Non-vitamin K oral anticoagulants for secondary stroke prevention in patients with atrial fibrillation

2020 ◽  
Vol 22 (Supplement_I) ◽  
pp. I13-I21
Author(s):  
Hans-Christoph Diener ◽  
Graeme J Hankey ◽  
J Donald Easton ◽  
Gregory Y H Lip ◽  
Robert G Hart ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Vitamin K ◽  
Major Bleeding ◽  
Stroke Prevention ◽  
Oral Anticoagulants ◽  
Haemorrhagic Stroke ◽  
Recurrent Bleeding ◽  
Secondary Stroke Prevention ◽  
Significant Difference

Abstract The aims of this article are to review the evidence regarding the use of non-vitamin K oral anticoagulants (NOACs) for secondary stroke prevention as compared to vitamin K antagonists in patients with atrial fibrillation (AF) and in patients with embolic strokes of uncertain source (ESUS), and when to initiate or resume anticoagulation after an ischaemic stroke or intracranial haemorrhage. Four large trials compared NOACs with warfarin in patients with AF. In our meta-analyses, the rate of all stroke or systemic embolism (SE) was 4.94% with NOACs vs. 5.73% with warfarin. Among the patients with AF and previous transient ischaemic attack or ischaemic stroke, the rate of haemorrhagic stroke was halved with a NOAC vs. warfarin, and the rate of major bleeding was 5.7% with a NOAC vs. 6.4% with warfarin. There was no significant difference in mortality. In a trial comparing apixaban with aspirin in patients with AF, the rate of stroke or SE was 2.4% at 1 year with apixaban vs. 9.2% at 1 year with aspirin and the rates of major bleeding were 4.1% with apixaban vs. 2.9% with aspirin. Data from registries confirmed the results from the randomized trials. Initiation or resumption of anticoagulation after ischaemic stroke or cerebral haemorrhage depends on the size and severity of stroke and the risk of recurrent bleeding. Two large trials tested the hypothesis that NOACs are more effective than 100 mg aspirin in patients with ESUS. Neither trial showed a significant benefit of the NOAC over aspirin. In the meta-analysis, the rate all stroke or SE was 4.94% with NOACs vs. 5.73% with warfarin and the rate of haemorrhagic stroke was halved with a NOAC. The four NOACs had broadly similar efficacy for the major outcomes in secondary stroke prevention.

EXPRESS: Comparative effectiveness and safety of edoxaban vs warfarin in patients with atrial fibrillation: A nationwide cohort study

2021 ◽  
pp. 174749302110294
Author(s):  
Peter Nielsen ◽  
Mette Soegaard ◽  
Martin Jensen ◽  
Anne G Ording ◽  
Gregory Lip
Keyword(s):  
Atrial Fibrillation ◽  
Confidence Intervals ◽  
Stroke Prevention ◽  
Clinical Care ◽  
Bleeding Events ◽  
Inverse Probability ◽  
Standard Clinical Practice ◽  
Hazard Ratios ◽  
All Cause Mortality ◽  
Event Rates

Background and purpose: The effectiveness and safety of edoxaban 60 mg and 30 mg for stroke prevention compared with warfarin in patients with atrial fibrillation (AF) has not been well-described in a nationwide cohort of Caucasian patients treated in standard clinical practice. Methods: We used Danish nationwide registries to identify patients with AF during June 2016 and November 2018 who were treated with edoxaban or warfarin and computed rates per 100 person-years of thromboembolic, all-cause mortality, and bleeding events using an inverse probability of treatment weighting approach to account for baseline confounding. We used weighted pooled logistic regression to compute hazard ratios (HRs) with 95% confidence intervals (CIs) comparing events between edoxaban 60 mg and warfarin users; edoxaban 30 mg was not included in formal comparisons. Results: We identified 6451 AF patients, mean age was 72 years and 40% were females. A total of 1772 patients were treated with edoxaban 60 mg, 537 with edoxaban 30 mg, and 4142 with warfarin. The median CHA2DS2-VASc score was similar between warfarin and edoxaban 60 mg with a score of 3 (interquartile range [IQR] 2-4). In the inverse probability of treatment-weighted pseudo-population, the thromboembolic event rate for edoxaban 60 mg was 0.95 and 1.0 for warfarin, corresponding weighted HR of 1.00 (95% confidence intervals [CI] 0.59, 1.71). Edoxaban 60 mg users were associated with lower rates of all-cause mortality (3.93) compared to warfarin (6.04), with a HR of 0.64 (95% CI 0.47 to 0.88). The event rates for bleeding were 3.36 and 3.14, respectively; HR 1.09 (95% CI 0.77, 1.57) Conclusion: Edoxaban 60 mg is a safe and effective treatment compared with warfarin for stroke prevention in routine clinical care for white European patients with AF, with non-significantly different risks for stroke and clinically relevant bleeding, but lower all-cause mortality. 

