scholarly journals Early Recurrence and Major Bleeding in Patients With Acute Ischemic Stroke and Atrial Fibrillation Treated With Non–Vitamin‐K Oral Anticoagulants (RAF‐NOACs) Study

Author(s):  
Maurizio Paciaroni ◽  
Giancarlo Agnelli ◽  
Nicola Falocci ◽  
Georgios Tsivgoulis ◽  
Kostantinos Vadikolias ◽  
...  
Stroke ◽  
2020 ◽  
Vol 51 (8) ◽  
pp. 2347-2354
Author(s):  
Michela Giustozzi ◽  
Monica Acciarresi ◽  
Giancarlo Agnelli ◽  
Valeria Caso ◽  
Fabio Bandini ◽  
...  

Background and Purpose: The optimal timing for starting oral anticoagulant after an ischemic stroke related to atrial fibrillation remains a challenge, mainly in patients treated with systemic thrombolysis or mechanical thrombectomy. We aimed at assessing the incidence of early recurrence and major bleeding in patients with acute ischemic stroke and atrial fibrillation treated with thrombolytic therapy and/or thrombectomy, who then received oral anticoagulants for secondary prevention. Methods: We combined the dataset of the RAF and the RAF-NOACs (Early Recurrence and Major Bleeding in Patients With Acute Ischemic Stroke and Atrial Fibrillation Treated With Non–Vitamin K Oral Anticoagulants) studies, which were prospective observational studies carried out from January 2012 to March 2014 and April 2014 to June 2016, respectively. We included consecutive patients with acute ischemic stroke and atrial fibrillation treated with either vitamin K antagonists or nonvitamin K oral anticoagulants. Primary outcome was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding within 90 days from the inclusion. Treated-patients were propensity matched to untreated-patients in a 1:1 ratio after stratification by baseline clinical features. Results: A total of 2159 patients were included, 564 (26%) patients received acute reperfusion therapies. After the index event, 505 (90%) patients treated with acute reperfusion therapies and 1287 of 1595 (81%) patients untreated started oral anticoagulation. Timing of starting oral anticoagulant was similar in reperfusion-treated and untreated patients (median 7.5 versus 7.0 days, respectively). At 90 days, the primary study outcome occurred in 37 (7%) patients treated with reperfusion and in 146 (9%) untreated patients (odds ratio, 0.74 [95% CI, 0.50–1.07]). After propensity score matching, risk of primary outcome was comparable between the 2 groups (odds ratio, 1.06 [95% CI, 0.53–2.02]). Conclusions: Acute reperfusion treatment did not influence the risk of early recurrence and major bleeding in patients with atrial fibrillation–related acute ischemic stroke, who started on oral anticoagulant.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Giustozzi

Abstract Background The optimal timing for starting anticoagulation after an acute ischemic stroke related to non-valvular atrial fibrillation (AF) remains a challenge, especially in patients treated with systemic thrombolysis or mechanical thrombectomy. Purpose We aimed to assess the rates of early recurrence and major bleeding in patients with acute ischemic stroke and AF treated with thrombolytic therapy and/or thrombectomy who received oral anticoagulants for secondary prevention. Methods We combined the dataset of the RAF and the RAF-NOACs studies, which were prospective observational studies carried out from January 2012 to March 2014 and April 2014 to June 2016, respectively. We included consecutive patients with acute ischemic stroke and AF treated with either vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Primary outcome was the composite of stroke, transient ischemic attack, symptomatic systemic embolism, symptomatic cerebral bleeding, and major extracerebral bleeding within 90 days from the inclusion. Results A total of 2,159 patients were included in the RAF and RAF-NOACs trials, of which 564 patients (26%) were treated with urgent reperfusion therapy. After acute stroke, 505 (90%) patients treated with reperfusion and 1,287 out of the 1,595 (81%) patients not treated with reperfusion started oral anticoagulation. Timing of starting oral anticoagulation was similar in reperfusion-treated and untreated patients (13.5±23.3 vs 12.3±18.3 days, respectively, p=0.287). At 90 days, the composite rate of recurrence and major bleeding occurred in 37 (7%) of patients treated with reperfusion treatment and in 139 (9%) of untreated patients (p=0.127). Twenty-four (4%) reperfusion-treated patients and 82 (5%) untreated patients had early recurrence while major bleeding occurred in 13 (2%) treated and in 64 (4%) untreated patients, respectively. Seven patients in the untreated group experienced both an ischemic and hemorrhagic event. Figure 1 shows the risk of early recurrence and major bleeding over time in patients treated and not treated with reperfusion treatments. The use of NOACs was associated with a favorable rate of the primary outcome compared to VKAs (Odd ratio 0.4, 95% Confidence Interval 0.3–0.7). Conclusions Reperfusion treatment did not influence the risk of early recurrence and major bleeding in patients with AF-related acute ischemic stroke who started anticoagulant treatment. Figure 1 Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 8 (10) ◽  
pp. 1624 ◽  
Author(s):  
Moon ◽  
Lee ◽  
Choi ◽  
Lee ◽  
Jung ◽  
...  

