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Published on: February 26, 2013
Anticoagulation in device-detected atrial fibrillation with or without vascular disease: a combined analysis of the
Renate B Schnabel1,2,3, Juan Benezet-Mazuecos4, Nina Becher1,2
1Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany.
Insights
Patients with device-detected atrial fibrillation (DDAF) and vascular disease may benefit more from anticoagulation therapy. This therapy reduces stroke and cardiovascular events in these high-risk individuals.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- Optimal antithrombotic therapy for device-detected atrial fibrillation (DDAF) remains undetermined.
- Concomitant vascular disease may influence the risk-benefit profile of anticoagulation in DDAF patients.
Purpose of the Study:
- To evaluate the efficacy and safety of anticoagulation in DDAF patients with and without concomitant vascular disease.
- To determine if vascular disease status modifies the treatment effect of anticoagulation.
Main Methods:
- Pre-specified analyses of the NOAH-AFNET 6 and ARTESiA trials.
- Comparison of anticoagulation versus no anticoagulation in DDAF patients stratified by presence of vascular disease (prior stroke/TIA, coronary/peripheral artery disease).
- Assessment of composite efficacy outcomes (stroke, systemic embolism, myocardial infarction, cardiovascular death) and safety outcomes (major bleeding).
Main Results:
- In patients with vascular disease, anticoagulation showed a trend towards reducing major adverse cardiovascular events compared to no anticoagulation.
- In patients without vascular disease, outcomes were similar between anticoagulation and no anticoagulation groups.
- Anticoagulation increased major bleeding risk in both vascular disease and no vascular disease groups, with a higher incidence rate ratio in the latter.
Conclusions:
- DDAF patients with vascular disease face higher risks of stroke and cardiovascular events.
- These patients may experience greater net benefit from anticoagulation therapy compared to DDAF patients without vascular disease.
Background And Aims:
The optimal antithrombotic therapy in patients with device-detected atrial fibrillation (DDAF) is unknown. Concomitant vascular disease can modify the benefits and risks of anticoagulation.
Methods:
These pre-specified analyses of the NOAH-AFNET 6 (n = 2534 patients) and ARTESiA (n = 4012 patients) trials compared anticoagulation with no anticoagulation in patients with DDAF with or without vascular disease, defined as prior stroke/transient ischaemic attack, coronary or peripheral artery disease. Efficacy outcomes were the primary outcomes of both trials, a composite of stroke, systemic arterial embolism (SE), myocardial infarction, pulmonary embolism or cardiovascular death, and stroke or SE. Safety outcomes were major bleeding or major bleeding and death.
Results:
In patients with vascular disease (NOAH-AFNET 6, 56%; ARTESiA, 46%), stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred at 3.9%/patient-year with and 5.0%/patient-year without anticoagulation (NOAH-AFNET 6), and 3.2%/patient-year with and 4.4%/patient-year without anticoagulation (ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (NOAH-AFNET 6, 2.7%/patient-year; ARTESiA, 2.3%/patient-year in both randomized groups). Meta-analysis found consistent results across both trials (I2heterogeneity = 6%) with a trend for interaction with randomized therapy (pinteraction = .08). Stroke/SE behaved similarly. Anticoagulation equally increased major bleeding in vascular disease patients [edoxaban, 2.1%/patient-year; no anticoagulation, 1.3%/patient-year; apixaban, 1.7%/patient-years; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.55 (1.10-2.20)] and without vascular disease [edoxaban, 2.2%/patient-year; no anticoagulation, 0.6%/patient-year; apixaban, 1.4%/patient-year; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.93 (0.72-5.20)].
Conclusions:
Patients with DDAF and vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from anticoagulation than patients with DDAF without vascular disease.
