scholarly journals Direct oral anticoagulants and the risk of osteoporotic fractures in patients with non-valvular atrial fibrillation

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110113
Author(s):  
Liang-Tseng Kuo ◽  
Su-Ju Lin ◽  
Victor Chien-Chia Wu ◽  
Jung-Jung Chang ◽  
Pao-Hsien Chu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Hip Fracture ◽  
Osteoporotic Fracture ◽  
Low Dose ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Osteoporotic Fractures ◽  
Different Types ◽  
History Of ◽  
Artery Disease

Background: The incidence of osteoporotic fracture increases with age, particularly in elderly populations with atrial fibrillation (AF). However, direct oral anticoagulants (DOACs) have less effect on osteoporotic fracture than vitamin K antagonists, it is unclear whether the risk of osteoporotic fracture is affected by different types and doses of DOACs in AF patients. Methods: This nationwide population-based cohort study included AF patients prescribed DOACs between 2011 and 2016 taken from the Taiwan National Health Insurance database. Adjusted hazard ratios (aHRs) for the risk of osteoporotic, hip, and spine fractures between DOAC users were compared using the Fine and Gray subdistribution hazard model to adjust for possible confounders. Results: A total of 56,795 patients who were prescribed DOACs were included in the present study. Among them, 24,597 patients received dabigatran, 26,968 received rivaroxaban, and 5230 received apixaban. After 2 years’ follow up, there was no significant difference in the incidence of osteoporotic, spine, or hip fracture among those receiving dabigatran, rivaroxaban, or apixaban. Subgroup analysis showed that patients taking dabigatran had a higher incidence of osteoporotic and hip fracture than those taking rivaroxaban and apixaban in cases with concomitant peripheral artery disease (PAD) or a history of hip fracture ( p for interaction: 0.004 and 0.030, respectively). However, dabigatran users had a lower incidence of osteoporotic fracture and spine fracture in those receiving standard-dose DOACs compared with rivaroxaban and apixaban; whereas, they had a higher incidence of hip fractures when administered at low dose. Conclusion: AF patients with different DOACs did not have different risks of osteoporotic fracture overall. However, additional concomitant morbidities, such as PAD or a history of hip fracture, and standard/low doses might be associated with different risks for different DOACs. These findings should be taken into consideration in the clinic when the DOAC is being chosen. Plain language summary Different direct oral anticoagulants had different impact on osteoporotic fracture Anticoagulation therapy is an essential therapy in atrial fibrillation (AF) patients, but osteoporotic fracture is another important issue in these patients prescribed with anticoagulants. However, no study has been conducted to evaluate the impact of different DOACs on different types of osteoporotic fractures. In our findings, although different DOACs had no significantly different impact on osteoporotic fractures, dabigatran users had a slightly higher incidence of osteoporotic and hip fractures among different DOACs, particularly in those have simultaneously had peripheral artery disease, a history of hip fracture. In addition, when AF patients taking low-dose DOACs, dabigatran users also have higher incidence of hip fracture than those taking other DOACs.

scholarly journals The Role of Direct Oral Anticoagulants in Patients With Coronary Artery Disease

2018 ◽  
Vol 24 (2) ◽  
pp. 103-112 ◽  
Author(s):  
Ricky D. Turgeon ◽  
Margaret L. Ackman ◽  
Hazal E. Babadagli ◽  
Jade E. Basaraba ◽  
June W. Chen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Triple Therapy ◽  
Antiplatelet Therapy ◽  
Low Dose ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Artery Disease ◽  
Stable Cad

Despite contemporary management, patients with coronary artery disease (CAD) remain at high risk for thrombotic events. Several randomized controlled trials have evaluated the use of direct oral anticoagulants (DOACs) in patients with CAD, including in the setting of acute coronary syndrome (ACS) and stable CAD, and in patients with concomitant atrial fibrillation. Trials of apixaban and dabigatran in patients with ACS demonstrate no benefit with an increased risk of bleeding. Conversely, rivaroxaban at a reduced dose of 2.5 mg twice daily reduced thrombotic events and all-cause mortality when added to dual antiplatelet therapy in patients with ACS. Similarly, the addition of low-dose rivaroxaban to acetylsalicylic acid reduced the risk of thrombotic events in patients with stable CAD. However, the addition of a DOAC to antiplatelet therapy increased the risk of major bleeding. In patients with atrial fibrillation undergoing percutaneous coronary intervention, dual-pathway or low-dose triple therapy regimens including dabigatran or rivaroxaban reduced bleeding risk compared to traditional warfarin-based triple therapy, although it remains unclear whether these regimens preserve antithrombotic efficacy. DOAC–based antithrombotic regimens prove useful in patients with CAD in various settings; however, careful selection of patients and regimens per trial protocols are critical to achieving net benefit.

