The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial

  • STATUS
    Recruiting
  • End date
    Mar 21, 2024
  • participants needed
    6215
  • sponsor
    Population Health Research Institute
Updated on 21 August 2021

Summary

The DANCE Trial is a multi-centre, randomized controlled trial comparing the safety of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in the early period (30 days) after cardiac surgery in patients with an indication for oral anticoagulation.

Description

Approximately 36,000 Canadian adults undergo cardiac surgery annually. Of these patients, about 10% have a prior history of atrial fibrillation (AF). In the early post-operative period after cardiac surgery, 30-60% of patients develop AF and, by the time of discharge, 32% of patients who underwent cardiac surgery have an indication for oral anticoagulation (OAC). AF is associated with a significantly higher risk of stroke, even when transient, and OAC is the standard for thromboembolic prevention in these patients. In the post-operative period, the balance of benefits and risks of OAC may differ and the safest and most effective OAC in that patient population is uncertain.

Vitamin K antagonists (VKAs), such as warfarin or coumadin, are the most used anticoagulants after cardiac surgery. In the Left Atrial Appendage Occlusion Study (LAAOS) III, 77% of patients with AF on OAC were discharged on a VKA after cardiac surgery with 55% of the patients presenting on a direct oral anticoagulant (DOAC) being switched to a VKA! Although effective, their use is limited by a narrow therapeutic index requiring frequent international normalized ratio (INR) measurements to ensure appropriate levels of anticoagulation. This key limitation leads to non-compliance and discontinuation. In addition, in the first 3 months after cardiac surgery, time in the therapeutic range is low, even with close monitoring by experienced prescribers.

In the last decade, DOACs - inhibitors of factor Xa or thrombin- have become broadly used in patients with AF. Treatment with a DOAC in patients with AF has been demonstrated to yield a lower risk of stroke or systemic embolism and a similar risk of major bleeding when compared to VKAs during long-term follow-up. Moreover, DOACs are more convenient for both patients and clinicians. They have a rapid onset of effect, fixed dosage that obviates the need for regular monitoring, and few interactions with food and other medications. In the postoperative setting, DOACs may also lead to shorter length of stay and reduced costs.

The purpose of this study is to establish whether DOACs are as safe as VKAs in the first few weeks after heart surgery. The results of this study will impact the treatment of hundreds of thousands of patients in the world every year.

Details
Condition Bleeding Post Cardiac Surgery, Indication for Anticoagulation
Treatment VKA, DOAC
Clinical Study IdentifierNCT04284839
SponsorPopulation Health Research Institute
Last Modified on21 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years at the time of enrolment
Open heart surgery in the last 7 days
Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation)
Informed consent from either the patient or a substitute decision-maker

Exclusion Criteria

Mechanical valve replacement
Antiphospholipid syndrome (triple positive)
Severe renal failure (Cockcroft-Gault equation; creatinine clearance <30 ml/min)
Known significant liver disease (Child-Pugh classification B and C)
Left ventricular thrombus
Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
Known contraindication for any DOAC or VKA
Women who are pregnant, breastfeeding, or of childbearing potential
Previously enrolled in this trial
Follow-up not possible
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