Valve durability is a major concern after TAVI. Early valve degeneration (Hypo-attenuated leaflet thickening / HALT) has been reported in ~20% of patients on antiplatelet drugs. DOAC therapy may prevent it. HALT assessed by CT at 12 months is the first co-primary outcome.

Improved valve durability is of no value if the intervention is harmful. Will DOAC cause more bleeding? Will withholding ASA increase thromboembolic events? Will it increase mortality? Non-inferiority for this Safety Composite is the second co-primary outcome at 12 months.

In GALILEO-4D NEJM, DOAC+antiplatelet reduced valve degeneration compared to antiplatelet monotherapy. However, in the main GALILEO trial, the intervention increased mortality and events. Will DOAC monotherapy perform better in ACASA-TAVI? nejm.org/doi/full/10.10…

State of European Society of Cardiology and EACTS treatment recommendations in 2021: Oral anticoagulation has a role after SAVR, but not after TAVI. Class III is based on GALILEO, a DOAC+antiplatelet trial. No monotherapy data. Durability concerns after TAVI; lack of DOAC data? #CardioTwitter

Hypo-attenuated leaflet thickening (first co-primary outcome) at 12 months is a surrogate of clinical outcome. ACASA-TAVI will therefore report the effect of 12 month DOAC monotherapy on hard clinical outcomes / MACE at 5 and 10 years.

ACASA-TAVI is a PROBE trial, in which outcomes will be adjudicated by a blinded outcome committee. They receive pseudonymized raw data and will categorize hypo-attenuated leaflet thickening and other key outcomes without knowledge of randomization group or other characteristics.

The first key secondary outcome at 12 months is to assess effect of DOAC on "Clinical Efficacy" as defined in VARC-3. The importance of this outcome was highlighed by the user panel LHL during the trial planning.

ACASA-TAVI is an industry independent trial. The choice of anti factor Xa type DOAC agent in the intervention arm will be made after shared decision making between the patient and physician.

Six boxes of assorted anti factor Xa type non-vitamin K oral anticoagulants, one fifth of the total study medication for the intervention arm. The trial starts on December 2nd.

As of today, ACASA-TAVI is approved and recruiting at Oslo University Hospital, Rikshospitalet

We are on our way! The first patients have been included and randomized.

It is a great day for ACASA-TAVI! Patient number 7 was included and randomized, and the trial received an open public research grant from @helsesorost. Thank you!

Accepting applications for PhD-fellowship supervised by Øyvind H Lie and co-workers in ACASA-TAVI at Section for Interventional Cardiology, Department of Cardiology, Oslo University Hospital Rikshospitalet Oslounivsykehus @helsesorost 2411.webcruiter.no/Main2/Recruit/…

ACASA-TAVI has reached 5% inclusion. There is a long road ahead to establish the optimal anti-thrombotic therapy after TAVI, but we are en route!

A great day for ACASA-TAVI! What a privilege it is to have a strong cardiology clinician join the team as a PhD fellow. Welcome on board chrisdodgson!

Patient number 50 was randomized today! Inclusion is steady at the anticipated rate.

Inclusion is steady at the anticipated rate. 100 patients have been randomized at Oslounivsykehus!

Blodfortynnende etter #TAVI: Hva vet vi og hva trenger vi å vite? Bakgrunn og rasjonale for #ACASATAVI, en ny norsk RCT ledet av Øyvind H Lie legeforeningen.no/contentassets/…

The ACASA-TAVI methods paper is now published in AmericanHeartJ sciencedirect.com/science/articl…

Inclusion in the ACASA-TAVI trial is closed! All participants have been randomized to NOAC or ASA following successful TAVI. We are one step closer to understanding optimal antithrombotic therapy after TAVI! Oslounivsykehus Haukeland