Estimation of the impact of warfarin’s time-in-therapeutic range on stroke and major bleeding rates and its influence on the medical cost avoidance associated with novel oral anticoagulant use-learnings from ARISTOTLE, ROCKET-AF, and RE-LY trials

2014 ◽  
Vol 38 (2) ◽  
pp. 150-159 ◽  
Author(s):  
Alpesh Amin ◽  
Steve Deitelzweig ◽  
Yonghua Jing ◽  
Dinara Makenbaeva ◽  
Daniel Wiederkehr ◽  
...  
Keyword(s):  
Therapeutic Range ◽  
Major Bleeding ◽  
Medical Cost ◽  
Oral Anticoagulant ◽  
Cost Avoidance ◽  
Time In Therapeutic Range ◽  
Novel Oral Anticoagulant ◽  
The Impact

Impact of liver disease on oral anticoagulant prescription and major adverse events in patients with atrial fibrillation: analysis from a population-based cohort study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
I Marzona ◽  
T Vannini ◽  
P Colacioppo ◽  
M Tettamanti ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Liver Disease ◽  
Risk Ratio ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Population Based ◽  
Primary Study ◽  
Secondary Bleeding ◽  
The Impact

Abstract Aims Data on the impact of liver disease (LD) in patients with atrial fibrillation (AF) and the role of oral anticoagulant (OAC) drugs for stroke prevention, are limited. We analysed the impact of LD and OAC treatment in determining stroke, major bleeding, all-cause death and secondary bleeding outcomes. Methods A retrospective observational population-based cohort study. The study cohort is derived from the administrative health databases of Lombardy region (>10 million inhabitants), Italy. All AF patients ≥40 years admitted to hospital from 2000 to 2018 were considered. AF and LD diagnosis were established using ICD9-CM codes. Use of OAC was determined with Anatomical Therapeutic Chemical (ATC) codes. Primary study outcomes were stroke, major bleeding and all-cause death. Results Among 393,507 AF patients, 16,168 (4.1%) had concomitant LD. LD AF patients were significantly less treated with OAC independent of associated clinical characteristics (OR: 0.96, 95% CI: 0.92–0.98). Concomitant LD was found associated with an increased risk in all the study outcomes (HR: 1.18, 95% CI: 1.11–1.25 for stroke; HR: 1.57, 95% CI: 1.47–1.66 for major bleeding; HR: 1.41, 95% CI: 1.39–1.44 for all-cause death. Use of OAC in patients with AF and LD resulted in a reduction in stroke (HR: 0.80, 95% CI: 0.70–0.92), major bleeding (HR: 0.86, 95% CI: 0.74–0.99) and all-cause death (HR: 0.85, 95% CI: 0.80–0.90), with similar results according to several clinically relevant subgroups. A net clinical benefit (NCB) analysis suggested a positive benefit/risk ratio in using OAC in AF patients with LD (NCB: 0.408, 95% CI: 0.375–0.472). Conclusions In AF patients, concomitant LD carries a significantly higher risk for all clinical outcomes. Use of OAC in AF patients with LD was associated with a significant benefit/risk ratio, even in high-risk patient subgroups. Funding Acknowledgement Type of funding source: None

scholarly journals Poor Time in Therapeutic Range Control is Associated with Adverse Clinical Outcomes in Patients with Non-Valvular Atrial Fibrillation: A Report from the Nationwide COOL-AF Registry

2020 ◽  
Vol 9 (6) ◽  
pp. 1698 ◽  
Author(s):  
Rungroj Krittayaphong ◽  
Thoranis Chantrarat ◽  
Roj Rojjarekampai ◽  
Pongpun Jittham ◽  
Poom Sairat ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Clinical Outcomes ◽  
Therapeutic Range ◽  
Major Bleeding ◽  
Stroke Prevention ◽  
International Normalized Ratio ◽  
Time In Therapeutic Range ◽  
Hazard Ratios ◽  
The Relationship

Background: Warfarin remains the most commonly used oral anticoagulant (OAC) in Thailand for stroke prevention among patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to investigate the relationship between time in therapeutic range (TTR) after warfarin initiation and clinical outcomes of NVAF. Methods: TTR was calculated by the Rosendaal method from international normalized ratio (INR) data acquired from a nationwide NVAF registry in Thailand. Patients were followed-up every six months. The association between TTR and clinical outcomes was analyzed. Results: There was a total of 2233 patients from 27 hospitals. The average age was 68.4 ± 10.6 years. The average TTR was 53.56 ± 26.37%. Rates of ischemic stroke/TIA, major bleeding, ICH, and death were 1.33, 2.48, 0.76, and 3.3 per 100 person-years, respectively. When patients with a TTR < 65% were compared with those with TTR ≥ 65%, the adjusted hazard ratios (aHR) for the increased risks of ischemic stroke/TIA, major bleeding, ICH, and death were 3.07, 1.90, 2.34, and 2.11, respectively. Conclusion: Poor TTR control is associated with adverse clinical outcomes in patients with NVAF who were on warfarin. Efforts to ensure good TTR (≥65%) after initiation of warfarin are mandatory to minimize the risk of adverse clinical outcomes.

