The risk of thromboembolism may be higher than the clinical benefit of oral anticoagulation in patients with atrial fibrillation (AFib) with evaluated heart valves, rheumatic or artificial (EHRA) type 2 valvular heart disease (VHD) who are not receiving oral anticoagulation currently, according to a study presented as a poster during ESC Congress 2020 and simultaneously published in JACC: Clinical Electrophysiology.

Line Melgaard, MSc, PhD, et al., evaluated the thromboembolism risk in AFib patients with and without EHRA type 2 VHD who were not on oral anticoagulant therapy. The researchers also looked at the risk of thromboembolism in patients with a risk profile in whom guidelines recommend that oral anticoagulant therapy should be considered. The primary study outcome was a thromboembolic event, defined as ischemic stroke or systemic embolism.

The study cohort consisted of 55,613 Danish patients ≥18 years with an AFib diagnosis. Patients were divided into four subgroups based on CHA2DS2-VASc score-related comorbidities (congestive heart failure, hypertension, diabetes and vascular disease) and the presence of EHRA type 2 VHD: those without EHRA type 2 VHD and no comorbidities (41,120); those with EHRA type 2 VHD and no comorbidities (1,253); those without EHRA type 2 and one comorbidity (12,586); and those with EHRA type 2 and one comorbidity (654). The risk of thromboembolism was calculated one year and five years following AFib diagnosis.

After one year, in the two subgroups of patients with no comorbidities, the thromboembolism risk was 0.8% in those without EHRA type 2 VHD (95% confidence interval [CI], 0.4%-0.6%; 301 events) and 1.4% in those with EHRA type 2 VHD (95% CI, 0.5%-2.4%; 14 events). In patients with one comorbidity, the risk was 1.2% in patients without EHRA type 2 VHD (95% CI, 1%-1.4%; 135 events) and 1.1% in those with EHRA type 2 VHD (95% CI, 0.4%-2.2%; six events). In all patients <65 years with EHRA type 2 VHD, the risk was 1.5% regardless of whether comorbidities were present.

At five years, among patients with no comorbidities, the risk was 2.6% in patients without EHRA type 2 VHD (95% CI, 2.4%-2.8%; 824 events) and 3.5% in those with EHRA type 2 VHD (95% CI, 2.3%-5.0%; 28 events). Meanwhile, among patients with one comorbidity, the risk was 3.5% for individuals without EHRA type 2 VHD (95% CI, 3.1%-3.9%; 322 events) and 3.7% in those with EHRA type 2 VHD (95% CI, 2.1 %-6%; 16 events).

According to the researchers, the findings suggest the thromboembolism risk "may exceed the level above which oral anticoagulation is considered beneficial" in AFib patients with EHRA Type 2 VHD who are not currently recommended oral anticoagulant therapy." Further research looking at the benefit of anticoagulation in patients with EHRA type 2 VHD "would provide more definite evidence regarding whether these patients should be recommended lifelong oral anticoagulation," they conclude.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Valvular Heart Disease, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Hypertension

Keywords: ESC20, ESC Congress, Atrial Fibrillation, Stroke, Confidence Intervals, Brain Ischemia, Thromboembolism, Embolism, Anticoagulants, Heart Valve Diseases, Heart Valves, Comorbidity, Hypertension, Heart Failure, Electrophysiology, Diabetes Mellitus, Type 2

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