scholarly journals Safety and Efficacy of Non-Vitamin K Antagonists in Atrial Fibrillation in the real world: A pooled-analysis and comparison of XANTUS and ETNA-AF-EU studies

2021 ◽  
Author(s):  
Hilaryano Ferreira ◽  
Humberto Morais ◽  
Joao Augusto ◽  
Ana Rita Ferreira ◽  
Francisco Madeira ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiovascular Mortality ◽  
Real World ◽  
Vitamin K Antagonists ◽  
Pooled Analysis ◽  
Unadjusted Odds Ratio ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
All Cause Mortality ◽  
Safety Outcomes

Abstract Background: This study aims to assess the efficacy and safety of treatment with edoxaban or rivaroxaban for stroke prevention in patients with atrial fibrillation. Methods: Pooled analysis from two real-world cohorts. Efficacy outcomes were all-cause mortality, cardiovascular mortality and thromboembolic events at 1 year. Safety outcomes were assessed by major or nonmajor bleeding. Results: A total of 19876 patients were enrolled in both trials. All-cause mortality at 1 year was lower in the rivaroxaban group (118 of 6784 patients [1.7%]) than in the edoxaban group (442 of 13092 patients [3.5%]) (unadjusted odds ratio was 1.97 (95% CI, 1.61 to 2.42; P=<0.00001). Cardiovascular mortality was edoxaban (206 of 13092 patients [1.63%]) vs rivaroxaban 49 of 6784 patients [0.72%]) (unadjusted OR, 2.20; 95% CI, 1.61 to 3.00; p=<0.00001). Overall, the efficacy outcomes favoured the rivaroxaban cohort (OR 1.97, 95% CI, 1.33 to 2.91; P=0.0002), with no significant difference in ischaemic stroke between the two cohorts (unadjusted OR 1.13, 95% CI, 0.75 to 1.73; P=0.56). Overall, safety outcomes tended to occur more often in the edoxaban cohort (unadjusted OR 0.43, 95% CI, 0.20 to 0.40; P=<0.00001). Conclusion: Rivaroxaban and edoxaban seem to be effective and safe. However, real-world prospective studies evaluating safety and efficacy in certain subgroups are needed.

scholarly journals Effectiveness and safety of dabigatran compared to vitamin K antagonists in patients with atrial fibrillation: a systematic review and metanalysis.

2021 ◽  
Author(s):  
Carlos Escobar Cervantes ◽  
Vivencio Barrios ◽  
Gregory Y.H. Lip ◽  
Alpesh N. Amin ◽  
Ariadna Auladell-Rispau ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Vitamin K ◽  
Real World ◽  
Vitamin K Antagonists ◽  
Bleeding Risk ◽  
Fatal Bleeding ◽  
Prisma Statement ◽  
All Cause Mortality ◽  
Safety Outcomes

Abstract Purpose: To assess the comparative effectiveness and safety of dabigatran ‒globally and stratified by dose (110 or 150 mg b.i.d.) compared to vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation (NVAF) from “real world” studies.Methods: A systematic review was performed according to Cochrane methodological standards. The results were reported according to the PRISMA statement. The ROBINS-I tool was used to assess risk of bias.Results: A total of 25 studies, corresponding to 27 articles involving 771.468 participants (490.082 exposed to VKA and 281.386 to dabigatran) were eligible for this review. Dabigatran reduced the risk of ischemic stroke compared to VKA, particularly dabigatran 150 mg, with a 15% risk reduction (HR 0.85, 95%CI 0.74-0.98). Globally, dabigatran reduced the risk of all-cause mortality compared to VKA (HR 0.75, 95%CI 0.67-0.85), with a greater effect observed with dabigatran 150 mg (HR 0.66, 95%CI 0.58-0.74). There was a trend towards a lower risk of myocardial infarction with dabigatran 150 mg (HR 0.86, 95%CI 0.71-1.04). Regarding the primary safety outcomes, dabigatran (either at a dose of 150 mg or 110 mg) reduced the risk of major bleeding compared to VKA (HR 0.74, 95%CI 0.66-0.83), as well as the risk of intracranial bleeding (HR 0.45, 95%CI 0.39-0.52) and fatal bleeding (HR 0.76, 95%CI 0.60-0.95), but with a non-significant trend towards a higher gastrointestinal bleeding risk (HR 1.08, 95%CI 0.99 to 1.18). Conclusion: Dabigatran has a favourable impact in effectiveness and safety outcomes compared to VKA in real-world populations.

