Apixaban for stroke prevention in subclinical atrial fibrillation detected by an implantable cardiac monitor: a subgroup analysis of ARTESiA.
Journal Articles
Overview
Research
Identity
Additional Document Info
View All
Overview
abstract
BACKGROUND: The ARTESiA trial randomized patients with pacemaker, implantable cardioverter-defibrillator (ICD), or implantable cardiac monitor (ICM), and with subclinical atrial fibrillation to either apixaban or aspirin. OBJECTIVE: We aimed to explore the effects of apixaban in the subset of patients with an ICM. METHODS: We assessed the efficacy outcome of stroke or systemic embolism (SE) and the safety outcome of major bleeding, stratifying by device type. RESULTS: Of 4,012 participants, 209 (5.2%) had ICM and 3,803 (94.8%) had pacemaker/ICD. Patients with ICM were younger (74.9±7.4 vs 76.9±7.6 years), more likely to be female (50.2% vs 35.3%) and to have a prior stroke (24.9% vs 7.7%) than those with pacemaker/ICD. In the ICM cohort, stroke/SE occurred in 1 of 103 in the apixaban group (0.3%/year) vs 9 of 106 in the aspirin group (2.6%/year); HR 0.11 [95% CI: 0.01-0.88] and ARR 2.31%/year [95% CI: 0.55-4.07]. The corresponding rates in the pacemaker/ICD cohort were 0.8%/year with apixaban vs 1.2%/year with aspirin; HR 0.69 [95% CI: 0.49-0.98] and ARR 0.36%/year [95% CI: 0.02-0.70] (pinteraction=0.078 and 0.002, respectively). Among patients with ICM, major bleeding occurred at 1.3%/year vs 1.1%/year for apixaban vs aspirin; HR 1.13 [95% CI: 0.30-4.31]. No significant difference in HR or ARR was observed across the device types (pinteraction=0.808 and 0.406, respectively). CONCLUSION: In ARTESiA, patients with ICM experienced a stroke rate at 2.6%/year on aspirin, higher than that in the remaining trial population. The risk was significantly reduced by apixaban, consistent with the overall ARTESiA results.
