The CHA2DS2-VASc Score Predicts Major Bleeding in Non-Valvular Atrial Fibrillation Patients Who Take Oral Anticoagulants

Background: Patients with atrial fibrillation (AF) are at a substantial risk of ischemic stroke. The CHA2DS2-VASc score predicts the risk of thromboembolism, but its role in predicting major bleeding in patients taking oral anticoagulants is unclear. Methods: We used the National Health Insurance Research Database (NHIRD) of Taiwan to identify patients with AF from 2010 to 2016. They were divided into four groups according to the oral anticoagulants. The outcomes were ischemic stroke/systemic thromboembolism, and major bleeding. Results: A total of 279,776 patients were identified. Ischemic stroke or systemic embolism events were observed in 1.73%, 3.62%, 4.36%, and 5.02% of the patients in the apixaban, rivaroxaban, dabigatran, and warfarin groups, respectively. Major bleeding was recorded in 1.18%, 2.66%, 3.23%, and 4.70% of the patients in the apixaban, rivaroxaban, dabigatran, and warfarin groups, respectively. The highest rates for both ischemic stroke and bleeding events occurred in the patients with a CHA2DS2-VASc score of five or more. Conclusion: Non-valvular AF patients with high CHA2DS2-VASc scores are susceptible to both systemic thromboembolism and major bleeding. The trend was consistently observed in patients who took non-vitamin K oral anticoagulants (NOACs) or warfarin. NOACs might be potentially more effective in reducing overall events.

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

Blood ◽

10.1182/blood-2019-125150 ◽

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.

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Early Initiation of Direct Oral Anticoagulants After Onset of Stroke and Short- and Long-Term Outcomes of Patients With Nonvalvular Atrial Fibrillation

Stroke ◽

10.1161/strokeaha.119.028118 ◽

2020 ◽

Vol 51 (3) ◽

pp. 883-891 ◽

Cited By ~ 2

Author(s):

Tadataka Mizoguchi ◽

Kanta Tanaka ◽

Kazunori Toyoda ◽

Sohei Yoshimura ◽

Ryo Itabashi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Hazard Ratio ◽

Interquartile Range ◽

Systemic Embolism ◽

Nonvalvular Atrial Fibrillation ◽

Ischemic Attack

Background and Purpose— We aimed to compare outcomes of ischemic stroke patients with nonvalvular atrial fibrillation between earlier and later initiation of direct oral anticoagulants (DOACs) after stroke onset. Methods— From data for 1192 nonvalvular atrial fibrillation patients with acute ischemic stroke or transient ischemic attack in a prospective, multicenter, observational study, patients who started DOACs during acute hospitalization were included and divided into 2 groups according to a median day of DOAC initiation after onset. Outcomes included stroke or systemic embolism, major bleeding, and death at 3 months, as well as those at 2 years. Results— DOACs were initiated during acute hospitalization in 499 patients in median 4 (interquartile range, 2–7) days after onset. Thus, 223 patients (median age, 74 [interquartile range, 68–81] years; 78 women) were assigned to the early group (≤3 days) and 276 patients (median age, 75 [interquartile range, 69–82] years; 101 women) to the late (≥4 days) group. The early group had lower baseline National Institutes of Health Stroke Scale score and smaller infarcts than the late group. The rate at which DOAC administration persisted at 2 years was 85.2% overall, excluding patients who died or were lost to follow-up. Multivariable Cox shared frailty models showed comparable hazards between the groups at 2 years for stroke or systemic embolism (hazard ratio, 0.86 [95% CI, 0.47–1.57]), major bleeding (hazard ratio, 1.39 [95% CI, 0.42–4.60]), and death (hazard ratio, 0.61 [95% CI, 0.28–1.33]). Outcome risks at 3 months also did not significantly differ between the groups. Conclusions— Risks for events including stroke or systemic embolism, major bleeding, and death were comparable whether DOACs were started within 3 days or from 4 days or more after the onset of nonvalvular atrial fibrillation–associated ischemic stroke or transient ischemic attack. Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT01581502.

