Comparison of Dabigatran and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease

Ezekowitz, Michael D.; Nagarakanti, Rangadham; Noack, Herbert; Brueckmann, Martina; Litherland, Claire; Jacobs, Mark; Clemens, Andreas; Reilly, Paul; Connolly, Stuart J.; Yusuf, Salim; Wallentin, Lars

doi:10.1161/circulationaha.115.020950

Cited by 141 publications

(70 citation statements)

References 13 publications

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“…Previous post hoc analyses of patients with VHD included in the pivotal NOAC trials showed increased stroke and major bleeding risk among patients with VHD, similar to our study findings 8, 9, 10. The relative benefits of NOACs were comparable in patients with and without VHD, despite higher thromboembolic and bleeding risk in the VHD cohorts.…”

Section: Discussionsupporting

confidence: 90%

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Briasoulis

Inampudi

Akintoye

et al. 2018

JAHA

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BackgroundWe examined a large community‐based sample of patients with atrial fibrillation (AF) and valvular heart disease (VHD) (excluding prosthetic valves) with a goal to compare outcomes among patients with AF, with and without VHD, taking warfarin, dabigatran, and rivaroxaban.Methods and ResultsWe identified Medicare beneficiaries enrolled in Medicare Part D benefit plan from 2011 to 2013 with newly diagnosed AF (18 137 patients with VHD [dabigatran, 1979; rivaroxaban, 2027; warfarin, 14 131] and 85 596 patients without VHD [dabigatran, 13 522; rivaroxaban, 14 257; warfarin, 57 817]). Primary outcomes of all‐cause mortality, ischemic strokes, major bleeding, and myocardial infarction were compared across the 3 anticoagulants using 3‐way propensity‐matched samples. After propensity matching, a total of 5871 patients with VHD and 40 221 patients without VHD and AF were studied. Both dabigatran and rivaroxaban were associated with significantly lower risk of death in patients with VHD with AF (dabigatran versus warfarin: hazard ratio, 0.71; 95% confidence interval, 0.52–0.98; P=0.038; rivaroxaban versus warfarin: hazard ratio, 0.68; 95% confidence interval, 0.49–0.95; P=0.022). Nongastrointestinal bleeding was significantly reduced with dabigatran and rivaroxaban versus warfarin in those with VHD (dabigatran versus warfarin: hazard ratio, 0.17; 95% confidence interval, 0.06–0.49; P=0.001; rivaroxaban versus warfarin: hazard ratio, 0.37; 95% confidence interval, 0.17–0.84; P=0.017). Ischemic stroke and gastrointestinal bleeding rates did not differ between rivaroxaban, dabigatran, and warfarin in patients with VHD. The effects of the 3 anticoagulants on outcomes were comparable in patients with and without VHD and with AF.ConclusionsIn this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new‐onset AF between 2011 and 2013, novel oral non–vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism.

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Section: Discussionsupporting

confidence: 90%

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Briasoulis

Inampudi

Akintoye

et al. 2018

JAHA

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“…However, we used a broader definition in this study because the severity of valvular disease was not well documented in the EMRs, and we were collecting data from as far back as 2010, when older definitions of valvular AF were in place. Moreover, in light of emerging evidence that patients with nonprosthetic valvular AF may still derive benefits from these agents,10 we felt that DOACs may not necessarily be inappropriate in these cases. The second caveat with our findings is that we did not classify a DOAC prescription for the 9% of patients with CHADS scores of 0 as inappropriate, although some guidelines would,11, 12 because we did not know if those patients had cardioversions planned, and we were not privy to the discussions between clinicians and patients about their values and preferences with respect to stroke prevention versus bleeding risk.…”

Section: Discussionmentioning

confidence: 99%

Use of Direct Oral Anticoagulants in Canadian Primary Care Practice 2010–2015: A Cohort Study From the Canadian Primary Care Sentinel Surveillance Network