Dabigatran in real-world atrial fibrillation

2016 ◽  
Vol 116 (10) ◽  
pp. 754-763 ◽  
Author(s):  
Francisco Moscoso Costa ◽  
Jorge Ferreira ◽  
Miguel Mendes ◽  
João Carmo
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Real World ◽  
Vitamin K Antagonists ◽  
Intracranial Bleeding ◽  
Gi Bleeding ◽  
Stroke Incidence ◽  
Significant Difference

SummaryIn the RE-LY clinical trial, dabigatran presented a better effectiveness/ safety profile when compared to warfarin. However, clinical trials are not very representative of the real-world setting. We aimed to assess the performance of dabigatran in real-world patients with atrial fibrillation (AF) by means of a systematic review and meta-analysis of observational comparison studies with vitamin K antagonists (VKA). We searched PubMed, Embase and Scopus databases until November 2015 and selected studies according to the following criteria: observational study performed with nonvalvular AF patients; reporting adjusted hazard ratios (HR) of clinical events in a follow-up period; for dabigatran 75 mg, 110 mg or 150 mg versus VKA. Twenty studies were selected which included 711,298 patients, 210,279 of which were treated with dabigatran and the remaining 501,019 with VKA. Ischaemic stroke incidence was of 1.65 /100 patient-years for dabigatran and 2.85/100 patient-years for VKA (HR 0.86, 95 % confidence interval of 0.74–0.99). Major bleeding rate was 3.93/100 patient-years for dabigatran and 5.61/100 patient-years for VKA (0.79, 0.69–0.89). Risk of mortality (0.73, 0.61–0.87) and intracranial bleeding (0.45, 0.38–0.52) were significantly lower in patients treated with dabigatran when compared to patients on VKA. Risk of gastrointestinal (GI) bleeding was significantly higher in patients treated with dabigatran (1.13, 1.00–1.28). No significant difference was observed in risk of myocardial infarction (0.99, 0.89–1.11). In this combined analysis of real-world observational comparison studies with VKA, dabigatran was associated with a lower risk of ischaemic stroke, major bleeding, intracranial bleeding and mortality, higher risk of GI bleeding and a similar risk of myocardial infarction.Supplementary Material to this article is available online at www.thrombosis-online.com.

Relation of Renal Dysfunction to Quality of Anticoagulation Control in Patients with Atrial Fibrillation: The FANTASIIA Registry

2018 ◽  
Vol 118 (02) ◽  
pp. 279-287 ◽  
Author(s):  
María Esteve-Pastor ◽  
José Rivera-Caravaca ◽  
Inmaculada Roldán-Rabadán ◽  
Vanessa Roldán ◽  
Javier Muñiz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Cardiovascular Mortality ◽  
Real World ◽  
Cardiovascular Events ◽  
Vitamin K Antagonists ◽  
Major Adverse Cardiovascular Events ◽  
Anticoagulation Control