scholarly journals Anticoagulation Challenges in Hematogeriatrics: Effectiveness and Safety of Direct Oral Anticoagulants Vs Vitamin k Antagonist in Elderly with Atrial Fibrillation

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1162-1162
Author(s):  
Desirée Campoy ◽  
Gonzalo Artaza ◽  
César A Velasquez ◽  
Tania Canals ◽  
Erik A Johansson ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Vitamin K ◽  
Major Bleeding ◽  
Frail Elderly ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Bleeding Events

BACKGROUND Direct oral anticoagulants (DOAC) are increasingly used in patients with Non Valvular Atrial Fibrillation (NVAF) for stroke prevention. However, Follow-Up (FU) and dosing these agents in the elderly can be challenging due to different factors, such as chronic kidney disease, frailty, falls, multifactorial anemia and concomitant polypharmacy. These factors in elderly patients predisposes to both thromboembolic and bleeding events once atrial fibrillation occurs. Therefore, balancing risks and benefits of antithrombotic strategies in older populations is crucial. Despite recent increases in DOAC use in NVAF, there are still limited data regarding DOACs effectiveness and safety in frail elderly patients. AIM To assess the effectiveness and safety according to DOAC or Vitamin K Antagonist (VKA) in a cohort of elderly patients with NVAF. METHODS From April 2016 to April 2019, we consecutively included NVAF elderly patients (≥80 years-old) treated with DOAC or VKA in a prospective multicenter registry. Demographic, laboratory, frailty risk stratification and antithrombotic therapy data were collected. Patients had a minimum FU of 6 months. VKA patients had a standard FU through digital international normalized ratio (INR) control and the efficacy of therapy was determined by the time in therapeutic range (TTR) values from the preceding 6 months of treatment using Rosendaal's method. FU in DOAC patients was performed through structured and integral assessment following the Tromboc@t Working Group recommendations for management in patients receiving DOAC (Olivera et al, Med Clin 2018). Key practical management aspects are listed in the flow chart (Figure 1). Clinical Frailty Scale (CFS score) was assigned to each patient at the beginning and during the FU; patients were classified into three categories: non-frail (CFS 1-4), mild-to-moderately frail (CFS 5-6), and severely frail (CFS 7-9). RESULTS From a total of 1040 NVAF patients, 690 (63.5%) were treated with DOAC (61 dabigatran, 95 rivaroxaban, 254 edoxaban and 280 apixaban) and 350 with VKA. In the VKA group, the mean TTR was 52.8%. Demographic characteristics and CFS score are summarized in table 1. Kaplan-Meier analysis (median FU: 16.5 months) showed a significantly high incidence of stroke/systemic embolism among VKA patients vs DOAC patients (4.2 vs 0.5 events per 100 patient-years, p<0.001). Major bleeding in the DOAC group was significantly infrequent compared with VKA group (2.2 vs 8.9 events, p=0.001). In the DOAC group, 90% (n=20/22) of the major bleedings were gastrointestinal [16 rivaroxaban and 4 edoxaban]. However, in the VKA group 64% (n = 20/31) were gastrointestinal, 25.8% (n= 8/31) intracranial and 9.7% (n = 3/31) urogenital bleedings. We identified 365 very elderly patients (aged ≥ 90 years) of which 270 (39.1%) were DOAC patients and 95 (27.1%) VKA patients. In this subgroup of patients, after a multivariate regression analysis, the stroke/systemic embolism incidence was similar in both treatment groups regardless of the age, but major bleeding decreased significantly in DOAC group (adjusted HR 0.247, 95% CI 0.091-0.664). CONCLUSIONS Our data indicate that DOACs can be a good therapeutic option for stroke/systemic embolism prevention in frail elderly patients, showing low rates of stroke as well as bleeding events when a structured and integral FU is applied to anticoagulated patients. Further investigations are necessary to analyze the impact in the quality of life and net clinical benefit of anticoagulant therapy when a FU program is applied in elderly patients. Disclosures Sierra: Novartis: Honoraria, Research Funding, Speakers Bureau; Astellas: Honoraria; Pfizer: Honoraria; Daiichi-Sankyo: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Roche: Honoraria; Jazz Pharmaceuticals: Honoraria.

