Stroke/Thromboembolism and Intracranial Hemorrhage in a Real-world Atrial Fibrillation Population

CHEST Journal ◽  
2014 ◽  
Vol 146 (4) ◽  
pp. 1073-1080 ◽  
Author(s):  
Gualtiero Palareti ◽  
Luisa Salomone ◽  
Mario Cavazza ◽  
Marcello Guidi ◽  
Antonio Muscari ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Intracranial Hemorrhage ◽  
Real World

Abstract 12465: Dabigatran in Real World of Atrial Fibrillation: Systematic Review and Meta-analysis of Comparison Studies With Vitamin K Antagonists

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
João Carmo ◽  
Francisco M Costa ◽  
Jorge Ferreira ◽  
Miguel Mendes
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Systematic Review ◽  
Intracranial Hemorrhage ◽  
Vitamin K ◽  
Major Bleeding ◽  
Real World ◽  
Observational Studies ◽  
Meta Analysis ◽  
Vitamin K Antagonists

Background: In the clinical trial RE-LY, dabigatran showed a better efficacy/safety profile in comparison with warfarin, but clinical trials are few representative of the real world. We aim to access if dabigatran in real-world patients with atrial fibrillation (AF) showed a better profile in comparison with warfarin, through a systematic review and meta-analysis of observational studies comparing with vitamin K antagonists. Methods: PubMed, Embase and Scopus databases were searched through December 2014. We include observational studies comparing dabigatran to warfarin for non-valvular AF that reported clinical events during a follow-up for dabigatran 75mg, 110 mg or 150 mg, and warfarin. We proceeded to the extraction and analysis of data for clinical thromboembolic events, bleeding and mortality. Data were pooled by meta-analysis using a random-effects model. Results: We selected 9 studies involving a total of 291,703 patients, 85,399 treated with dabigatran and the remaining 206,304 with warfarin. The incidence of stroke was 1.71 / 100 patient-years for dabigatran and 2.44 / 100 patient years for warfarin (relative risk [RR] 0.91, 95% CI 0.66 to 1.27, p=0.58). The major bleeding rate was 3.90 / 100 patient-years for dabigatran and 3.92 / 100 patient years for warfarin (RR 0.90; 0.78 to 1.03, p=0.11). The all-cause mortality (RR 0.81, 0.75-0.88, p<0.001) and intracranial hemorrhage (RR 0.45, from 0.27 to 0.76, p=0.002) were significantly lower in patients treated with dabigatran in comparison to those treated with warfarin. There were no significant differences in risk of myocardial infarction (RR 0.55; 0.29 to 1.07, p=0.08), total hemorrhage (RR 1.00; 0.57 to 1.77, p=0.99), and gastro-intestinal bleeding (RR 1.14; 0.78 to 1.69, p=0.50). Conclusions: In this combined analysis of observational studies of real world, dabigatran compared to warfarin was associated with a similar risk of stroke, myocardial infarction, major bleeding, total bleeding and gastrointestinal bleeding, and a lower risk of intracranial hemorrhage and mortality.

Abstract 261: Applying Clinical Trial Data to Real-World: Apixaban, Dabigatran, and Rivaroxaban

2014 ◽  
Vol 7 (suppl_1) ◽  
Author(s):  
Alpesh Amin ◽  
Michael Stokes ◽  
Ning Wu ◽  
Elyse Gatt ◽  
Dinara Makenbaeva ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Relative Risk ◽  
Clinical Outcome ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Real World ◽  
Randomized Clinical Trials ◽  
Absolute Risk ◽  
The Real

BACKGROUND: Data from randomized controlled trials and a real-world sample of non-valvular atrial fibrillation patients were combined to estimate the absolute effect of each new oral anticoagulant (NOAC, apixaban, dabigatran, and rivaroxaban) versus warfarin on stroke and major bleeding rates in real-world clinical practice. METHODS: Non-valvular atrial fibrillation patients were selected from Medco healthplans during 2007-2010. Reference rates for stroke and major bleeding excluding intracranial hemorrhage (to avoid double counting) were calculated for real-world Medco patients during warfarin use. Real-world event rates for NOACs were estimated by multiplying the corresponding relative risk from the randomized clinical trials by each reference rate. Absolute risk reductions and numbers needed to treat (NNT) or numbers needed to harm (NNH) for each NOAC vs. warfarin were then estimated. Reduction in net clinical outcome was calculated by summing the absolute risk reductions for stroke and major bleeding excluding intracranial hemorrhage for each NOAC versus warfarin. RESULTS: Each NOAC resulted in a reduction in stroke events compared with warfarin in the real-world (TABLE). Apixaban was the only NOAC to reduce the rate of major bleeding excluding intracranial hemorrhage compared with warfarin. The NNT to avoid one net clinical outcome (stroke plus major bleeding excluding intracranial hemorrhage) per year was 32 and 84 for apixaban and dabigatran, respectively. Rivaroxaban resulted in an increase in net clinical outcome (NNH=166). CONCLUSIONS: If relative risk reductions from randomized clinical trials persist in the real-world, apixaban would result in the greatest clinical benefit versus warfarin of all NOACs in terms of stroke and major bleeding excluding intracranial hemorrhage events avoided.