McAlister

Garrison

Kosowan

et al. 2018

JAHA

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BackgroundAs questions have been raised about the appropriateness of direct oral anticoagulant (DOAC) dosing among outpatients with atrial fibrillation, we examined this issue in patients being managed by primary care providers.Methods and ResultsThis was a retrospective cohort new‐user study using electronic medical records from 744 Canadian primary care clinicians. Potentially inappropriate DOAC prescribing was defined as prescribing lower or higher doses than those recommended by guidelines for patients with nonvalvular atrial fibrillation. Of the 6658 patients with nonvalvular atrial fibrillation who were prescribed a DOAC (mean age: 74.8; 55% male), 626 (9.4%) had a CHADS 2 score of 0, and 168 (2.5%) had a CHADS‐VASc score of 0. Of the DOAC prescriptions, 527 (7.7%) were deemed potentially inappropriate: 496 (7.2%) were potentially underdosed, and 31 (0.5%) were prescribed a dose that was higher than recommended. Patients were more likely to be prescribed lower‐than‐recommended doses if they were female (adjusted odds ratio [aOR]: 1.3 [95% confidence interval (CI), 1.0–1.5]), had multiple comorbidities (aOR: 1.4 [95% CI, 1.1–1.8])—particularly heart failure (aOR: 1.6 [95% CI, 1.2–2.0]) or dementia (aOR: 1.4 [95% CI, 1.1–1.8])—or if they were also taking aspirin (aOR: 1.7 [95% CI, 1.3–2.1]) or nonsteroidal anti‐inflammatory drugs (aOR: 1.2 [95% CI, 1.02–1.5]). Potentially inappropriate DOAC dosing was more common in rural practices (aOR: 2.1 [95% CI, 1.7–2.6]) or smaller practices (aOR: 1.9 [95% CI, 1.6–2.4] for practices smaller than median).ConclusionsThe vast majority of DOAC prescriptions in our cohort of primary care–managed patients appeared to be for appropriate doses, particularly since prescribing a reduced dose of DOAC may be appropriate in frail patients or those taking other medications that predispose to bleeding.

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“…Recently, several studies found that efficacy of rivaroxaban or apixaban or dabigatran versus warfarin was similar in patients with atrial fibrillation and other types of valvular heart disease. [2,28,29] In the present report, rivaroxaban can even dissolve the LAA thrombi in patients with severe mitral stenosis, indicating that this drug could be a therapeutic option for patients with mitral stenosis. However, before its use can be recommended in patients with rheumatic mitral stenosis, additional randomized data are needed to prove these preliminary findings.…”

Section: Discussionmentioning

confidence: 50%

Resolution of massive left atrial appendage thrombi with rivaroxaban before balloon mitral commissurotomy in severe mitral stenosis

Lin²,

Chen³

2016

Medicine

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Rationale:Data on nonvitamin K antagonist oral anticoagulant being used for the treatment of LAA thrombi are limited only in nonvalvular atrial fibrillation. There are no data on the antithrombotic efficacy and safety of nonvitamin K antagonist oral anticoagulant in the resolution of left atrial appendage (LAA) thrombi in patients with rheumatic mitral stenosis.Patient concerns:A 49-year-old woman with known rheumatic mitral stenosis and atrial fibrillation was referred for percutaneous transvenous mitral commissurotomy because of progressive dyspnea on exertion over a period of 3 months.Diagnoses:Transesophageal echocardiography (TEE) demonstrated a large LAA thrombus protruding into left atria cavity before the procedure.Interventions:Direct factor Xa (FXa) inhibitor rivaroxaban (20 mg/d) was started for the patient. After 3 weeks of rivaroxaban treatment TEE showed a relevantly decreased thrombus size, and a complete thrombus resolution was achieved after 5 weeks of anticoagulant therapy with the FXa inhibitor.Outcomes:To the best of our knowledge, this is the first documented case of large LAA thrombus resolution with nonvitamin K antagonist oral anticoagulant in severe mitral stenosis, and in which percutaneous transvenous mitral commissurotomy was performed subsequently.Lessons:The report indicated that rivaroxaban could be a therapeutic option for mitral stenosis patients with LAA thrombus. Further study is required before the routine use of rivaroxaban in patients with rheumatic mitral stenosis and atrial fibrillation.

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Comparison of Dabigatran and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease

Abstract: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00262600.

Cited by 141 publications

References 13 publications

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease

Use of Direct Oral Anticoagulants in Canadian Primary Care Practice 2010–2015: A Cohort Study From the Canadian Primary Care Sentinel Surveillance Network

Resolution of massive left atrial appendage thrombi with rivaroxaban before balloon mitral commissurotomy in severe mitral stenosis

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