P6248High use of direct oral anticoagulants in elderly patients with non valvular atrial fibrillation: results of REFLEJA study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Torres Llergo ◽  
M R Fernandez Olmo ◽  
M Carrillo Bailen ◽  
M Puentes Chiachio ◽  
M Martin Toro ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Older Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
P Value ◽  
Hemorrhagic Risk ◽  
Independent Risk Factors ◽  
Artery Disease ◽  
Anticoagulated Patients ◽  
Antiarrhythmic Treatment

Abstract Background Older patients with atrial fibrillation (AF) have a higher thromboembolic and hemorrhagic risk, however oral anticoagulation (OAC) continues to be underutilized. Purpose To analyze the use of direct oral anticoagulant (DOAC) in patients older than 80 years. Methods The REFLEJA study is a single-centre prospective observational registry including 1039 consecutive outpatients with nonvalvular AF. Results Among ≥80 years patients (n=376) there were more women (57.7% vs 41.5%; p<0.001), permanent AF (66.5 vs 42%; <0.001), heart failure (HF) (29.8 vs 20.2%, p<0.001) and vascular disease (19.7 vs 12.8%, p=0.003), although without differences in bleeding (5.9 vs 3,8%, p=0.12) and previous strokes (9.3 vs 7.1%, p=0.20). Despite a higher CHA2DS2-VASc score (4.4±1.1 VS 2.9±1.6, p<0.001), HASBLED score >2 (34.6 vs. 23.7%; p<0.001) and chronic kidney disease (CKD) (51.5 vs. 22.6%, p<0.001), total use of OAC was higher among those older (94.9% vs 90%, p=0.005). There were no differences in the prescription of DOAC (64.1% vs 69.3%, p=0.08), although lower doses (45.8 vs. 12.2%, p<0.005) were more frecuent among older patients. In multivariate analysis, HF (OR 0.60, CI 0.40–0.90; p=0.013) and CKD (OR 0.55, CI 0.41–0.76; p<0.001) were independent risk factors for the prescription of DOAC, but not age ≥80 years (OR 1.16, CI 0.58–2.31, P=0.67). Baseline characteristics Total <80 years ≥80 years p value Hypertension (%) 81.5 77.9 88 <0.001 Diabetes mellitus (%) 26.3 25.7 26.7 0.71 Malignancy (%) 6.6 6.5 6.9 0.78 Coronary artery disease (%) 12.1 10.8 14.4 0.08 Anemia (%) 16.3 12.5 23.2 <0.001 DOAC (%) 67.6 69.3 64.1 0.08 Low doses DOAC (%) 15.9 12.2 45.8 <0.001 CHA2DS2-VASc score 3.4±1.6 2.9±1.6 4.4±1.1 <0.001 HAS-BLED score 1.2±0.8 1.1±0.8 1.4±0.7 <0.001 Glomerular filtration rate (ml/min) 70.9±24.9 76.2±23.1 61.5±25 <0.001 Antiarrhythmic treatment (%) 7.3 9.6 3.1 0.005 Permanent AF 50.5 41.7 66.2 <0.001 DOAC: direct oral anticoagulants; HAS-BLED score: without INR lability; AF: atrial fibrillation. Conclusion The proportion of elderly anticoagulated patients in our environment is very high and advanced age was not associated with a lower use of DOAC.

scholarly journals Effectiveness and Safety of Direct Oral Anticoagulant for Secondary Prevention in Asians with Atrial Fibrillation

2019 ◽  
Vol 8 (12) ◽  
pp. 2228 ◽  
Author(s):  
Jiesuck Park ◽  
So-Ryoung Lee ◽  
Eue-Keun Choi ◽  
Soonil Kwon ◽  
Jin-Hyung Jung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Secondary Prevention ◽  
Major Bleeding ◽  
Recurrent Stroke ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Composite Outcome ◽  
Improved Outcomes ◽  
History Of ◽  
Cumulative Risks

We investigated the effectiveness and safety of direct oral anticoagulants (DOACs) for secondary prevention in patients with atrial fibrillation (AF), particularly focusing on subgroups of patients with severe, disabling, and recent stroke. Using the Korean National Health Insurance Service claims database between January 2010 and April 2018, we selected OAC-naïve patients with non-valvular AF and a history of stroke. Cumulative risks for recurrent stroke, major bleeding, composite outcome (recurrent stroke + major bleeding), and mortality were compared between DOAC and warfarin groups. Among 61,568 patients, 28,839 and 32,729 received warfarin and DOACs, respectively. Compared with warfarin, DOACs were associated with lower risks of recurrent stroke (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.62–0.72), major bleeding (HR 0.73, 95% CI 0.66–0.80), composite outcome (HR 0.69, 95% CI 0.65–0.73), and mortality. DOAC use resulted in a consistent trend of improved outcomes in the subgroups of patients with severe, disabling, and recent stroke. In conclusion, DOACs were associated with lower risks of recurrent stroke, major bleeding, composite clinical outcomes, and mortality in patients with AF and a history of stroke. These results were consistent across all types of DOACs and subgroups of patients with severe, disabling, and recent stroke.

