A Randomized Controlled Trial of Continued Versus Interrupted Direct Oral Anti-Coagulant at the Time of Device Surgery - BRUISE CONTROL-2

Contribution To Literature:

The BRUISE CONTROL-2 trial showed that a strategy of routine continuation of DOACs for reducing pocket hematomas is not superior to one of interrupted DOAC use in the periprocedural period among patients with a high CHA2DS2-VASc score undergoing an EP procedure.

Description:

The goal of the trial was to assess the safety of performing electrophysiology (EP) device procedures without interrupting direct oral anticoagulant (DOAC) use.


Study Design

Patients scheduled for an EP device procedure were randomized in a 1:1 fashion to either continuing their DOACs interrupted during the periprocedural period (n = 328) or interrupted DOAC use (n = 334). Patients in the continued DOAC arm took the DOAC morning dose prior to the procedure. In the interrupted arm, DOAC was discontinued 2 days prior for patients on apixaban or rivaroxaban, and based on glomerular filtration rate for dabigatran. All three drugs were resumed at their usual dose ≥24 hours after the procedure.  

Inclusion criteria:

  • Undergoing EP procedure
  • CHA2DS2-VASc score ≥2
  • Treated with apixaban, rivaroxaban, or dabigatran
  • Total number of enrollees: 662
  • Duration of follow-up: duration of hospitalization
  • Mean patient age: 74 years
  • Percentage female: 28%
  • Prior stroke: 10%
  • CHA2DS2-VASc score: 3.9
  • Other medications: aspirin: 17%
  • Type of procedure: new permanent pacemaker: 65%, new implantable cardioverter-defibrillator: 30%

Principal Findings:

The primary outcome, clinically significant hematoma, for continued vs. uninterrupted DOAC use: 2.1% vs. 2.1%, p = 0.97. The trial was terminated early due to futility.

  • Hematoma requiring prolonged hospitalization: 0.3% vs. 0.6%, p = 1.0
  • Hematoma requiring interruption of anticoagulation: 2.1% vs. 2.1%, p = 0.97
  • Hematoma requiring reoperation: 0.6% vs. 0.3%, p = 0.62

Secondary outcomes for continued vs. uninterrupted DOAC use:

  • Any hematoma: 5.5% vs. 4.8%, p = 0.68
  • Significant pericardial effusion or cardiac tamponade: 0.3% vs. 0.3%
  • Stroke: 0.3% vs. 0.3%, p = 1.0

Interpretation:

The results of this trial indicate that a strategy of routine continuation of DOACs for reducing pocket hematomas is not superior to one of interrupted DOAC use in the periprocedural period among patients with a high CHA2DS2-VASc score who are on a DOAC and undergoing an EP procedure. The trial was terminated early due to futility; it was powered for an event rate of 16% in the control arm, while the observed rate was only 2.1%. In the BRUISE CONTROL-1 trial, uninterrupted warfarin use was noted to be superior to interrupted warfarin followed by heparin bridge in a similar clinical scenario.

Of note, the treating physicians were not blinded to randomization and this knowledge could have modified their implantation practices. For instance, the use of a prohemostatic agent was higher in the continued DOAC arm. 

References:

Presented by Dr. David H. Birnie at the American Heart Association Annual Scientific Sessions (AHA 2017), Anaheim, CA, November 12, 2017.


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