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P4787Use of direct oral anticoagulants in patients with atrial fibrillation having a history of intracranial hemorrhage

European Heart Journal ◽

10.1093/eurheartj/ehz745.1163 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T F Chao ◽

S A Chen

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Intracranial Hemorrhage ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Research Database ◽

Bleeding Events ◽

Risk Of Mortality ◽

Taiwan National Health Insurance ◽

History Of

Abstract Background Patients with atrial fibrillation (AF) having a history of intracranial hemorrhage (ICH) were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. We aimed to compare the effectiveness and safety of DOACs and warfarin among AF patients having a history of ICH. Method A total of 4,540 AF patients having a CHA2DS2-VASc score ≥1 for males and ≥2 for females who had a history of ICH and received oral anticoagulants (DOACs in 3,493 and warfarin in 1,047) were identified from the Taiwan National Health Insurance Research Database. A propensity matching analysis was performed to balance the baseline differences, and 973 patients were finally identified in each groups. Results The risk of ischemic stroke did not differ significantly between warfarin and DOACs (4.41%/yr vs 4.87%/yr; HR 0.985, p=0.927). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.752 (0.573–0.986, p=0.040) for major bleeding and 0.614 (0.379–0.995, p 0.048) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR = 0.539; 95% CI = 0.453–0.642, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. Conclusion Compared to warfarin, DOACs were associated with a similar risk of ischemic stroke and better safety profiles among AF patient with a history of ICH.

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

European Heart Journal - Cardiovascular Pharmacotherapy ◽

10.1093/ehjcvp/pvaa079 ◽

2020 ◽

Cited By ~ 1

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.

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P4789Comparisons of direct oral anticoagulants and warfarin in patients with atrial fibrillation and liver cirrhosis

European Heart Journal ◽

10.1093/eurheartj/ehz745.1165 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T F Chao ◽

G Y H Lip ◽

S A Chen

Keyword(s):

Atrial Fibrillation ◽

Liver Cirrhosis ◽

Major Bleeding ◽

Lower Risk ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Research Database ◽

Bleeding Events ◽

Risk Of Mortality ◽

Taiwan National Health Insurance

Abstract Background Patients with atrial fibrillation (AF) and severe liver cirrhosis were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. In the present study, we compared the effectiveness and safety of DOACs and warfarin among AF patients with liver cirrhosis. Method A total of 3,691 AF patients with liver cirrhosis having a CHA2DS2-VASc score ≥1 for males and ≥2 for females and received oral anticoagulants (DOACs in 2,548 and warfarin in 1,143) were identified from the Taiwan National Health Insurance Research Database. The effectiveness and safety were compared between DOACs and warfarin groups. Results There was a trend suggesting a lower risk of ischemic stroke with DOACs compared to warfarin (2.91%/yr vs 3.41%/yr; HR 0.743, p=0.060). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.718 (0.573–0.899, p=0.004) for major bleeding and 0.509 (0.292–0.889, p=0.018) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR=0.483; 95% CI: 0.424–0.551, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. The results were essentially similar after the propensity matching analysis of 2 groups. Conclusion Compared to warfarin, DOACs were associated with a lower risk of ICH, major bleeding and mortality among AF patient with liver cirrhosis.

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Clinical significances of prothrombin time-international normalized ratio and activated partial thromboplastin time in patients with atrial fibrillation treated with direct oral anticoagulants

European Heart Journal ◽

10.1093/eurheartj/ehab724.0593 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

T Chao ◽

Y.H Chan ◽

S.A Chen

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Randomized Trials ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

International Normalized Ratio ◽

Systemic Embolism ◽

Bleeding Events ◽

Factors Associated ◽

Funding Sources

Abstract Background Although the measurements of PT-INR or aPTT were not performed for patients with atrial fibrillation (AF) taking direct oral anticoagulants (DOACs) in randomized trials, these tests were commonly used and familiar to clinical physicians. We aimed to test whether there is an association between PT-INR or aPTT ratio and risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding among AF patients taking rivaroxaban or dabigatran, respectively. Methods This multi-center cohort study included 3,192 AF patients taking rivaroxaban and 958 patients taking dabigatran for stroke prevention whose data about PT-INR and aPTT were available. Results For patients treated with rivaroxaban, a higher INR level was not associated with a higher risk of major bleeding compared to an INR level <1.1. The risk of IS/SE was lower for patients having an INR ≥1.5 compared to those with an INR <1.1 (aHR: 0.57; [95% CI: 0.37–0.87]; P=0.0088) (Figure). On-label dosing of rivaroxaban and use of digoxin were independent factors associated with an INR ≥1.5 after taking rivaroxaban. For patients taking dabigatran, a higher aPTT ratio was not associated with a higher risk of major bleeding. The risk of IS/SE was lower for patients having an aPTT ratio of 1.1–1.2 and 1.3–1.4 than those with an aPTT ratio <1.1. Conclusions In Asian AF patients, PT-INR or aPTT ratios were not associated with the occurrences of bleeding events for rivaroxaban or dabigatran. Patients taking rivaroxaban with an INR ≥1.5 were associated with a lower risk of IS/SE. Appropriate dosages of DOACs and the compliances of patients should be confirmed for patients taking rivaroxaban with an INR <1.5. FUNDunding Acknowledgement Type of funding sources: None.