Stroke prevention in atrial fibrillation

ESC CardioMed ◽  
2018 ◽  
pp. 2185-2195
Author(s):  
Michael D. Ezekowitz ◽  
Amanulla N. Khaji
Keyword(s):  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Stroke Prevention ◽  
Left Atrial ◽  
Haemorrhagic Stroke ◽  
Atrial Appendage ◽  
Ageing Population ◽  
The Novel ◽  
Left Atrial Appendage Occlusion ◽  
Novel Agent

Atrial fibrillation (AF) is a modern epidemic affecting the rapidly growing ageing population. Stroke related to AF can be devastating. The use of anticoagulation and more recently left atrial appendage occlusion devices makes stroke related to AF a potentially preventable event. Warfarin reduces stroke in completed trials against placebo by about 80%. Warfarin and apixaban, the only novel agent to be tested against aspirin, beats aspirin by about 50% and dual antiplatelet therapy by a similar margin. The novel agents dabigatran, rivaroxaban, apixaban, and edoxaban reduce strokes by 9–30% compared to warfarin. Approximately 80% of dabigatran is excreted by the kidneys (RE-LY trial), and dabigatran reduced the risk of stroke or systemic embolism compared to warfarin by 34% (p <0.001, superiority) for a 150 mg dose, and by 9% (p <0.001, non-inferiority) for a 110 mg dose. The risk of haemorrhagic stroke, compared to warfarin, was significantly lower with a 150 mg dose (74%) as well as with a 110 mg dose (69%). Gastrointestinal bleeding occurred more frequently in subjects who received 150 mg twice daily (1.51%/year) compared to 110 mg twice daily (1.12%/year) and warfarin (1.02%/year). Dyspepsia occurs in 5–10% of patents leading to permanent discontinuation in 2%.

6072Risk of stroke in hypertensive patients with atrial fibrillation treated with oral anticoagulants

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R E Harskamp ◽  
W A M Lucassen ◽  
R D Lopes ◽  
H C Van Weert
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Haemorrhagic Stroke ◽  
Uncontrolled Hypertension ◽  
P Value ◽  
Systemic Embolism ◽  
History Of

Abstract Background Hypertension is common in patients with atrial fibrillation (AF) and carries an additional risk for complications, most notably stroke and bleeding. We assessed the history of hypertension, level of blood pressure control, and an interaction with the choice of oral anticoagulants on clinical outcomes. Purpose To gain insights into the risks of hypertension in the setting of AF and explore possible interactions with the safety and efficacy of non-vitamin K oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs). Methods We performed a systematic review and meta-analysis of studies that randomised patients to NOACs or VKAs and reported outcomes stratified by presence of hypertension. Collected outcomes included: ischaemic stroke or systemic embolism (SE), death from any cause, hemorrhagic stroke, major bleeding, and intracranial hemorrhage. Log adjusted hazard ratios (HR) and corresponding standard error were calculated, and HRs were compared using Mantel-Haenszel random effects. Quality of the evidence was assessed with Cochrane risk of bias tool. Results Five high-quality studies were eligible, including 71,602 participants who received NOACs (apixaban, dabigatran, edoxaban, rivaroxaban) or VKAs, with median follow-up of 1.8–2.8 years. 89.2% of participants had a history of hypertension. Compared with patients without hypertension, those with controlled and uncontrolled hypertension had higher risk for stroke/SE (HR: 1.21 [1.04–1.41] and HR: 1.50 [1.12–2.01], respectively) and haemorrhagic stroke (HR: 1.78 [1.06, 3.00] and HR: 1.66 [0.99–4.01], respectively). On a continuous scale, the risk of stroke increased 7% per 10mmHg increase in systolic blood pressure. As shown in the Table, no interactions were found between hypertension status and the efficacy or safety of NOACs versus VKAs. Table 1. Interaction of presence of hypertension on the comparative efficacy and safety of NOAC versus VKA Hypertension (n=63,869) No hypertension (n=7,733) P-value (int) Adjusted HR, 95% CI Adjusted HR, 95% CI Stroke or systemic embolism 080, 0.72–0.89 0.79, 0.53–1.19 0.98 Haemorrhagic stroke 0.55, 0.41–0.74 0.24, 0.04–1.37 0.36 Death from any cause 0.91, 0.84–0.98 0.89, 0.76–1.04 0.82 Major bleeding 0.90, 0.76–1.07 0.84, 0.69–1.01 0.57 Intracranial haemorrhage 0.41, 0.24-.068 0.48, 0.14–1.69 0.81 Major or clinically relevant non-major bleed 0.90, 0.68–1.18 0.91, 0.55–1.53 0.96 Conclusions Adequate blood pressure management is vital to optimally reduce the risk of stroke in patients with atrial fibrillation. The benefits of NOACs over VKAs, also apply to patients with elevated blood pressure.

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