Dataset Information

Comparison of the New Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation and Valvular Heart Disease: Systematic Review and Meta-Analysis.

ABSTRACT:

Introduction

New oral anticoagulants (NOACs) are approved for use in nonvalvular atrial fibrillation (AF).

Objectives

This study aimed to evaluate the efficacy and safety of NOACs compared with warfarin in AF and valvular heart disease (VHD).

Methods

We identified randomized controlled trials (RCTs) and post-hoc analyses comparing NOACs and warfarin in AF and VHD, including biological and mechanical heart valves (MHV). Through systematic review and meta-analysis, with the aid of the "Rev Man" program 5.3, the primary effectiveness endpoints were stroke and systemic embolism (SE). The primary safety outcome was major bleeding, and the secondary outcome included intracranial hemorrhage. Data were analyzed using risk ratios (RRs) and 95% confidence intervals (CIs), and heterogeneity was assessed using the I² statistic.

Results

Six RCTs were included, involving 13,850 patients with AF and VHD. NOACs significantly reduced the risk of stroke/SE (RR 0.78; 95% CI 0.66-0.91; P = 0.002) and intracranial hemorrhage (RR 0.51; 95% CI 0.33-0.79; P = 0.003) and lowered the risk of major bleeding (RR 0.77; 95% CI 0.58-1.02; P = 0.07) compared with warfarin.

Conclusions

The efficacy and safety of NOACs as thromboprophylaxis for AF and VHD are similar to those of warfarin.

SUBMITTER: de Souza Lima Bitar Y

PROVIDER: S-EPMC6544604 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:We 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.We 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.In 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.

Project description:BackgroundDirect-acting oral anticoagulants (DOACs) have demonstrated superior efficacy in preventing stroke and death compared with warfarin in patients with atrial fibrillation (AF), but their influence on dementia risk remains unclear.ObjectivesThe purpose of this study was to evaluate the relative risks of dementia in DOAC vs warfarin in patients with AF.MethodsAn electronic literature search was conducted to retrieve studies reporting comparisons of dementia incidence between patients treated with DOACs and warfarin for AF. HRs and 95% CI were pooled in a random-effects meta-analysis. Meta-regression was performed to identify prognostic baseline variables. Network meta-analysis was performed to determine dementia risk between individual DOACs and warfarin.ResultsTen studies (n = 342,624) were retrieved. DOAC was associated with a significantly lower risk of developing dementia compared with warfarin (HR: 0.88; 95% CI: 0.80-0.98; P = 0.017; I2 = 75%); significance was also seen in Asian patients (HR: 0.81; 95% CI: 0.68-0.86) but not non-Asian patients. Subgroup analyses of propensity score-matched studies and patients aged 65-75 years showed similar significance, but not for patients aged ≥75 years. Meta-regression found that a lower mean age corresponded to significantly greater favoring of DOAC over warfarin. Network meta-analysis found significant reductions in dementia risk over warfarin for rivaroxaban (HR: 0.854; 95% CI: 0.763-0.955), apixaban (HR: 0.881; 95% CI: 0.778-0.997), and dabigatran (HR: 0.871; 95% CI: 0.770-0.987); the highest-ranked treatment based on P scores was edoxaban.ConclusionsThe use of DOAC in AF significantly reduces dementia risk compared with warfarin, particularly in Asian patients. The possible reversal of this effect with increasing age merits further randomized trials with long-term follow-up. (Dementia Risk of Direct Oral Anticoagulants Versus Warfarin for Atrial Fibrillation: A Systematic Review and Meta-Analysis; CRD42022365634).