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Abstract 215: Efficacy and Safety of Novel Oral Anticoagulants (NOACs) in Asian population with Non-Valvular Atrial Fibrillation (NVAF) - A Meta-Analysis

Stroke ◽

10.1161/str.46.suppl_1.215 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Mayumi Fukuda ◽

Daniel E Singer ◽

Paul A Bain ◽

Shoichiro Sato ◽

Daiki Kobayashi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Hemorrhagic Stroke ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Asian Population ◽

Phase Iii ◽

Efficacy And Safety ◽

Systemic Embolism ◽

Bleeding Events

Background and purpose: Asians have higher risk of intracranial hemorrhage (ICH) compared to non-Asians. Although recent clinical trials have shown non-vitamin K antagonist oral anticoagulants (NOACs) were favorable in preventing ICH as well as thrombotic events among patients with non-valvular atrial fibrillation (NVAF), it is unclear whether the efficacy and safety of NOACs are consistent among Asians. The purpose of this study is to assess the efficacy and safety of NOACs in Asians with NVAF. Methods: PubMed, Embase, Cochrane Central, Web of Science, the Western Pacific Index Medicus, Clinicaltrials.Gov and supplemented with conference abstracts were searched up to June 2014. Phase III randomized control trials that reported efficacy and safety of NOACs vs. warfarin in Asians and non-Asians with NVAF were identified. Each study was reviewed by two reviewers and differences were resolved by consensus. The end points analyzed were all stroke or systemic embolism, ischemic and hemorrhagic stroke, major or clinically relevant non major bleeding events (CRNM), and ICH. The hazard ratio (HR) with 95% confidence interval (CI) of each endpoint in NOACs compared to warfarin was extracted separately among Asians and non-Asians. Random-effects models were used to calculate pooled HR and 95% CI. Results: 5 eligible studies were identified. Total of 8928 Asians and 64023 non-Asians were included. All stroke or systemic embolism were significantly reduced with NOACs in Asians (HR: 0.72 [95% CI: 0.59-0.88], p=0.002) but not in non-Asians (HR: 0.82 [0.66-1.01], p=0.097). The risk of ischemic stroke was not decreased in Asians (HR: 0.88 [0.64-1.21], p=0.43) or non-Asians (HR: 0.98 [0.80-1.12], p=0.73), whereas the risk of hemorrhagic stroke was significantly decreased in both groups (HR: 0.28 [0.17-0.47], p<0.001 for Asians, HR: 0.37 [0.24-0.55], p<0.001, respectively). The risk of major bleeding or CRNM was significantly reduced in Asians (HR: 0.68 [0.56-0.83], p<0.001) but not in non-Asians (HR: 0.78 [0.60-1.0], p=0.21). The risk of ICH was significantly decreased in both groups (HR: 0.30 [0.21-0.42], p<0.001, HR: 0.41 [0.34-0.48], p<0.001, respectively). Conclusions: The efficacy and safety of NOACs in Asians with NVAF is consistent with the overall results.

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Oral anticoagulation in patients with chronic kidney disease

Neurology ◽

10.1212/wnl.0000000000007534 ◽

2019 ◽

Vol 92 (21) ◽

pp. e2421-e2431 ◽

Cited By ~ 13

Author(s):

Konark Malhotra ◽

Muhammad F. Ishfaq ◽

Nitin Goyal ◽

Aristeidis H. Katsanos ◽

John Parissis ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Ischemic Stroke ◽

