All-cause mortality, stroke, and bleeding in patients with atrial fibrillation and valvular heart disease

Abstract

Aims To compare the risk of all-cause mortality, stroke, and bleeding in patients with atrial fibrillation (AF) and valvular heart disease (VHD) treated with vitamin K antagonist (VKA) or factor Xa-inhibitors (FXa-I; rivaroxaban and apixaban). Methods and results We cross-linked data from Danish nationwide registries identifying patients with AF and VHD (aortic stenosis/insufficiency, mitral insufficiency, bioprosthetic heart valves, mitral-, and aortic valve repair) initiating VKA or FXa-I between January 2014 and June 2017. Outcomes were all-cause mortality, stroke, and bleeding. Using cause-specific Cox regression, we reported the standardized absolute 2-year risk of the outcomes and absolute risk differences (ARD). We identified 1115 (41.7%), 620 (23.1%), and 942 (35.2%) patients initiating treatment with VKA, rivaroxaban, and apixaban, respectively. The standardized absolute risk (95% confidence interval) of all-cause mortality associated with VKA treatment was 34.1% (30.4–37.8%) with corresponding ARD for FXa-I of −2.7% (−6.7% to 1.4%). The standardized absolute risk of stroke for VKA was 3.8% (2.2–5.4%) with corresponding ARD for FXa-I of –0.1% (−2.0% to 1.8%). The standardized risk of bleeding for VKA was 10.4% (7.2–12.9%) with corresponding ARD for FXa-I of –2.0% (−5.1% to 1.1%). The risk of bleeding was significantly reduced in subgroup analyses of apixaban compared with VKA [ARD: −3.9% (−7.0% to −0.9%)] and rivaroxaban [ARD: −5.6% (−9.5% to −1.7%)]. Conclusion In this nationwide cohort study, there were no significant differences in the risks of all-cause mortality, stroke, and bleeding in patients with AF and VHD treated with VKA compared with FXa-I.

Thromboembolic and bleeding outcomes in patients with atrial fibrillation and valvular heart disease: A descriptive nationwide cohort study

“…Future studies examining the optimal antithrombotic management in each subgroup of EHRA Type 1 VHD and EHRA Type 2 VHD are needed. Several studies have examined the effectiveness and safety of NOAC vs warfarin in AF patients with VHD, primarily in patients with EHRA Type 2 VHD 25‐32 . Meta‐analyses of post hoc analyses of previous randomised trials examining NOAC vs warfarin in AF patients with VHD showed that when pooling the results there was a reduced risk of thromboembolism in the NOAC group and no difference in the risk of major bleeding 33‐36 .…”

“…Meta‐analyses of post hoc analyses of previous randomised trials examining NOAC vs warfarin in AF patients with VHD showed that when pooling the results there was a reduced risk of thromboembolism in the NOAC group and no difference in the risk of major bleeding 33‐36 . However, in several comparative analyses based on real‐world data, the benefits of NOAC compared with warfarin were inconsistent 25‐28,32 . Until more evidence regarding the antithrombotic management of this population is available, clinicians are encouraged to use the EHRA classification and international guideline recommendations for guidance regarding stroke prevention in AF patients with VHD 11…”

Off-label Use for Direct Oral Anticoagulants: Valvular Atrial Fibrillation, Heart Failure, Left Ventricular Thrombus, Superficial Vein Thrombosis, Pulmonary Hypertension—a Systematic Review

“…Five real-world retrospective studies have also been conducted concerning the use of DOACs for VAF (Table 1). The retrospective cohort study using the Danish National Patient Registry by Strange et al 28 found no significant differences in stroke/SEE, major bleeding, and all-cause mortality rates between the DOAC (rivaroxaban or apixaban) and warfarin groups. However, this study relied on diagnostic codes for reporting outcomes.…”

Rivaroxaban is Comparable to Warfarin in Prevention of Thromboembolism in Patients with Non-Valvular Atrial Fibrillation with Valvular Heart Disease: A Systematic Review and Meta-analysis

“…[Insert figure 1] June 30, 2017. This study identified data from nationwide Danish registries with follow up until death, event, migration, switch, or discontinuation of treatment (11). The baseline characteristics of included studies were extracted and has been listed in table 1.…”