Background One-third of atrial fibrillation (AF) patients have chronic kidney disease (CKD), a condition that itself increases thromboembolic and major bleeding risks, especially in patients with severe CKD. Bleeding would be accentuated by suboptimal anticoagulation control with vitamin K antagonists (VKA). Purpose This article aimed to investigate the incidence of cardiovascular events, mortality and quality of anticoagulation in relation to CKD in a ‘real-world’ prospective cohort of AF patients included in the FANTASIIA registry. Methods We analysed consecutive AF patients who were prospectively recruited with a year of follow-up. The quality of anticoagulation was estimated by time in therapeutic range (TTR). The annual incidence of events was analysed. Results We studied 1,936 patients (male: 55.7%, mean: 73.8 ± 9.4 years): 445 (22.9%) had normal function, 698 (36.1%) had mild CKD, 713 (36.8%) had moderate CKD and 80 (4.2%) had severe CKD. Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (severe CKD) had lower TTR (53.3 ± 25.6% vs. 61.8 ± 25.1%, p = 0.007) and higher proportion of poor TTR (67.2 vs. 51.8%; p = 0.014) than patients with eGFR ≥30 mL/min/1.73 m2. Severe CKD was significantly associated with cardiovascular mortality (hazard ratio [HR]: 9.33; p = 0.002), major bleeding (HR: 2.94; p = 0.036) and major adverse cardiovascular events (MACE) (HR: 4.93; p = 0.004). Importantly, 375 patients (21.1%) showed a deteriorating eGFR of ≥10 mL/min during the follow-up, with significantly higher mortality and cardiovascular events. Conclusion In a prospective and real-world AF registry, approximately 67% of patients with severe CKD had poor anticoagulation control while taking VKA. The presence of severe CKD was an independent factor for cardiovascular mortality, MACE and major bleeding. Worsening eGFR of only ≥10 mL/min during follow-up was significantly associated with mortality and major bleeding.

P4800Estimated effect of NOACs compared to Vitamin K Antagonists in real-world atrial fibrillation patients: Data from FANTASIA Registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M A Esteve Pastor ◽  
J M Rivera-Caravaca ◽  
V Roldan ◽  
I Roldan Rabadan ◽  
J Muniz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Vitamin K ◽  
Major Bleeding ◽  
Real World ◽  
Absolute Risk ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Stroke Rate ◽  
All Cause Mortality

Abstract Background Despite of the effectiveness and safety profile of Non-vitamin K Antagonists Oral Anticoagulants (NOACs) even in real-world (RW) Atrial Fibrillation (AF) patients, Vitamin K Antagonists (VKAs) have remained widely used in clinical practice worldwide but the comparison with acenocoumarol therapy in RW is unknown. Purpose To estimate the potential absolute benefit in clinical adverse events if the AF patients anticoagulated with VKA therapy had been treated with NOACs. Methods We analyzed anticoagulated AF patients who were prospectively recruited into the multicentre FANTASIIA registry. Patients were treated with VKAs for at least 6 months prior to inclusion. The estimation of clinical adverse events avoided was calculated applying absolute risk reductions, relative risk reductions and hazard ratios from the meta-analysis of RW use of NOACs relative to VKAs. Results We analyzed 1,470 patients under VKA therapy (mean age 74.1±9.5 years; 56.4% male). Stroke rate with acenocoumarol treatment was 0.88%/year. The estimated rates for stroke using NOACs would be 0.80%/year for Dabigatran 150 mg; 0.76%/year for Rivaroxaban and 0.74%/year for Apixaban instead of VKA. No significant differences were observed between the different NOACs and VKA in stroke rate. Major bleeding with acenocoumarol was 3.40%/year. The estimated rates for major bleeding using NOACs would be 2.75%/year for Dabigatran 150 mg; 3.37%/year for Rivaroxaban and 2.18%/year for Apixaban instead of VKA. Apixaban was the only NOAC that showed a significant estimated reduction rates (p=0.046). Finally, the all-cause mortality rate with acenocoumarol was 4.69%/year. The estimated rates of all-cause mortality using NOACs would be 3.28%/year for Dabigatran 150mg; 4.88%/year for Rivaroxaban and 2.67%/year for Apixaban. Dabigatran and Apixaban showed significant estimated reduction rates with the highest reduction with Apixaban (Table). Annual Rate reduction of adverse events Conclusion The absolute estimated effect of NOACs in the AF patients anticoagulated with VKA showed a significant reduction in adverse clinical events. Apixaban performed the highest estimated reduction in major bleeding and all-cause mortality in comparison with acenocoumarol.

