Patients with atrial fibrillation (AF) undergoing a transcatheter aortic valve implantation (TAVI) at the same time as a left atrial appendage occlusion (LAAO) procedure using the Watchman (Boston Scientific) device had similar outcomes when compared to patients getting TAVI in addition to medical therapy or blood thinners.
Results from the WATCH TAVR trial were presented during a late-breaking clinical trial session at the 2023 TCT meeting (23–26 October, San Francisco, USA) and simultaneously published in the journal Circulation.
“WATCH TAVR is a novel study where two devices were used in order to combine the TAVI procedure for patient convenience and safety,” said lead author Samir Kapadia (Cleveland Clinic, Cleveland, USA). “If patients can get both procedures done at the same time, that eliminates the need to be on blood thinners, which can have significant side effects. In addition, many patients can not take the medications due to high risk of bleeding.”
Patients with AF undergoing TAVI have an increased risk of death, stroke and rehospitalisation compared to those without AF. The multicentre, randomised WATCH-TAVR trial set out to investigate the safety of implantation of the Watchman 2.5 device at the time of TAVI and to compare the efficacy of Watchman LAAO with contemporary medical therapy in this population of patients with an increased risk of bleeding and stroke.
The trial enrolled 349 patients with severe aortic stenosis and AF. Of these, 177 patients received TAVI plus the LAAO procedure and 172 patients received the TAVI plus medical therapy. The trial took place between December 2017 and November 2020 at 34 centres in the USA. The mean age was 81 years old.
Patients in the TAVI plus medical therapy control group were managed by their treating physician, which allowed for the use of a direct oral anticoagulant, warfarin or no blood thinners, based on the physician’s discretion. Approximately one third of patients who were in the medical therapy control group were not on blood thinners at two years.
The primary endpoint, a composite of all-cause death, stroke and major bleeding at two years, showed that there were no differences in outcomes for patients when getting TAVI plus LAAO compared to getting TAVI plus medical therapy. However, there was a higher rate of blood clots, mainly more frequent blood clots in the veins, in patients undergoing TAVI plus LAAO compared to TAVI plus medical therapy.
In the trial, the Watchman patients received blood thinners for 45 days followed by dual antiplatelet therapy (DAPT) until six months. Anticoagulation was based on the treating physician’s preference for patients randomised to TAVI plus medical therapy.
At baseline, 85.4% of patients were taking blood thinners and 71.3% of patients were on antiplatelet therapy. After 24 months, 82.5% compared to 50.8% of patients were on any antiplatelet therapy, and 13.9% compared to 66.7% of patients were on any blood thinner therapy in the TAVI plus LAAO group compared to TAVI plus medical therapy group, respectively.
“Although the findings showed similar outcomes, the increased complexity and risks of the combined procedure should be considered when LAAO is viewed as an alternative to medical therapy for patients with atrial fibrillation undergoing TAVI,” said Kapadia.
The trial was coordinated by the Cleveland Clinic Coordinating Center for Clinical Research and funded by a research grant from Boston Scientific.
