Association of Rivaroxaban vs Apixaban With Major Ischemic or Hemorrhagic Events in Patients With Atrial Fibrillation

JAMA ◽  
2021 ◽  
Vol 326 (23) ◽  
pp. 2395
Author(s):  
Wayne A. Ray ◽  
Cecilia P. Chung ◽  
C. Michael Stein ◽  
Walter Smalley ◽  
Eli Zimmerman ◽  
...  
Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Dong Hoon Shin ◽  
Jaehun Jung ◽  
Gi Hwan Bae

Background: Atrial fibrillation (AF) should be treated with anticoagulants to prevent stroke and systemic embolism. Resuming anticoagulation after intracerebral hemorrhage (ICH) poses a clinical conundrum. The absence of evidence-based guidelines to address this issue has led to wide variations in restarting anticoagulation after ICH. This study aimed to evaluate the risks and benefits of anticoagulation therapy on all-cause mortality, severe thromboembolism, and severe hemorrhage and compare the effect of novel direct oral anticoagulants (NOACs) with warfarin on post-ICH mortality in patients with AF. Methods: This retrospective cohort study was performed using health insurance claim data obtained between 2002 and 2017 from individuals with newly developed ICH with comorbid AF. We excluded participants aged < 40 years and those with traumatic ICH, subdural hemorrhage, or subarachnoid hemorrhage. The primary endpoint was all-cause mortality, and the secondary endpoints were severe thrombotic and hemorrhagic events. Anticoagulants, antiplatelet agents, and non-users were analyzed for survival with propensity score matching. Results: Among 6735 participants, 1743 (25.9%) and 1690 (25.1%) used anticoagulants and antiplatelet agents, respectively. Anticoagulant (HR, 0.321; 95% CI, 0.264-0.390; P < 0.0001) or antiplatelet users (HR, 0.393; 95% CI, 0.330-0.468; P < 0.0001) had a lower risk of all-cause mortality than non-users. However, there was no difference between the two drug users (HR, 1.183; 95% CI, 0.94-1.487; P = 0.152; reference: anticoagulant). The risk of acute thrombotic events, although not hemorrhagic events, was significantly lower in anticoagulant users than in antiplatelet users. In addition, anticoagulation between 6 to 8 weeks post-ICH showed a tendency of the lowest risk of death. Further, NOACs were associated with a lower risk of all-cause mortality than warfarin. Conclusions: Our results showed that in patients with AF, resuming anticoagulants between 6 and 8 weeks after ICH improved all-cause mortality, severe thromboembolism, and severe hemorrhage. Further, compared with warfarin, NOAC had additional benefits.


2013 ◽  
Vol 77 (9) ◽  
pp. 2264-2270 ◽  
Author(s):  
Hiroshi Inoue ◽  
Ken Okumura ◽  
Hirotsugu Atarashi ◽  
Takeshi Yamashita ◽  
Hideki Origasa ◽  
...  

ABOUTOPEN ◽  
2018 ◽  
Vol 4 (1) ◽  
pp. 154-157
Author(s):  
Roberto Spoladore

Trans-catheter ablation of atrial fibrillation (AF) is a common treatment for symptomatic AF. Among the major complications of AF ablation are stroke, transient ischemic attacks and peri-procedural cardiac tamponade. Various clinical trials have shown that uninterrupted treatment with vitamin K antagonists (VKA) is associated with a lower incidence of embolic events compared to discontinuation of therapy; until recently, in the absence of equally solid evidence, this practice was not extended to the new oral anticoagulants (NOAC) not VKA due to the fear of hemorrhagic complications potentially associated with the use of an "irreversible" anticoagulant. The case of a patient suffering from numerous comorbidities is reported here. In light of the poor response to anti-arrhythmics, a TC-RF ablation was performed, with suspension of dabigatran administration only on the day of the procedure (for a total period <24 hours). Although the fear of the risk of bleeding potentially associated with the trans-catheter ablation procedure may still induce clinicians to stop anticoagulant therapy, even the decision to discontinue anticoagulant therapy with dabigatran on the day of surgery alone is challenged by recent evidence in the literature supporting the efficacy of dabigatran in reducing the incidence of hemorrhagic events during and after ablation, including the results of the RE-CIRCUIT study (Cardiology)


2015 ◽  
Vol 80 (3) ◽  
Author(s):  
Maurizio Giuseppe Abrignani ◽  
Vincenzo Abrignani

Robust evidence exists on the efficacy of traditional anticoagulant oral therapy in the prevention of thrombo-embolic risk in patients with non valvular atrial fibrillation, but fears and concerns of hemorrhagic events for the physicians and logistic difficulties related to the periodic International Normalized Ratio evaluation for the patients are at the basis of a noticeable under-utilization of the therapy with vitamin K antagonists in the real world. Stratification of the hemorrhagic risk has, thus, particular importance; for this objective we may use now several score system, among whom the more suggested is the HASBLED, with the principal aim to select and trait modifiable risk factors for bleeding. These score systems have been evaluated in some recent clinical trials. During the last years, a number of national and international guidelines on the prevention of the thrombo-embolic risk in patients with non valvular atrial fibrillation have been updated. These guidelines, generally, recommend the use of the CHA2DS2VaSC score for the evaluation of the thrombo-embolick risk, and of the HAS-BLED score for the evaluation of the hemorrhagic one. The consequent risk stratification is fundamental as a clinical guide for the use of oral anticoagulant therapy.