THE IMPACT OF TEMPORARY INTERRUPTIONS OF WARFARIN ON DOWNSTREAM TIME IN THERAPEUTIC RANGE IN PATIENTS WITH ATRIAL FIBRILLATION: RESULTS FROM ORBIT AF

2019 ◽  
Vol 73 (9) ◽  
pp. 468
Author(s):  
Malini Madhavan ◽  
DaJuanicia N. Holmes ◽  
Jonathan Piccini ◽  
James Freeman ◽  
Gregg Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Therapeutic Range ◽  
Time In Therapeutic Range ◽  
The Impact

Venous Thromboembolism in Lymphoma: How Effectively Are We Treating Patients?.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1878-1878
Author(s):  
Alaa A. Muslimani ◽  
Timothy P. Spiro ◽  
Asif A. Chaudhry ◽  
Hamed A. Daw
Keyword(s):  
Pulmonary Embolism ◽  
Retrospective Study ◽  
Therapeutic Range ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Minor Bleeding ◽  
Anticoagulant Treatment ◽  
Recurrent Thrombosis ◽  
Oral Anticoagulant Treatment ◽  
Recurrent Vte

Abstract Introduction: Patients (pts) with solid tumors and venous thromboembolic episodes (VTE) have a high risk of complications (recurrent VTE/bleeding) during oral anticoagulant treatment. However, few data are available in pts with lymphoma. We conducted a retrospective study to determine the frequency of complications during oral anticoagulant treatment in lymphoma pts. Methods: Charts of histologically proven non-Hodgkin’s (NHL) and Hodgkin lymphoma (HL) pts at our institution from January 1998 through April 2007 were retrospectively reviewed. After excluding pts with thrombocytosis, solid tumors, hypercoagulability or previous treatment with anticoagulants, pts with their first acute symptomatic VTE were identified (49 NHL, 8 HL). 31 were males and 26 females, with an age range of 40–89 years. The first symptomatic VTE was defined as lymphoma associated if the VTE occurred within 3 months before or after the biopsy diagnosis of the lymphoma but before chemotherapy. These VTE were confirmed by contrast venography or doppler ultrasound for venous thrombosis (neck and upper-lower extremities) and chest computed tomography, ventilation/perfusion scan, or pulmonary angiography for pulmonary embolism. Major bleeding was defined as bleeding that required transfusion, caused a drop of hemoglobin &gt; 2 g/dL, or occurred in critical sites. Minor bleeding was defined as any overt bleeding that required stopping the anticoagulant treatment but not fulfilling the definition of major bleeding. Results: All 57 pts were initially treated with high dose adjusted intravenous heparin or body weight adjusted low molecular weight heparin (LMWH). 46 pts were started on oral warfarin during the first 10 days of the initial treatment witch was continued for at least 3 months after discontinuing heparin. 11 pts received continuing LMWH and no warfarin. Recurrent VTE occurred in 14/46 pts on warfarin therapy. The international normalized ratio (INR) was within the therapeutic range (2.0–3.0) in 10/14 pts, and below the therapeutic INR (&lt; 2.0) in 4/14 pts. Death was directly correlated to recurrent VTE (massive pulmonary embolism) in 2 pts in the warfarin treated group; a third death was caused by massive intracranial bleeding. Major bleeding was documented in 6/46 pts (4 pts had an INR within the therapeutic range, 2 had INR &gt; 3), and minor bleeding in 9/46 pts. Recurrent VTE occurred in 1/11 pts treated with LMWH, major bleeding in 0/11 and minor bleeding in 3/11 pts with no deaths. Conclusions: Previous studies showed an overall incidence of 27.1% recurrent thrombosis and 5.4% major bleeding in pts with malignancy treated with oral anticoagulant for VTE. Our study showed 30.4% recurrent thrombosis and 13% major bleeding in pts with lymphoma. Most bleeding and thrombotic complications occurred with an INR within the therapeutic range (65%). The percentage of serious complications was very high during the use of warfarin (43.5%), and the death rate 6.5%, compared to 9% and 0% during the use of LMWH. A high failure rate of oral anticoagulant treatment in pts with lymphoma suggests the need for alternative treatment. Since the number of pts in this retrospective study is small, a prospective randomized, controlled study comparing warfarin with LMWH is indicated.

Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial

2021 ◽  
pp. 1-7
Author(s):  
Wern Yew Ding ◽  
Gregory Y.H. Lip ◽  
Alena Shantsila
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Therapeutic Range ◽  
Major Bleeding ◽  
Post Hoc Analysis ◽  
Time In Therapeutic Range ◽  
All Cause Mortality ◽  
Post Hoc ◽  
Moderate Renal Failure

<b><i>Background:</i></b> The benefit of anticoagulation therapy in atrial fibrillation (AF) and chronic kidney disease (CKD) remains controversial. We aimed to evaluate the impact of renal function on the quality of anticoagulation control, and the effects of both these factors on outcomes in AF. <b><i>Methods:</i></b> Post hoc analysis of the AMADEUS trial. Trial-related outcomes were adjudicated and we studied the composite of first stroke/major bleeding/all-cause mortality, ischaemic stroke, major bleeding, all-cause mortality, and cardiovascular mortality. <b><i>Results:</i></b> We included 2,282 vitamin K antagonist (VKA)-treated patients {<i>n</i> = 787 (34.5%) females; median age 72 (interquartile ranges [IQR] 64–77) years}. Median follow-up was 365 (IQR 189–460) days. There were 1,922 (84.2%) non-CKD and 360 (15.8%) CKD patients. Renal function was inversely correlated with time-in-therapeutic range (<i>r</i> = −0.047, <i>p</i> = 0.025). There was no statistical difference in terms of crude study outcomes based on renal function. Multivariable regression analysis demonstrated that moderate renal failure with estimated glomerular filtration rate of less than 60 mL/min/1.73 m<sup>2</sup> (<i>p</i> = 0.032) and percentage of time-in-therapeutic range (<i>p</i> = 0.011) were independent predictors for the composite outcome of stroke, major bleeding, and all-cause mortality. <b><i>Conclusion:</i></b> Deteriorated renal function has a small negative impact on the quality of anticoagulation control with VKA which is linked to poor outcomes in AF. However, moderate renal failure itself was an independent risk factor for increased risk of stroke, major bleeding, and all-cause mortality amongst patients with AF.

Abstract 249: Medical Cost Avoidance among the General and Elderly Atrial Fibrillation Populations Differs According to Specific Anticoagulant Use, Based on the ARISTOTLE and RE-LY Trials

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Alpesh Amin ◽  
Steve Deitelzweig ◽  
Yonghua Jing ◽  
Dinara Makenbaeva ◽  
Daniel Wiederkehr ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
General Population ◽  
Major Bleeding ◽  
Medical Cost ◽  
Elderly Population ◽  
The Elderly ◽  
Medical Costs ◽  
Cost Avoidance ◽  
Weighted Averages ◽  
Event Rates

Introduction: The randomized ARISTOTLE and RE-LY clinical trials demonstrated that the new oral anticoagulants (NOACs) apixaban and dabigatran were effective and safe options for stroke prevention among non-valvular atrial fibrillation (AF) patients. It is unclear how the use of NOACs for the treatment of AF affects total medical costs. Hypothesis: This study evaluates the hypothesis that medical costs associated with the use of apixaban and dabigatran vs. warfarin are different among the general and elderly AF populations. Methods: Clinical event rates in patients receiving warfarin, apixaban, and dabigatran were estimated for the general and elderly (age ≥ 75 years) AF patient populations. Event rates associated with warfarin were calculated as weighted averages from NOAC trials among AF patients; NOAC rates were estimated by adjusting trial hazard ratios to these weighted averages. Annual incremental costs among patients with clinical events from the US payer perspective were obtained from published literature and inflation adjusted to 2010 cost levels. Medical cost avoidance was evaluated for each NOAC vs. warfarin. Results: Compared to warfarin, apixaban-mediated total medical cost reductions (Table) in both populations were driven by decreased major bleeding excluding hemorrhagic stroke (MBEHS) and stroke and systemic embolism (SSE). Dabigatran use reduced costs for the general population and increased costs for the elderly population; cost reduction in the general population was primarily due to reduced SSE while cost increase in the elderly population was primarily due to increased MBEHS. MI, PE or DVT, and non-major bleeding each made smaller contributions to the cost differences among both populations. Conclusions: Compared to warfarin, apixaban use may be associated with reduced medical costs in both general and elderly AF populations. Dabigatran use may be associated with a reduction of medical costs in the general AF population, but increased medical costs among the elderly.

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