scholarly journals Catheter ablation can improve survival with the reduction of heart failure in frail patients with atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Joung ◽  
P.S Yang ◽  
J.H Sung ◽  
E Jang ◽  
H.T Yu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Atrial Fibrillation ◽  
Acute Myocardial Infarction ◽  
Catheter Ablation ◽  
Real World ◽  
Background Characteristics ◽  
Risk Of Death ◽  
Frail Patients ◽  
Korean National Health Insurance

Abstract Background It is unclear whether catheter ablation is beneficial in frail patients with AF. Purpose This study aimed to evaluate whether catheter ablation reduces death and other outcomes in real-world frail patients with atrial fibrillation (AF). Methods Out of 801,710 patients with AF in the Korean National Health Insurance Service database from 2006 to 2015, 1,411 frail patients underwent AF ablations. The Hospital Frailty Risk Score were calculated retrospectively. Inverse probability of treatment weighting (IPTW) was used to categorize ablation and non-ablation frail groups. Results After IPTW, the two cohorts had similar background characteristics. During a median follow-up of 4.7 years (interquartile range: 2.2–7.8), the risk of death in frail patients with ablations was reduced by 65% compared to frail patients without ablations (2.0 and 6.4 per 100 person-years, respectively; hazard ratio [HR] 0.35; 95% confidence interval [CI] 0.25–0.50; P&lt;0.001). Ablations were related with a lower incidence and risk of heart failure admission (1.8 and 3.1 per 100 person-years, respectively; HR 0.66, 95% CI 0.44–0.98; P=0.042) and acute myocardial infarction (0.2 and 0.6 per 100 person-years, respectively; HR 0.30, 95% CI 0.15–0.62; P=0.001). However, the risk of stroke did not change after ablation. Conclussion Ablation may be associated with lower incidences of death, heart failure, and acute myocardial infarction in real-world frail patients with AF, supporting the role of AF ablation in these patients. The effect of frailty risk on the outcome of ablation should be evaluated in further studies. Funding Acknowledgement Type of funding source: None

scholarly journals Medication adherence to direct anticoagulants in patients with non-valvular atrial fibrillation – A real world analysis

2021 ◽  
Author(s):  
Catarina Brízido ◽  
António Miguel Ferreira ◽  
Pedro Lopes ◽  
Christopher Strong ◽  
Gustavo Sá Mendes ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Real World ◽  
Direct Anticoagulants

scholarly journals Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population

2021 ◽  
pp. 1-10
Author(s):  
Jeffrey S. Berger ◽  
François Laliberté ◽  
Akshay Kharat ◽  
Dominique Lejeune ◽  
Kenneth Todd Moore ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World

Direct Anticoagulants Versus Vitamin K Antagonists in Patients Aged 80 Years or Older With Atrial Fibrillation in a “Real-world” Nationwide Registry: Insights From the FANTASIIA Study

2020 ◽  
Vol 25 (4) ◽  
pp. 316-323
Author(s):  
Martín Ruiz Ortiz ◽  
Javier Muñiz ◽  
María Asunción Esteve-Pastor ◽  
Francisco Marín ◽  
Inmaculada Roldán ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Real World ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Anticoagulant Treatment ◽  
Cancer History

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26.0% vs 16.6%, P = .02) and previous major bleeding (8.1% vs 3.6%, P = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( P = .15), 3.45 vs 4.41 ( P = .48), and 8.2 vs 11.0 ( P = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, P = .19; HR: 0.88, 95% CI: 0.44-1.76, P = .72 and HR: 0.84, 95% CI: 0.53-1.33, P = .46, respectively). Conclusion: In this “real-world” registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.

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