Anticoagulation vs. Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement - ADAPT-TAVR

Aug 18, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
CardioVascular Research Foundation; Daiichi Sankyo Korea Co., Ltd.
Date Published:
08/09/2022
Original Posted Date:
08/18/2022
References

Contribution To Literature:

The ADAPT-TAVR trial was underpowered; however, it showed a numerical decline in valve thrombosis without reduction in cerebral events with edoxaban compared with DAPT.

Description:

The goal of the trial was to evaluate edoxaban compared with dual antiplatelet therapy (DAPT) among subjects who underwent transcatheter aortic valve replacement (TAVR) and did not have an indication for anticoagulation.

Study Design

  • Randomization
  • Parallel

Subjects who underwent TAVR and did not have an indication for anticoagulation were randomized to edoxaban (n = 111) versus DAPT (n = 118). The dose of edoxaban was 60 mg daily (30 mg daily for renal insufficiency, body weight ≤60 kg, or use of certain P-glycoprotein inhibitors).

  • Total number of enrollees: 229
  • Duration of follow-up: 6 months
  • Mean patient age: 80 years
  • Percentage female: 66%
  • Percentage with diabetes: 32%

Inclusion criteria:

  • Patients at least 18 years of age who underwent successful TAVR

Exclusion criteria:

  • Indication for anticoagulation or DAPT
  • Severe renal insufficiency

Principal Findings:

The primary outcome, incidence of valve thrombosis at 6 months, occurred in 9.8% of the edoxaban group versus 18.4% of the DAPT group (p = 0.08).

Secondary outcomes:

  • New cerebral lesions on brain magnetic resonance imaging: 25.0% in the edoxaban group versus 20.2% in the DAPT group (p = 0.4)
  • Median total new lesion number: 1 in the edoxaban group versus 1 in the DAPT group (p = 0.85)
  • Worsening of neurological function (National Institutes of Health Stroke Scale [NIHSS]): 5% in the edoxaban group versus 3.7% in the DAPT group (p = 0.74)

Interpretation:

Among subjects who underwent TAVR and did not have an indication for anticoagulation, edoxaban was associated with a numerical decline in valve thrombosis compared with DAPT. There was no difference in neurological events between the treatment groups. Limitations of this trial include being underpowered and open-label. Although subclinical leaflet thrombosis is common after TAVR, the association with neurological events and valve degeneration remains unestablished. Continued research in this area is warranted.

References:

Park DW, Ahn JM, Kang DY, et al., on behalf of the ADAPT-TAVR Investigators. Edoxaban versus dual antiplatelet therapy for leaflet thrombosis and cerebral thromboembolism after TAVR: the ADAPT-TAVR randomized clinical trial. Circulation 2022;146:466-79.

Editorial Comment: Makkar R, Chakravarty T. Missing Pieces of the Transcatheter Aortic Valve Replacement Subclinical Leaflet Thrombosis Puzzle. Circulation 2022;146:494-7.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Magnetic Resonance Imaging

Keywords: Anticoagulants, Cardiac Surgical Procedures, Geriatrics, Heart Valve Diseases, Magnetic Resonance Imaging, Platelet Aggregation Inhibitors, Renal Insufficiency, Secondary Prevention, Stroke, Thromboembolism, Thrombosis, Transcatheter Aortic Valve Replacement


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