Background: There are limited data for non-vitamin K antagonist oral anticoagulants (NOACs) impact on outcomes for patients with atrial fibrillation (AF) and valvular heart diseases (VHDs). Methods: We identified patients with AF and associated Evaluated Heartvalves, Rheumatic or Artificial (EHRA) type 2 VHDs, and who had been naïve from the oral anticoagulants in the Korean National Health Insurance Service database between 2014 and 2016 (warfarin: n = 2671; NOAC: n = 3058). For analyzing the effect of NOAC on primary prevention, we excluded those with a previous history of ischemic stroke, intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding events. To balance covariates, we used the propensity score weighting method. Ischemic stroke, ICH, GI bleeding, major bleeding, all-cause death, and their composite outcome and fatal clinical events were evaluated. Results: During a follow-up with a mean duration of 1.4 years, NOACs were associated with lower risks of ischemic stroke (hazard ratio (HR): 0.71, 95% confidence interval (CI): 0.53–0.96), GI bleeding (HR: 0.50, 95% CI: 0.35–0.72), fatal ICH (HR: 0.28, 95% CI: 0.07–0.83), and major bleeding (HR: 0.61, 95% CI: 0.45–0.80) compared with warfarin. Overall, NOACs were associated with a lower risk of the composite outcome (HR: 0.68, 95% CI: 0.58–0.80). Conclusions: In this nationwide Asian AF population with EHRA type 2 VHDs, NOAC use was associated with lower risks of ischemic stroke, major bleeding, all-cause death, and the composite outcome compared to warfarin use.


Stroke ◽  
2021 ◽  
Author(s):  
Soonil Kwon ◽  
So-Ryoung Lee ◽  
Eue-Keun Choi ◽  
Euijae Lee ◽  
Jin-Hyung Jung ◽  
...  

Background and Purpose: Limited data support the benefits of non–vitamin K oral anticoagulants (NOACs) among atrial fibrillation patients with prior gastrointestinal bleeding (GIB). We aimed to evaluate the effectiveness and safety of NOACs compared with those of warfarin among atrial fibrillation patients with prior GIB. Methods: Oral anticoagulant–naive individuals with atrial fibrillation and prior GIB between January 2010 and April 2018 were identified from the Korean claims database. NOAC users were compared with warfarin users by balancing covariates using the inverse probability of treatment weighting method. The primary outcomes were ischemic stroke, major bleeding, and the composite outcome (combined ischemic stroke and major bleeding). Fatal events from each outcome were evaluated as secondary outcomes. Results: A total of 42 048 patients were included (24 781 in the NOAC group and 17 267 in the warfarin group). The mean time from prior GIB to the initiation of oral anticoagulant was 3.1±2.6 years. After inverse probability of treatment weighting, baseline characteristics were balanced between the two groups (mean age, 72 years; men, 56.8%; and mean CHA 2 DS 2 -VASc score, 3.7). Lower risks of ischemic stroke, major bleeding, and the composite outcome were associated with NOAC use than with warfarin use (weighted hazard ratio, 0.608 [95% CI, 0.543–0.680]; hazard ratio, 0.731 [95% CI, 0.642–0.832]; and hazard ratio, 0.661 [95% CI, 0.606–0.721], respectively). For all secondary outcomes, NOACs showed greater risk reductions compared with warfarin. Conclusions: NOACs were associated with lower risks of ischemic stroke and major bleeding than warfarin among atrial fibrillation patients with prior GIB.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P.S Yang ◽  
M Shim ◽  
S.H Kang ◽  
S.H Kim ◽  
W.J Kim ◽  
...  

