scholarly journals REAL-WORLD COMPARISON OF MAJOR BLEEDING RISK AMONG UNTREATED NON-VALVULAR ATRIAL FIBRILLATION PATIENTS AND THOSE INITIATING APIXABAN, DABIGATRAN, RIVAROXABAN, OR WARFARIN

2016 ◽  
Vol 67 (13) ◽  
pp. 668 ◽  
Author(s):  
Alpesh Amin ◽  
Allison Keshishian ◽  
Lin Xie ◽  
Onur Baser ◽  
Kwanza Price ◽  
...  
2016 ◽  
Vol 116 (11) ◽  
pp. 975-986 ◽  
Author(s):  
Allison Keshishian ◽  
Shital Kamble ◽  
Xianying Pan ◽  
Jack Mardekian ◽  
Ruslan Horblyuk ◽  
...  

SummaryIn addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in ‘real world’ clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013–31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012–31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39–0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50–0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83–1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36–2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Steven Deitelzweig ◽  
Amanda Bruno ◽  
Natalie Tate ◽  
Augustina Ogbonnaya ◽  
Manan Shah ◽  
...  

Real-world evidence highlighting the risks and benefits of novel oral anticoagulants (NOCAs) is lacking. This study compared major and clinically relevant non-major (CRNM) bleeding risk and costs among non-valvular atrial fibrillation (NVAF) patients newly treated with apixaban, dabigatran, rivaroxaban, or warfarin. A retrospective analysis of NVAF patients newly treated with apixaban, dabigatran, rivaroxaban, or warfarin was conducted using PharMetrics Plus data from 1/ 2012 - 9/ 2014. Patients were indexed on the date of the first anticoagulant prescription, and were required to be ≥18 years old and have CHA 2 DS 2 -VASc score > 0 and ≥ 1 month of follow-up. Patients were followed until discontinuation (≥30-day gap in treatment), treatment switch, end of continuous enrollment, 1 year post-index, or end of study. Major and CRNM bleeding, and bleeding-related costs were measured. Cox proportional hazards model was used to examine the association between anticoagulants and risk of bleeding and GLM was used to evaluate bleeding-related costs. The study included 24,573 NVAF patients; distributed as apixaban 11.7%, dabigatran 12.0%, rivaroxaban 36.7%, and warfarin 39.6%. Mean age was 64.4 and 66.5% were males. HAS-BLED and CHA 2 DS 2 -VASc scores averaged 2.0 and 2.7, respectively. After adjusting for differences in baseline characteristics, when compared to apixaban patients, rivaroxaban (HR: 1.5; P =0.0013) and warfarin (HR: 1.7; P <0.0001) patients were more likely to have major bleeding, and dabigatran (HR: 1.3; P =0.0030), rivaroxaban (HR: 1.7; P <0.0001), and warfarin (HR: 1.4; P <0.0001) patients were more likely to have CRNM bleeding. Major bleeding risk was similar between apixaban and dabigatran patients. Major and CRNM bleeding costs, when compared to apixaban patients ($154 and $18), were significantly higher for dabigatran ($457; P <0.0001 and $39; P <0.0001), rivaroxaban ($420; P <0.0001 and $61; P <0.0001), and warfarin ($511; P <0.0001 and $63; P <0.0001) patients. Among anticoagulant-naive moderate-to-high risk NVAF patients encountered in real-world clinical setting, major bleeding was lower with apixaban compared to warfarin and rivaroxaban. Bleeding costs were lower with apixaban compared to alternative NOACs and warfarin.


2017 ◽  
Vol 117 (10) ◽  
pp. 1848-1858 ◽  
Author(s):  
Vanessa Roldán ◽  
Vicente Vicente ◽  
Mariano Valdés ◽  
Gregory Y. H. Lip ◽  
María Asunción Esteve-Pastor ◽  
...  

SummaryRisk scores in patients with atrial fibrillation (AF) based on clinical factors alone generally have only modest predictive value for predicting high risk patients that sustain events. Biomarkers might be an attractive prognostic tool to improve bleeding risk prediction. The new ABCBleeding score performed better than HAS-BLED score in a clinical trial cohort but has not been externally validated. The aim of this study was to analyze the predictive performance of the ABC-Bleeding score compared to HAS-BLED score in an independent “real-world” anticoagulated AF patients with long-term follow-up. We enrolled 1,120 patients stable on vitamin K antagonist treatment. The HAS-BLED and ABC-Bleeding scores were quantified. Predictive values were compared by c-indexes, IDI, NRI, as well as decision curve analysis (DCA). Median HAS-BLED score was 2 (IQR 2–3) and median ABC-Bleeding was 16.5 (IQR 14.3–18.6). After 6.5 years of follow-up, 207 (2.84%/year) patients had major bleeding events, of which 65 (0.89%/year) had intracranial haemorrhage (ICH) and 85 (1.17%/year) had gastrointestinal bleeding events (GIB). The c-index of HAS-BLED was significantly higher than ABC-Bleeding for major bleeding (0.583 vs 0.518; p=0.025), GIB (0.596 vs 0.519; p=0.017) and for the composite of ICH-GIB (0.593 vs 0.527; p=0.030). NRI showed a significant negative reclassification for major bleeding and for the composite of ICH-GIB with the ABC-Bleeding score compared to HAS-BLED. Using DCAs, the use of HAS-BLED score gave an approximate net benefit of 4% over the ABC-Bleeding score. In conclusion, in the first “real-world” validation of the ABC-Bleeding score, HAS-BLED performed significantly better than the ABC-Bleeding score in predicting major bleeding, GIB and the composite of GIB and ICH.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.


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