P1255Comparative safety and effectiveness of standard doses of apixaban versus dabigatran, rivaroxaban, and VKAs in non-valvular atrial fibrillation patients in France: the NAXOS study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
N Danchin ◽  
P G Steg ◽  
O Hanon ◽  
I Mahe ◽  
M Belhassen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Lower Risk ◽  
Propensity Scores ◽  
Standard Dose ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Forest Plot ◽  
All Cause Mortality

Abstract Background Real-world data comparing all available oral anticoagulants (OAC) on a nationwide scale (i.e. in France: apixaban, rivaroxaban, dabigatran and vitamin K antagonists – VKAs) are lacking. In everyday practice, oral anticoagulants are often underdosed, which may render comparisons between agents difficult. Purpose and methods NAXOS is a French real-world study comparing the safety (major bleeding), effectiveness (stroke, systemic thromboembolic events (STE)) and all-cause mortality for apixaban, dabigatran, rivaroxaban, and VKAs, in adult patients with non-valvular atrial fibrillation (NVAF) initiating a given OAC between 2014 and 2016. The French national health insurance data (SNIIRAM) were used. Analyses were performed with adjustment on propensity scores. To avoid bias potentially related to underdosing, the present analysis included only patients receiving standard doses of apixaban (5mg bid), rivaroxaban (20mg od), and dabigatran (150 mg bid), or VKAs. Only OAC naïve patients were included. Results In the OAC-naive cohorts treated with apixaban, rivaroxaban, and dabigatran, 54,575 (62.3%), 65,208 (65.2%), and 9,000 (42.4%), respectively, had the standard dose at the index dispensation, and 112,628 patients received VKAs. After adjustment on propensity scores, apixaban 5 mg was associated with a lower risk of major bleeding, compared to VKAs (Hazard Ratio: 0.47; 95% CI: 0.43–0.51) and rivaroxaban 20mg (HR: 0.64; 0.59–0.71), but not to dabigatran 150 mg (HR: 0.97; 0.79–1.18). Apixaban was associated with a lower risk of stroke and STE, compared to VKAs (HR: 0.62; 0.56–0.69) but not to rivaroxaban (HR: 1.03; 0.92–1.16), and dabigatran (HR: 0.96; 0.76–1.21). Apixaban showed a lower risk of all-cause mortality compared to VKAs (HR: 0.44; 0.41–0.47) and rivaroxaban (HR: 0.87; 0.81–0.94) but not to dabigatran (HR: 1.10; 0.92–1.32). Figure 1. Forest plot presenting the results of the standard dose analysis (PS adjusted). Conclusions The NAXOS population-based country-wide observational study shows that 42% to 65% of patients were treated with standard doses of OACs. Analyses of standard doses confirmed the superiority of apixaban compared with VKAs for the three studied outcomes and suggests better safety profile of apixaban compared to rivaroxaban but similar to dabigatran. Acknowledgement/Funding The Alliance Bristol-Myers Squibb/Pfizer

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.

scholarly journals Non-vitamin K antagonist oral anticoagulants vs. vitamin-K antagonists in patients with atrial fibrillation and chronic kidney disease: a nationwide cohort study

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Emma Kirstine Laugesen ◽  
Laila Staerk ◽  
Nicholas Carlson ◽  
Anne-Lise Kamper ◽  
Jonas Bjerring Olesen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
All Cause Mortality ◽  
Comparable Population

Abstract Background We aimed to compare effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin-K antagonists (VKA) in atrial fibrillation (AF) patients with chronic kidney disease (CKD) not receiving dialysis. Methods By using personal identification numbers, we cross-linked individual-level data from Danish administrative registries. We identified every citizen with a prior diagnosis of AF and CKD who initiated NOAC or VKA (2011–2017). An external analysis of 727 AF patients with CKD (no dialysis) was performed to demonstrate level of kidney function in a comparable population. Study outcomes included incidents of stroke/thromboembolisms (TEs), major bleedings, myocardial infarctions (MIs), and all-cause mortality. We used Cox proportional hazards models to determine associations between oral anticoagulant treatment and outcomes. Results Of 1560 patients included, 1008 (64.6%) initiated VKA and 552 (35.4%) initiated NOAC. In a comparable population we found that 95.3% of the patients had an estimated glomerular filtration rate (eGFR) < 59 mL/min. Patients treated with NOAC had a significantly decreased risk of major bleeding (hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.26–0.84) compared to VKA. There was not found a significant association between type of anticoagulant and risk of stroke/TE (HR: 0.83, 95% CI: 0.39–1.78), MI (HR: 0.45, 95% CI: 0.18–1.11), or all-cause mortality (HR: 0.99, 95% CI: 0.77–1.26). Conclusion NOAC was associated with a lower risk of major bleeding in patients with AF and CKD compared to VKA. No difference was found in risk of stroke/TE, MI, and all-cause mortality.