Abstract Background and objectives Non-vitamin K antagonist oral anticoagulants (NOACs) are an effective and safe alternative to warfarin in atrial fibrillation (AF) patients, but there is not enough evidence that NOACs can offer sufficient protection in AF patients concomitantly diagnosed with antiphospholipid syndrome (APS). Use of rivaroxaban has been associated with an increased risk of thrombotic events compared with warfarin in results of the TRAPS trial, but the TRAPS trial is not for AF patients and included only very high-risk APS patients with triple-positive for all 3 antiphospholipid antibodies. We sought to compare thromboembolic events, bleeding, and mortality between NOAC and warfarin in patients with both AF and APS. Methods From the Korean National Health Insurance Service (NHIS) database during the period from January 1, 2011 to December 31, 2016, we identified an warfarin-treated group of patients with AF and APS (n=1,237) who were compared with a 1:1 propensity-matched NOAC treated group (n=1,237). Results After a median follow-up period of 17 months, NOAC-treated patients had lower incidence rates for ischemic stroke (5.9 and 10.5 events per 100 person-years for the NOAC and warfarin groups), major bleeding (4.1 and 8.3 events per 100 person-years, respectively), and all-cause mortality (3.4 and 15.6 events per 100 person-years, respectively) compared with warfarin in patients with AF and APS. Compared with warfarin, NOAC significantly decreased the risk of ischemic stroke (hazard ratio [HR]: 0.60, 95% confidence interval [CI]: 0.47–0.77, p<0.001), major bleeding (HR: 0.54, 95% CI: 0.41–0.72, p<0.001) and all-cause mortality (HR: 0.32, 95% CI: 0.27–0.40, p<0.001) with considering competing risk of death. Conclusions Compared with warfarin, AF patients with APS on NOACs had lower ischemic stroke, major bleeding, and all-cause mortality. Our data suggest that AF patients with APS can be safely and effectively treated with NOACs. Funding Acknowledgement Type of funding source: None


2016 ◽  
Vol 2 (1) ◽  
pp. 46-53
Author(s):  
Kateryna Antonenko ◽  
Maurizio Paciaroni ◽  
Giancarlo Agnelli ◽  
Nicola Falocci ◽  
Cecilia Becattini ◽  
...  

Introduction Atrial fibrillation is an independent risk factor of thromboembolism. Women with atrial fibrillation are at a higher overall risk for stroke compared to men with atrial fibrillation. The aim of this study was to evaluate for sex differences in patients with acute stroke and atrial fibrillation, regarding risk factors, treatments received and outcomes. Methods Data were analyzed from the “Recurrence and Cerebral Bleeding in Patients with Acute Ischemic Stroke and Atrial Fibrillation” (RAF-study), a prospective, multicenter, international study including only patients with acute stroke and atrial fibrillation. Patients were followed up for 90 days. Disability was measured by the modified Rankin Scale (0–2 favorable outcome, 3–6 unfavorable outcome). Results Of the 1029 patients enrolled, 561 were women (54.5%) ( p < 0.001) and younger ( p < 0.001) compared to men. In patients with known atrial fibrillation, women were less likely to receive oral anticoagulants before index stroke ( p = 0.026) and were less likely to receive anticoagulants after stroke (71.3% versus 78.4%, p = 0.01). There was no observed sex difference regarding the time of starting anticoagulant therapy between the two groups (6.4 ± 11.7 days for men versus 6.5 ± 12.4 days for women, p = 0.902). Men presented with more severe strokes at onset (mean NIHSS 9.2 ± 6.9 versus 8.1 ± 7.5, p < 0.001). Within 90 days, 46 (8.2%) recurrent ischemic events (stroke/TIA/systemic embolism) and 19 (3.4%) symptomatic cerebral bleedings were found in women compared to 30 (6.4%) and 18 (3.8%) in men ( p = 0.28 and p = 0.74). At 90 days, 57.7% of women were disabled or deceased, compared to 41.1% of the men ( p < 0.001). Multivariate analysis did not confirm this significance. Conclusions Women with atrial fibrillation were less likely to receive oral anticoagulants prior to and after stroke compared to men with atrial fibrillation, and when stroke occurred, regardless of the fact that in our study women were younger and with less severe stroke, outcomes did not differ between the sexes.


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