scholarly journals Comparative Effectiveness and Safety of Low-Dose Oral Anticoagulants in Patients With Atrial Fibrillation

2022 ◽  
Vol 12 ◽  
Author(s):  
Sylvie Perreault ◽  
Alice Dragomir ◽  
Robert Côté ◽  
Aurélie Lenglet ◽  
Simon de Denus ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Comparative Effectiveness ◽  
Lower Risk ◽  
Low Dose ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Significant Risk ◽  
Population Based ◽  
Pharmacokinetic Data ◽  
Effectiveness Endpoint

Aims: Observational studies of various dose levels of direct oral anticoagulants (DOACs) for patients with atrial fibrillation (AF) found that a high proportion of patients received a dose lower than the target dose tested in randomized controlled trials. There is a need to compare low-dose DOACs with warfarin or other DOACs on effectiveness and safety.Methods: Using administrative data from Quebec province, Canada, we built a cohort of new warfarin or DOAC users discharged from hospital between 2011 and 2017. We determined CHA2DS2-VASc and HAS-BLED scores, and comorbidities for 3-year prior cohort entry. The primary effectiveness endpoint was a composite of ischemic stroke/systemic embolism (SE), and secondary outcomes included a safety composite of major bleeding (MB) events and effectiveness composite (stroke/SE, death) at 1-year follow-up. We contrasted each low-dose DOAC with warfarin or other DOACs as references using inverse probability of treatment weighting to estimate marginal Cox hazard ratios (HRs).Results: The cohort comprised 22,969 patients (mean age: 80–86). We did not find a significant risk reduction for the stroke/SE primary effectiveness endpoint for DOACs vs. warfarin; however, we observed a significantly lower risk for low-dose dabigatran vs. warfarin (HR [95%CI]: 0.59 [0.42–0.81]) for effectiveness composite, mainly due to a lower death rate. The differences in effectiveness and safety composites between low-dose rivaroxaban vs. warfarin were not significant. However, low-dose apixaban had a better safety composite (HR: 0.68 [0.53–0.88]) vs. warfarin. Comparisons of dabigatran vs. apixaban showed a lower risk of stroke/SE (HR: 0.53 [0.30–0.93]) and a 2-fold higher risk of MB. The MB risk was higher for rivaroxaban than for apixaban (HR: 1.58 [1.09–2.29]).Conclusions: The results of this population-based study suggest that low-dose dabigatran has a better effective composite than warfarin. Compared with apixaban, low-dose dabigatran had a better effectiveness composite but a worse safety profile. Low-dose apixaban had a better safety composite than warfarin and other low-dose DOACs. Given that the comparative effectiveness and safety seem to vary from one DOAC to another, pharmacokinetic data for specific populations are now warranted.

scholarly journals Safety of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials

2021 ◽  
Author(s):  
Katharina Doni ◽  
Stefanie Bühn ◽  
Alina Weise ◽  
Nina-Kristin Mann ◽  
Simone Hess ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Older Adults ◽  
Low Dose ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
High Dose ◽  
Meta Analyses

Abstract PurposeOur objective was to assess the safety of long-term intake of DOACs in older adults with atrial fibrillation (AF). MethodsWe included RCTs in elderly (≥65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 9/11/2020. For determination of risk of bias, the RoB-2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE.ResultsTen RCTs with a total of 61,948 patients were identified. Seven RCTs included patients with AF-only and three with AF who received PCI and additional antiplatelet-therapy. Two RCTs compared apixaban with either warfarin or aspirin, three edoxaban with either placebo, aspirin, or Vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF-only (HR 0.89 95%CI 0.78 to 1.02). We did not find any RCT that reported mortality in elderly AF-PCI patients. Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). High-dose edoxaban reduces major or clinically relevant bleeding (MCRB) compared to VKAs (HR 0.82 95%CI 0.73 to 0.93) but high-dose dabigatran or rivaroxaban increase MCRB (HR 1.15 95%CI 1.02 to 1.30).Conclusion We found that low-dose DOACs probably decrease mortality in AF-only patients. Moreover, apixaban and edoxaban are associated with fewer MCRB compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose.