scholarly journals Do EXCEL and NOBLE translate into real world? A 5-year observational study of left main stem outcomes

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001347
Author(s):  
George Joy ◽  
Hany Eissa
Keyword(s):  
Real World ◽  
Medical Management ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Major Adverse Cardiovascular Event ◽  
Coronary Intervention ◽  
Adverse Cardiovascular Event ◽  
Percutaneous Coronary ◽  
Significant Difference ◽  
All Cause Mortality

AimsWe aimed to uncover the 5-year real world outcomes of patients with significant left mainstem (LMS) disease managed with percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical management.MethodsWe identified patients with LMS disease in 2012 and analysed baseline characteristics and outcomes in the following 5 years.Results119 patients were identified, 62% (74) received CABG and 12% (14) received PCI and 26% (31) were medically managed. In PCI versus CABG, there was no significant difference in age and Synergy between PCI with Taxus and Cardiac Surgery score but there were significantly higher rates of pretreatment heart failure (ejection fraction 42%±10 vs 52%±13p=0.01). Overall major adverse cardiovascular event (MACE) being a composite of stroke, myocardial infarction (MI), target vessel revascularisation and all-cause mortality were not statistically different but numerically higher in the PCI group (36% (5) vs 23% (17) p=0.12). Medically managed patients were significantly older than those that were revascularised (PCI or CABG n=88; 75±11 vs 69±9 years p=0.01). They also had higher MACE (74% (23) vs 25% (22) p=0.000002) driven by MI (19% (6) vs 2% (1) p=0.01) and all-cause mortality (52% (16) vs 19% (17) p=0.01) compared with those with revascularisation.ConclusionsThe bleak outcomes of medical management in LMS disease are reflective findings from studies performed from several decades ago. Our findings show that there is still a role for PCI in the management of LMS disease in selected patients.

P4792Dabigatran versus vitamin K antagonists in patients with atrial fibrillation and valvular heart disease

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J E Strange ◽  
C Sindet-Pedersen ◽  
L Staerk ◽  
E L Grove ◽  
T A Gerds ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Heart Disease ◽  
Vitamin K ◽  
Valvular Heart Disease ◽  
Cox Regression ◽  
Absolute Risk ◽  
Risk Difference ◽  
Increased Risk ◽  
Significant Difference ◽  
All Cause Mortality

Abstract Background Atrial fibrillation (AF) and valvular heart disease (VHD) are both associated with an increased risk of stroke. Outside post-hoc analyses of randomized controlled trials, knowledge on the effectiveness and safety of dabigatran in patients with AF and VHD is scarce. Objectives To compare the risk of all-cause mortality, stroke, and bleeding in patients with AF and VHD treated with dabigatran or a vitamin K antagonist (VKA). Methods All Danish residents are provided a unique personal identification number enabling cross-linking of data from Danish nationwide registries. We identified all patients with AF and VHD initiating treatment with dabigatran or VKA between the 22nd of August 2011 and the 31st of December 2014. We defined VHD as aortic stenosis/regurgitation, mitral regurgitation, bioprosthetic heart valves, mitral-, and aortic valve repair. Outcomes were all-cause mortality, stroke, and bleeding. 2-year standardized absolute risks were calculated from cause-specific Cox regression models with death as competing risk. Results In total, 599 (27.3%) and 1,596 (72.7%) patients initiated treatment with dabigatran and VKA. The 2-year standardized absolute risk of all-cause mortality (95% CI) for VKA was 27.6% (25.1% to 30.1%) and 25.4% (21.8% to 29.0%) for dabigatran with a corresponding absolute risk difference of −2.2% (−6.3% to 1.9%) (Figure 1). The 2-year standardized absolute risk of stroke for VKA was 3.4% (2.3% to 4.5%) and 3.9% (2.2% to 5.5%) for dabigatran with a corresponding absolute risk difference of 0.5% (−1.6% to 2.5%). Lastly, the 2-year standardized absolute risk of bleeding for VKA was 8.2% (6.6% to 9.7%) and 7.6% (5.1% to 10.1%) for dabigatran with a corresponding absolute risk difference of −0.5% (−3.4% to 2.4%). Figure 1 Conclusions In this nationwide cohort study, we found no significant difference in the risk of all-cause mortality, stroke, or bleeding in patients with AF and VHD when comparing VKA to dabigatran.