2018 ◽  
Vol 45 (3-4) ◽  
pp. 170-179 ◽  
Author(s):  
Keisuke Tokunaga ◽  
Hiroshi Yamagami ◽  
Masatoshi Koga ◽  
Kenichi Todo ◽  
Kazumi Kimura ◽  
...  

Background: We aimed to clarify associations between pre-admission risk scores (CHADS2, CHA2DS2-VASc, and HAS-BLED) and 2-year clinical outcomes in ischemic stroke or transient ischemic attack (TIA) patients with non-valvular atrial fibrillation (NVAF) using a prospective, multicenter, observational registry. Methods: From 18 Japanese stroke centers, ischemic stroke or TIA patients with NVAF hospitalized within 7 days after onset were enrolled. Outcome measures were defined as death/disability (modified Rankin Scale score ≥3) at 2 years, 2-year mortality, and ischemic or hemorrhagic events within 2 years. Results: A total of 1,192 patients with NVAF (527 women; mean age, 78 ± 10 years), including 1,141 ischemic stroke and 51 TIA, were analyzed. Rates of death/disability, mortality, and ischemic or hemorrhagic events increased significantly with increasing pre-admission CHADS2 (p for trend <0.001 for death/disability and mortality, p for trend = 0.024 for events), CHA2DS2-VASc (p for trend <0.001 for all), and HAS-BLED (p for trend = 0.004 for death/disability, p for trend <0.001 for mortality, p for trend = 0.024 for events) scores. Pre-admission CHADS2 (OR per 1 point, 1.52; 95% CI 1.35–1.71; p <0.001 for death/disability; hazard ratio (HR) per 1 point, 1.23; 95% CI 1.12–1.35; p <0.001 for mortality; HR per 1 point, 1.14; 95% CI 1.02–1.26; p = 0.016 for events), CHA2DS2-VASc (1.55, 1.41–1.72, p < 0.001; 1.21, 1.12–1.30, p < 0.001; 1.17, 1.07–1.27, p < 0.001; respectively), and HAS-BLED (1.33, 1.17–1.52, p < 0.001; 1.23, 1.10–1.38, p < 0.001; 1.18, 1.05–1.34, p = 0.008; respectively) scores were independently associated with all outcome measures. Conclusions: In ischemic stroke or TIA patients with NVAF, all pre-admission risk scores were independently associated with death/disability at 2 years and 2-year mortality, as well as ischemic or hemorrhagic events within 2 years.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Bergamaschi ◽  
A Stefanizzi ◽  
M Coriano ◽  
P Paolisso ◽  
I Magnani ◽  
...  

Abstract Background Several risk scores have been proposed to assess the bleeding risk in patients with Atrial Fibrillation. Purpose To compare the efficacy of HAS-BLED, ATRIA and ORBIT scores to predict major bleedings in newly diagnosed non-valvular AF (NV-AF) treated with vitamin K antagonists (VKAs) or new oral anticoagulants (NOACs). Methods We analyzed all consecutive patients with AF at our outpatient clinic from January to December 2017. Only those with new diagnosed NV-AF starting new anticoagulant therapy were enrolled. Major hemorrhagic events were defined according to the ISTH definition in non-surgical patients. Results Out of the 820 patients admitted with AF, 305 were newly diagnosed with NV-AF starting oral anticoagulation. Overall, 51.3% were male with a mean age of 72.6±13.7 years. Thirty-six patients (11.8%) started VKAs whereas 269 (88.2%) patients were treated with NOACs. The median follow-up time was 10.4±3.4 months. During follow-up, 123 (32.2%) bleeding events were recorded, 21 (17,1%) in the VKA group and 102 (82,9%) in the NOAC group. Eleven (2.9%) major bleeding events occurred: 5 (45.5%) in the VKA group and 6 (54.5%) in the NOAC group. Overall, patients with major hemorrhagic events showed a mean value of the scores significantly higher when compared to patients without such bleeding complications (HASBLED 3.4 vs 2.4 p=0.007; ATRIA 5.6 vs 2.4 p<0.001; ORBIT 3.6 vs 1.8 p<0,001). Conversely, when analyzing the VKA subgroup, only the ATRIA score was significantly higher in patients with major adverse events (7.4 vs 3.5 p<0.001; HAS-BLED: 4.4 vs 3.6 p=0.27; ORBIT 4.4 vs 2.9 p=0.13). An ATRIA score ≥4 identified patients at high risk of bleeding (29.4% vs. 0% events. respectively, p=0.04). In the NOAC group, patients with major bleeding events had higher mean values of ATRIA (4.0 vs 2.3 p=0.02) and ORBIT (2.8 vs 1.6 p=0,04) but not the HAS-BLED (2.5 vs 2.3 p=0.57) scores. Similarly, patients on NOACs with an ATRIA score ≥4 had higher rates of major bleedings (8.1% vs. 1.6% p=0,02). Comparing the single elements of the ATRIA score, only glomerular filtration rate <30 ml/min/1.73 mq was associated with major bleedings in the VKA group (p<0.001) whereas, in the NOAC group, anemia was strongly associated with bleeding events (p=0,02). In fact, multivariate analysis in the NOAC group showed that hemoglobin level at admission was an independent predictor for major bleeding events (OR 0.41, 95% CI 0.23–0.75, P=0.003). Conversely, in the VKA group, baseline creatinine level was an independent predictor for these events (OR 12.76, 95% CI 1.6–101.7, P=0.016). Conclusions The ATRIA score showed the best efficacy in predicting major bleeding events. Hemoglobin and creatinine levels at admission were independent predictors for major hemorrhagic events in the NOAC and in the VKA groups, respectively. The latter finding might be helpful in stratifying the hemorrhagic risk at the beginning of treatment.