Kidney Disease ◽

Major Bleeding ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Factor Xa ◽

Sensitivity Analyses ◽

Systemic Embolism ◽

Bleeding Events

ObjectiveData regarding the efficacy and safety of warfarin and non-vitamin K antagonist oral anticoagulant (NOAC) among patients with chronic kidney disease (CKD) remain scarce.MethodsSystematic review and meta-analysis of studies involving patients with CKD treated with oral anticoagulants were conducted to evaluate the following outcomes: ischemic stroke, intracerebral hemorrhage (ICH), combined ischemic and hemorrhagic stroke (strokecombined), stroke or systemic embolism, mortality, and major bleeding events. CKD was defined based on creatinine clearance (CrCl) ranging from mild (CrCl: 60–89 mL/min), moderate (CrCl: 30–59 mL/min), to severe (CrCl: 15–29 mL/min).ResultsFifteen studies (7 comparing NOAC vs warfarin and 8 comparing warfarin vs no anticoagulant) were identified comprising 78,053 patients. Warfarin (vs no anticoagulant) was associated with reduced risk of ischemic stroke (risk ratio [RR] = 0.68; 95% confidence interval [CI] 0.55–0.84]) and mortality (RR = 0.70; 95% CI 0.62–0.78). In comparison to warfarin, NOAC use lowered the risk of ICH (RR = 0.43; 95% CI 0.33–0.56), strokecombined (RR = 0.83; 95% CI 0.72–0.96), stroke or systemic embolism (RR = 0.73; 95% CI 0.62–0.85), and major bleeding (RR = 0.77; 95% CI 0.66–0.90). In adjusted analyses, warfarin use (vs no anticoagulant) was associated with reduced mortality (HRadj = 0.68; 95% CI 0.61–0.76), whereas NOAC (vs warfarin) use reduced the risk of ICH (HRadj = 0.39; 95% CI 0.30–0.50) and stroke or systemic embolism (HRadj = 0.75; 95% CI 0.65–0.88). Our sensitivity analyses comparing different NOACs exhibited that factor Xa inhibitors (compared to warfarin) consistently reduced strokecombined (RR = 0.84; 95% CI 0.73–0.96), mortality (RR = 0.84; 95% CI 0.70–1.00), ICH (RR = 0.45; 95% CI 0.24–0.85), and major bleeding (RR = 0.76; 95% CI 0.64–0.91).ConclusionsAmong patients with CKD treated with oral anticoagulants, NOACs present with a more favorable safety and efficacy profile for various cardiovascular outcomes.

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Apixaban versus Warfarin in Patients with Left Ventricular (LV) Thrombus, a prospective randomized trial

European Heart Journal ◽

10.1093/ehjci/ehaa946.1545 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

R Alcalai ◽

R Rashad ◽

A Butnaru ◽

G Moravsky ◽

D Leibowitz

Keyword(s):

Major Bleeding ◽

Thrombus Formation ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Left Ventricular ◽

Systemic Embolism ◽

Bleeding Events ◽

Open Label ◽

Warfarin Group ◽

Acute Mi

Abstract Background Patients with acute myocardial infarction (MI) have an elevated risk of stroke, mostly due to left ventricular (LV) thrombus formation, which typically occur within the first 2 weeks following an anterior MI. Currently the recommended management of LV thrombus after acute MI is anticoagulation with vitamin K antagonist. To date, there are no prospective data on the use of direct oral anticoagulants (DOACS) for stroke prevention in the setting of LV thrombus. Aim To assess the efficacy of apixaban vs. warfarin in treating LV thrombus after MI. Methods The study is a prospective, randomized, multi-center open label trial comparing apixaban (at a dose of 5 mg twice daily) with s.c enoxaparin 1mg/kg BID followed by dose-adjusted warfarin to achieve a target international normalized ratio (INR) of 2.0 to 3.0 for 3 months in patients with LV thrombus detected by echocardiography 3 to 14 days after acute MI. The primary outcome was the presence and size of LV thrombus 3 months after initiation of anticoagulation as assessed by 2D echocardiogram. Secondary outcomes were stroke or systemic embolism, major bleeding and death from any cause. Results 25 patients have been enrolled to date in 3 medical centers, 13 were randomized to apixaban and 12 to warfarin. Mean age was 59.8±10.7 and 19 (76%) were males with no difference between the study groups. Mean LV thrombus size at enrollment was 24X15 mm in the apixaban group and 19X14 in the warfarin group (p=NS). After 3 months of treatment thrombus completely resolved in all patients in the warfarin group and in 12 of 13 in the apixaban group. In one patient in the apixaban group who had a very large thrombus of 40x20mm size upon enrollment the thrombus size was reduced significantly to 20x12 after 3 months. No death, stroke or systemic embolism was documented in either group. There were two patients with major bleeding in the warfarin group, one had sub-arachnoid hemorrhage after 2 months and anticoagulation was stopped, and another had GI bleeding after 1 month and was switched to enoxaparin. One patient in the warfarin group refused to continue the treatment after 3 weeks. No major bleeding events were recorded in the apixaban group and all patients completed 3 months of treatment. Conclusions Our preliminary results indicate that apixaban is a safe and effective treatment for patients with LV thrombus post anterior wall MI. Funding Acknowledgement Type of funding source: None

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Safety of early anticoagulation in patients treated with urgent reperfusion for acute ischemic stroke related to non-valvular atrial fibrillation

European Heart Journal ◽

10.1093/ehjci/ehaa946.2431 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Giustozzi

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Major Bleeding ◽

Oral Anticoagulation ◽

Primary Outcome ◽

Oral Anticoagulants ◽

Early Recurrence ◽

Optimal Timing ◽

Hemorrhagic Event

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

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