In patients without an indication for long-term anticoagulation after successful TAVR, the incidence of subclinical leaflet thrombosis (SLT) was numerically lower – but not statistically significant – with edoxaban than with dual antiplatelet therapy (DAPT), according to findings from the ADAPT-TAVR trial presented April 4 at ACC.22 and published in Circulation. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between two groups, researchers said.

The study randomly assigned 229 patients (median age of 80 years; 58% women) who had undergone TAVR and did not have any indications for anticoagulation to receive either edoxaban or DAPT for six months. Patients underwent magnetic resonance imaging (MRI) scans and neurological and neurocognitive function tests within one week of their TAVR procedure and again at six months. At six-months follow up, patients received computed tomography (CT) scans to detect SLT.

Overall, 10 patients in the edoxaban group (9.8%) developed SLT that was detectable on the CT scan, compared with 20 (18.4%) of those in the DAPT group; however, this difference was not statistically significant. Rates of death, stroke, transient ischemic attack, blood clotting in the brain and problems with thinking or memory were similar in the two groups.

"The key messages from this study are that SLT has not been proven to affect clinical outcomes for patients undergoing valve replacement and that in patients in whom SLT causes no symptoms or complications, its presence should not dictate the type of antithrombotic therapy that patients receive following the implantation of an artificial heart valve," said Duk-Woo Park, MD, PhD, FACC, the study's principal investigator. "Additionally, these findings do not support the routine use of CT scans to detect SLT."

Park said the study had several limitations, including that it was not blinded and the number of patients enrolled was too small to identify any correlation between findings on MRI or CT scans and adverse events. He also noted that the six-month follow-up period was too short to determine the long-term effects of SLT or whether edoxaban or DAPT had any effect on the durability of a patient's replacement heart valve. As such, he said the results should be considered hypothesis-generating and that future studies, which are in the works, will address some of these questions and uncertainties.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: ACC Annual Scientific Session, ACC22, Transcatheter Aortic Valve Replacement, Platelet Aggregation Inhibitors, Anticoagulants, Thrombosis, Thromboembolism, Aortic Valve Stenosis, Thiazoles, Pyridines

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