Author(s):  
L. N. Uddin ◽  
A. A. Sokolova ◽  
A. V. Egorov ◽  
D. A. Napalkov ◽  
V. V. Fomin ◽  
...  

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Pasquale Santangeli ◽  
Luigi Di Biase ◽  
Javier E. Sanchez ◽  
Rodney Horton ◽  
Andrea Natale

Atrial fibrillation (AF) can be cured by pulmonary vein antrum isolation (PVAI) in a substantial proportion of patients. The high efficacy of PVAI is partially undermined by a small but concrete periprocedural risk of complications, such as thromboembolic events and bleeding. A correct management of anticoagulation is essential to prevent such complications. Performing PVAI without interruption of oral anticoagulation has been demonstrated feasible by our group in previous studies. Recently, we reported that continuation of therapeutic warfarin during radiofrequency catheter ablation consistently reduces the risk of periprocedural stroke/transient ischemic attack without increasing the risk of hemorrhagic events. Of note, interrupting warfarin anticoagulation may actually increase the risk of stroke even when bridged with heparin. The latter strategy is also associated with an increased risk of minor bleeding. With regard to major bleeding, we found no significant difference between patients with a therapeutic INR and those who were bridged with heparin. Therefore, continuation of therapeutic warfarin during ablation of AF appears to be the best anticoagulation strategy. In this paper we summarize our experience with AF ablation without interruption of anticoagulation.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Mariana Sousa ◽  
Pedro Bravo ◽  
Cristina Santos ◽  
Aura Ramos

Abstract Background and Aims Patients with renal replacement therapy and atrial fibrillation (AF) have a particularly high risk of both stroke and bleeding, but no high-quality evidence-based recommendations exist to properly manage these patients. Therefore, we aim to evaluate the ischaemic versus the haemorrhagic risk in a hemodialysis (HD) population. Method We selected patients that started hemodialysis in our hospital between 2011 and 2015. Only incident patients that were on regular hemodialysis treatment for more than 3 months were considered. Both patients that already had AF before HD, or developed AF during the follow-up, were included. At the time of AF diagnosis or beginning of HD, the risk factors were analyzed based on CHA2 DS2 -VASC and HAS-BLED scores. The outcomes were hemorrhagic events (only the events that needed hospitalization were taken into account), ischaemic events (i.e. that result from embolic arterial ischaemia) and death related to any of these events. Results From 302 incident patients on hemodialysis, 46 (15.23 %) were included. Mainly man (65%), with a mean age of 75 ± 10 years old. Most of the patients (63%) already had AF when they started hemodialysis. There was no significant difference between the incidence of ischaemic and haemorrhagic events (p=0.219). Three patients died of an ischemic event and two of haemorrhagic shock.Twenty one patients (45.6%) started oral anticoagulation. No difference was found between the proportion of haemorrhagic events between patients with oral anticoagulation and patients with no anticoagulation (p=0.157). Similarly, oral anticoagulation was not associated with any effect on the incidence of ischaemic events (p=0.366). The results after adjustment for the risk factors included in the HAS-BLED and CHA2 DS2-VASC scores were the same. Previous stroke, transient ischaemic attack or thromboembolic event significantly increased the risk of an ischaemic event, when adjusted to oral anticoagulation, age, diabetes, vascular disease and hypertension (OR 6.78, C.I 95% 1.236-37.278, p=0.028). This risk factor was not associated with an increase of haemorrhagic events. No other risk factor included in the scores was associated with any significant effect in the outcomes. Conclusion As we know, AF increases the risk of ischaemic events in general population. However, in hemodialysis patients, we didn’t observe any difference between the incidence of ischaemic and haemorrhagic events. Therefore, the benefit of oral anticoagulation in such patients remains questionable. It is worth noting that patients with previous stroke, transient ischemic attack or thromboembolic event seem to have higher risk of new ischaemic events. In these patients, there may be some advantage in oral anticoagulation. Since this is a single center, retrospective, observational study, these results should be interpreted with caution.


Sign in / Sign up

Export Citation Format

Share Document