In the PROTECT AF trial, patients randomized to left atrial appendage closure initially continued taking warfarin and aspirin to promote device endothelialization. At 45 days after the procedure, 86.8% of patients receiving device closure were able to discontinue warfarin, and 93.2% discontinued warfarin within one year.

After randomization, 8.2% of patients did not receive the intervention to which they were randomized, and 15% of patients withdrew or were lost to follow-up before the four-year evaluation, but all patients were included in analysis.

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Comparing device closure versus warfarin during a mean follow-up duration of 3.8 years (2,621 patient-years), device closure was associated with a decreased risk of hemorrhagic stroke (0.2 per 100 patient-years vs. 1.1 per 100 patient-years; P<0.05), cardiovascular or unexplained death (1 per 100 patient-years vs. 2.4 per 100 patient-years; P<0.05), and all-cause mortality (3.2 per 100 patient-years vs. 4.4 per 100 patient-years; P=0.04). No significant differences were observed in rate of any stroke, ischemic stroke, or adverse events.

The results suggest that left atrial appendage device closure appears as effective as anticoagulation with warfarin for preventing ischemic stroke and may improve cardiovascular and overall mortality while reducing risk of hemorrhagic stroke.

The initial trial report found that device closure had more adverse events than warfarin, but most adverse events related to device closure occurred in the periprocedural period, while adverse events associated with warfarin occurred throughout the follow-up.

Therefore, during four years of follow-up, the rate of adverse events evened out between the two interventions. Device closure may be especially appealing for patients with increased bleeding risk and those unable or unwilling to follow the monthly monitoring routine required with warfarin use.

Alan Ehrlich, MD, is a deputy editor for DynaMed, in Ipswich, Mass., and assistant clinical professor in Family Medicine, University of Massachusetts Medical School in Worcester.

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