Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Valvular Heart Disease Other Than Significant Mitral Stenosis and Mechanical Valves
2017; Lippincott Williams & Wilkins; Volume: 135; Issue: 7 Linguagem: Inglês
10.1161/circulationaha.116.026793
ISSN1524-4539
AutoresKonstantinos C. Siontis, Xiaoxi Yao, Bernard J. Gersh, Peter A. Noseworthy,
Tópico(s)Cardiac Valve Diseases and Treatments
ResumoHomeCirculationVol. 135, No. 7Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Valvular Heart Disease Other Than Significant Mitral Stenosis and Mechanical Valves Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBDirect Oral Anticoagulants in Patients With Atrial Fibrillation and Valvular Heart Disease Other Than Significant Mitral Stenosis and Mechanical ValvesA Meta-Analysis Konstantinos C. Siontis, MD, Xiaoxi Yao, PhD, Bernard J. Gersh, MB, ChB, DPhil and Peter A. Noseworthy, MD Konstantinos C. SiontisKonstantinos C. Siontis From Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (K.C.S.); and Division of Health Care Policy and Research, Department of Health Sciences Research (X.Y.) and Division of Cardiovascular Diseases (B.J.G., P.A.N.), Mayo Clinic, Rochester, MN. , Xiaoxi YaoXiaoxi Yao From Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (K.C.S.); and Division of Health Care Policy and Research, Department of Health Sciences Research (X.Y.) and Division of Cardiovascular Diseases (B.J.G., P.A.N.), Mayo Clinic, Rochester, MN. , Bernard J. GershBernard J. Gersh From Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (K.C.S.); and Division of Health Care Policy and Research, Department of Health Sciences Research (X.Y.) and Division of Cardiovascular Diseases (B.J.G., P.A.N.), Mayo Clinic, Rochester, MN. and Peter A. NoseworthyPeter A. Noseworthy From Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (K.C.S.); and Division of Health Care Policy and Research, Department of Health Sciences Research (X.Y.) and Division of Cardiovascular Diseases (B.J.G., P.A.N.), Mayo Clinic, Rochester, MN. Originally published14 Feb 2017https://doi.org/10.1161/CIRCULATIONAHA.116.026793Circulation. 2017;135:714–716IntroductionThe introduction of direct oral anticoagulants (DOACs) transformed the approach to thromboembolic prophylaxis in atrial fibrillation (AF), but uncertainty remains about the use of these medications in patients with valvular heart disease (VHD). The randomized controlled trials (RCTs) that established the favorable clinical profile of DOACs excluded patients with valvular AF, referring to hemodynamically significant mitral stenosis and mechanical valves. However, the definition of this term is inconsistent in the literature. Although other forms of VHD were included in the trials, many clinicians are hesitant to prescribe DOACs in patients with some degree of VHD. Limited data pertain specifically to this population, mostly from post hoc analyses of RCTs. Therefore, we sought to address the effectiveness and safety of DOACs in patients with VHD by synthesizing all available RCT data.We searched the Medline, Cochrane Central Register of Controlled Trials, and Embase databases (accessed November 9, 2016) and presentations in major cardiology meetings within the last year (American Heart Assocation, American College of Cardiology, European Society of Cardiology, Heart Rhythm Society) for RCTs (or secondary analyses thereof) comparing the currently approved DOACs to warfarin and reporting outcomes for patients with AF and VHD other than hemodynamically significant mitral stenosis and mechanical valves. We documented hazard ratios and 95% confidence intervals for stroke/systemic embolism and major bleeding, adhering to the VHD and outcome definitions of each individual study. Meta-analysis estimates were calculated with random-effects DerSimonian-Laird model for the effect of DOACs versus warfarin in subgroups of patients with and without VHD, and we assessed whether differential effects were found in the 2 subgroups. Heterogeneity across studies was assessed with the I2 statistic. Analyses were performed in Stata 14.1 (StataCorp).We identified 1525 studies that were assessed at the title/abstract level. Eleven potentially eligible studies were assessed further, and 4 were finally included. These studies were secondary analyses of multicenter, international RCTs comparing apixaban,1 dabigatran,2 edoxaban,3 and rivaroxaban4 to warfarin. The eligible studies included the following valve lesions: aortic stenosis/regurgitation, mild mitral stenosis, mitral regurgitation, tricuspid stenosis/regurgitation in all studies; bioprosthetic valves in 2 studies; and annuloplasty or valvuloplasty in 3 studies. Lesions had to be of at least moderate severity to qualify for the VHD groups in the main analyses, except for the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulant Therapy), which also included mild severity lesions in the VHD group. Patients in the warfarin groups were within therapeutic international normalized ratio range for mean 62.2%, 64.9%, 64%, and 55% of the time in ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48), RE-LY, and ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trials, respectively. For dabigatran and edoxaban, the comparisons of the respective doses of 150 mg and 60 mg were used in meta-analyses. Our