scholarly journals Outcomes of Direct Oral Anticoagulants with Aspirin Versus Warfarin with Aspirin for Atrial Fibrillation and/or Venous Thromboembolic Disease

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 179-179
Author(s):  
Jordan K Schaefer ◽  
Josh Errickson ◽  
Xiaowen Kong ◽  
Tina Alexandris-Souphis ◽  
Mona A Ali ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Research Funding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Thromboembolic Disease ◽  
Venous Thromboembolic Disease ◽  
Advisory Committees ◽  
Venous Thromboembolic ◽  
History Of

Abstract Introduction The direct oral anticoagulants (DOACs) including apixaban, dabigatran, edoxaban, and rivaroxaban are increasingly utilized for the management of venous thromboembolic disease (VTE) and/or non-valvular atrial fibrillation (NVAF). Adding aspirin (ASA) to warfarin or DOAC therapy increases bleeding risk. Patients on combination therapy with ASA and an anticoagulant were not well represented in clinical trials comparing DOACs to warfarin. We sought to compare bleeding and thrombotic outcomes with DOACs and ASA compared to warfarin and ASA in a non-trial setting. Methods We conducted a retrospective registry-based cohort study of adults on DOAC or warfarin therapy for VTE and/or NVAF. Warfarin treated patients were followed by six anticoagulation clinics. Four out of the six clinics contributed data on their patients that were on DOACs in the Michigan Anticoagulation Quality Improvement Initiative (MAQI 2) from January 2009 to June 2021. Patients were excluded if they had a history of heart valve replacement, recent myocardial infarction, or less than 3 months of follow-up. Two propensity matched cohorts (warfarin+ASA vs DOAC+ASA) of patients were analyzed based on ASA use at the time of study enrollment. The primary outcome was any new bleeding event. Secondary outcomes included new episodes of arterial or venous thrombosis, bleeding event type (major, fatal, life threatening, central nervous system, and non-major bleeding), emergency room visits, hospitalizations, transfusions, and death. Random chart audits were done to confirm the accuracy of the abstracted data. Event rates were compared using Poisson regression. Results We identified a total of 1,139 patients on DOACs plus ASA and 4,422 patients on warfarin plus ASA. After propensity matching, we compared two groups of 1,114 matched patients. DOAC treated patients were predominately on apixaban (62.3%) and rivaroxaban (30.4%), most often at therapeutic doses (Table 1). Patients were largely (90.5%) on low dose ASA (≤ 100 mg). Patient demographics, co-morbidities, indication for anticoagulation, history of bleeding or clotting, medications, and duration of follow-up were well-balanced after matching. Patients were followed for a median of 11.7 months (interquartile range 4.4 and 34 months). Patients treated with DOAC+ASA had 2.4 thrombotic events per 100 patient years compared to 2.2 thrombotic events per 100 patient years with warfarin+ASA (P=0.78). There were no significant differences observed between groups by thrombotic subtype (stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis, table 1). Bleeding was also similar with 30.1 bleeding events per 100 patient years with DOAC+ASA compared to 27.8 bleeds per 100 patient years with warfarin+ASA (P=0.24). There were no significant differences by bleeding subtype (table 1). Hospitalizations for clotting occurred less frequently with DOAC+ASA (0.9 hospitalizations per 100 patient years) compared to warfarin+ASA (1.7 hospitalizations per 100 patient years, P=0.03). Mortality, transfusions, and healthcare utilization were otherwise similar between the two groups. Conclusions For patients on a DOAC versus warfarin with ASA for atrial fibrillation and/or venous thromboembolic disease without a recent myocardial infarction or heart valve replacement, bleeding and thrombotic outcomes were similar. Figure 1 Figure 1. Disclosures Kaatz: Gilead: Consultancy; CSL Behring: Consultancy; Novartis: Consultancy; Bristol Myer Squibb: Consultancy, Research Funding; Pfizer: Consultancy; Alexion: Consultancy; Janssen: Consultancy, Research Funding; Osmosis Research: Research Funding. Kline-Rogers: Janssen: Consultancy; American College of Physicians: Consultancy. Sood: Bayer: Consultancy. Froehlich: Merck: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Boehringer-Ingelheim: Consultancy; Pfizer: Consultancy; Blue Cross Blue Shield of Michigan: Research Funding; Fibromuscular Disease Society of America: Research Funding. Barnes: National Certification Board of Anticoagulation Providers: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; Acelis: Consultancy; AMAG Pharmaceuticals: Consultancy; Connected Health: Consultancy; Blue Cross Blue Shield of Michigan: Research Funding; AC Forum: Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy; Bristol-Myers Squibb: Consultancy.

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