Sepsis associated new onset atrial fibrillation; risk factors and long term outcomes

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Moosavi ◽  
M Paymard ◽  
R Ebrahimi ◽  
T Harvey ◽  
N Parkes ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Rate Control ◽  
Statistical Significance ◽  
Significant Difference ◽  
All Cause Mortality ◽  
New Onset

Abstract Background Atrial fibrillation (AF) is commonly encountered in the setting of systemic inflammation or infection. The optimal management of AF in this cohort and their long-term AF-related clinical outcome are unknown. Purpose The aims of our study were to evaluate the traditional and non-traditional AF risk factors and long-term AF-related clinical outcomes in patients who were diagnosed with new onset AF in the setting of sepsis. Methods In this retrospective cohort study, we used the medical records to identify patients who were diagnosed with the new onset AF during hospitalization for sepsis at our centre between 2013 and 2017. The primary clinical outcomes included 24-month risk of ischaemic stroke, major bleeding (gastrointestinal or intracranial bleeding), the recurrence of AF and the all-cause mortality. The patients with known AF or those who died during the index admission were excluded from the analysis. Results 5598 patients were admitted to our hospital between 2013 and 2017 with sepsis. Of this cohort, 126 patients (mean age 69.7 years, 62.7% male) developed new onset AF during the index hospital admission (72.2% required ICU admission). 38 patients (30.1%) died during the initial hospitalisation while 88 patients (69.9%) were discharged from hospital (32% anticoagulated). 14 patients (16%) died within 24 months. Hypertension (59%), CKD (30%), diabetes (21%), and CCF (17%) were the most common risk factors. Mean CHA2DS2VASC score was 2.56±1.4 and mean HAS BLED score was 2.5±1.3. Mean CRP and WCC were 228±119 and 12.3±9.1 respectively. Comparing risk factors, only HASBLED score showed statistical significance on 24 months mortality (p=0.036, 95% CI 0.43–1.52). The composite incidence of all-cause mortality and ischaemic stroke was three times lower in anticoagulated patients compared with those who did not receive anticoagulation even though this did not reach statistical significance (7.1% v 21.6% respectively, p=0.07; RR=0.32; 95% CI=0.79–1.36). There was no statistically significant difference between the two groups for major bleeding events (3.5% v 3.3% respectively, p=0.68; RR=1.07; 95% CI=0.10–11.3). Rhythm and rate control therapies showed no significant difference on the composite outcome of all-cause mortality, ischaemic stroke and recurrence of AF (28.0% v 28.9%, p=0.92; RR=0.96, 95% CI=0.49–1.88), however, there was a trend towards less recurrence of AF in patients who received rate or rhythm control therapies (12% vs 18% respectively p=0.44; RR=0.67; 95% CI=0.24–1.85). Conclusions Our study suggests that anticoagulation therapy in patients with sepsis associated new onset AF may decrease composite of all-cause mortality and ischaemic stroke without increasing major bleeding risk. Rhythm and rate control strategies did not decrease all-cause mortality, ischaemic stroke or risk of recurrence of AF. These findings can provide benchmarks for design of randomized control trials. Funding Acknowledgement Type of funding source: None

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