Watchman FLX Gets DAPT Option Added to Label

Dual antiplatelet therapy (DAPT) can be used for 45 days after implantation of the Watchman FLX left atrial appendage closure device (Boston Scientific), according to labeling changes approved by the US Food and Drug Administration.

Up until now, the recommended postprocedural regimen on the label of the Watchman FLX, and the earlier Watchman 2.5 device, was 45 days of oral anticoagulation plus aspirin based on what was used in the pivotal trials. The addition of DAPT as an option was announced Tuesday by Boston Scientific.

DAPT is the recommended antithrombotic approach on the label of another LAA occlusion device, the Amplatzer Amulet (Abbott), with oral anticoagulation recommended only when residual flow around the device is greater than 5 mm.

The revised labeling for Watchman FLX "provides physicians more flexibility to exercise their clinical judgment based on individual patient characteristics to determine the most appropriate postprocedural antithrombotic medication regimen," Ian Meredith, MBBS, PhD, Boston Scientific’s global chief medical officer, said in a press release.

The company said it submitted data from the LAAO Registry, part of the National Cardiovascular Data Registry, to support the change, and pointed to other studies establishing the safety and effectiveness of using DAPT after implantation of the Watchman FLX.

A presentation at TVT 2022 on Watchman FLX explored the comparative effectiveness of DAPT versus either a direct oral anticoagulant or warfarin plus aspirin. After propensity matching, there were no differences in the rate of a composite of death, stroke, or major bleeding—or any of the individual components or device-related thrombus—when comparing DAPT with either of the anticoagulation-based regimens.

Boston Scientific noted that labeling for the Watchman devices in Europe has listed DAPT as an accepted alternative to oral anticoagulation plus aspirin since 2017.