analyses included 58 497 patients (29 284 DOAC-treated and 29 213 warfarin-treated) with 2018 stroke/systemic embolism and 3284 major bleeding events.By random-effects meta-analysis (Figure), DOACs decreased the risk of stroke/systemic embolism compared with warfarin in patients with (hazard ratio, 0.70; 95% confidence interval, 0.58–0.86) and without VHD (hazard ratio, 0.84; 95% confidence interval, 0.75–0.95). No significant heterogeneity was found, and the summary effects did not differ significantly in the VHD and non-VHD subgroups (P-for-interaction=0.11). The summary effects were also similar in the 2 subgroups for the major bleeding outcome (P-for-interaction=0.64) and indicated no significant difference exists between DOACs and warfarin. However, significant heterogeneity was discovered in both the VHD and non-VHD meta-analyses for major bleeding (I2=79% and 81%, respectively). The major contributors to treatment effect heterogeneity were the comparatively increased bleeding rate in the rivaroxaban-treated VHD subgroup and the decreased bleeding rate in the apixaban-treated patients in the non-VHD subgroup.Download figureDownload PowerPointFigure. Forest plots. Meta-analysis of DOACs versus warfarin for (a) stroke and systemic embolism, and (b) major bleeding in patients with and without VHD. The comparisons of the standard approved dabigatran 150 mg and edoxaban 60 mg were included in analyses. CI indicates confidence interval; DOAC, direct oral anticoagulant; HR, hazard ratio; Pint, interaction P-value; n/a, not available; and VHD, valvular heart disease.In this meta-analysis of published data from 4 large RCTs, DOACs were more effective than warfarin for thromboembolic prophylaxis in patients with AF with and without VHD and were not associated with overall differences in risks of major bleeding. No evidence was found of differential effects of DOACs versus warfarin based on VHD status for either outcome. Although the absence of a statistically significant interaction term of the VHD and non-VHD summary effects cannot definitively exclude subtle differences in the comparative effects of the 2 interventions for those with versus without VHD, the meta-analysis estimates were comparable in magnitude and direction of effect for patients with and without VHD in all comparisons. These data allow physicians the freedom to use DOACs in patients across a broad spectrum of native VHD and support a limited definition of valvular AF to include only patients with hemodynamically significant mitral stenosis or mechanical valves, as was used in the randomized trials, which would preclude the consideration for DOAC use. Findings were consistent among the primary studies for stroke/systemic embolism prevention, but we observed more heterogeneity in the analyses of major bleeding. This finding was driven by the comparatively higher bleeding rates in rivaroxaban-treated patients with VHD and lower bleeding rates in apixaban-treated patients without VHD versus warfarin. A recent exploratory analysis of the rivaroxaban clinical trial data demonstrated that the bleeding risk may vary depending on the type of VHD because it was highest in aortic stenosis, followed by mitral or aortic regurgitation.5 The reasons for increased bleeding with aortic stenosis are unknown but could be related to an acquired coagulopathy and bleeding from intestinal angiodysplasia (Heyde's syndrome) in some patients. However, the proportion of VHD patients with aortic stenosis was similar among the VHD groups in all the studies, suggesting that additional factors might be contributing to the increased bleeding with rivaroxaban. Regardless, the potentially unfavorable effect of rivaroxaban should be interpreted with caution because it is derived from post hoc analyses of a randomized trial.This meta-analysis of summarized published data, rather than individual patient data, may be subject to inherent limitations related to variations in definition of VHD, anticoagulation practices, and outcome definition or adjudication among the included studies. Furthermore, the high level of heterogeneity (I2>60%) is a limitation of the meta-analysis for bleeding. However, our study provides evidence in support of the notion that the presence of VHD, aside from hemodynamically significant mitral stenosis and mechanical valves, should not preclude the use of DOACs. Their effectiveness and safety profile suggests that they may be considered as first-line agents in patients with or without VHD.DisclosuresDr Gersh has been on the advisory boards of Bristol-Myers-Squibb and Janssen Pharmaceuticals. The other authors have nothing to disclose.FootnotesCirculation is available at http://circ.ahajournals.org.Correspondence to: Peter A. Noseworthy, MD, Division of Cardiovascular Diseases, 200 1st St SW, Mayo Clinic, Rochester, MN 55905. E-mail [email protected]References1. Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, Pais P, Erol C, Diaz R, Bahit MC, Bartunek J, De Caterina R, Goto S, Ruzyllo W, Zhu J, Granger CB, Alexander JH.Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease: findings from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.Circulation. 2015; 132:624–632. doi: 10.1161/CIRCULATIONAHA.114.014807.LinkGoogle Scholar2. 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