BACKGROUND:Atrial fibrillation is the most common significant cardiac arrhythmia and substantially impacts the health status of patients. Enoxaparin has been shown to be a safe and effective alternative to unfractionated heparin for use with transesophageal echocardiography (TEE)-guided cardioversion, but the implications on health status remain unknown. The aim of the study was to compare the health status outcomes of patients who undergo TEE-guided cardioversion withenoxaparin or unfractionated heparinas anticoagulation bridging therapy. METHODS: The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II multicenter trial randomized 155 patients to bridging therapy with eitherenoxaparin or unfractionated heparin. Of these, 118 were included in the health status substudy. Health status was assessed at baseline and 5 weeks using the RAND 36-item health survey (RAND-36), the Duke Activity Status Index (DASI), and the Health Utilities Index Mark 3 (HUI-3). RESULTS: There were no significant differences in the health status measures between the treatment groups. However, patients who remained in normal sinus rhythm at follow-up had absolute improvement in all measures of health status, whereas patients in atrial fibrillation at follow-up had an absolute decrease in the DASI, HUI-3, and 5 of 8 subscales of the RAND-36. These findings reached statistical significance in the HUI-3 and 3 of 8 subscales of the RAND-36. CONCLUSIONS:Health status outcomes in TEE-guided cardioversion do not significantly differ between anticoagulant bridging therapy with enoxaparin or unfractionated heparin. However, maintenance of sinus rhythm at 5 weeks was associated with an improvement in health status.
RCT Entities:
BACKGROUND:Atrial fibrillation is the most common significant cardiac arrhythmia and substantially impacts the health status of patients. Enoxaparin has been shown to be a safe and effective alternative to unfractionated heparin for use with transesophageal echocardiography (TEE)-guided cardioversion, but the implications on health status remain unknown. The aim of the study was to compare the health status outcomes of patients who undergo TEE-guided cardioversion with enoxaparin or unfractionated heparin as anticoagulation bridging therapy. METHODS: The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II multicenter trial randomized 155 patients to bridging therapy with either enoxaparin or unfractionated heparin. Of these, 118 were included in the health status substudy. Health status was assessed at baseline and 5 weeks using the RAND 36-item health survey (RAND-36), the Duke Activity Status Index (DASI), and the Health Utilities Index Mark 3 (HUI-3). RESULTS: There were no significant differences in the health status measures between the treatment groups. However, patients who remained in normal sinus rhythm at follow-up had absolute improvement in all measures of health status, whereas patients in atrial fibrillation at follow-up had an absolute decrease in the DASI, HUI-3, and 5 of 8 subscales of the RAND-36. These findings reached statistical significance in the HUI-3 and 3 of 8 subscales of the RAND-36. CONCLUSIONS: Health status outcomes in TEE-guided cardioversion do not significantly differ between anticoagulant bridging therapy with enoxaparin or unfractionated heparin. However, maintenance of sinus rhythm at 5 weeks was associated with an improvement in health status.
Authors: Geoffrey D Barnes; Scott Kaatz; Julia Winfield; Xiaokui Gu; Brian Haymart; Eva Kline-Rogers; Jay Kozlowski; Dennis Beasley; Steve Almany; Tom Leyden; James B Froehlich Journal: J Thromb Thrombolysis Date: 2014 Impact factor: 2.300