Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISECONTROL2)

University of Ottawa Heart Institute

Status and phase: Completed; Phase 3

Conditions: Hematoma

Treatments: Drug: Rivaroxaban; Drug: Dabigatran; Drug: Apixaban

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01675076

UOHI-05

Details and patient eligibility

About

The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

Full description

This is a prospective, open-label, randomized trial, with 1:1 randomization to either continued NOAC or interrupted NOAC in patients with non-rheumatic atrial fibrillation or atrial flutter and at moderate to high risk of arterial thrombo-embolic events who require device surgery.

All patients in the study will be receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment. The peri-operative management of the NOAC the patient is receiving is randomized to Interrupted NOAC or Continued NOAC.

Interrupted NOAC arm:

1. Interrupted Dabigatran

   • based on renal function, patients will discontinue Dabigatran 1 day before surgery if GFR > 50 mL/min, and 2 days before surgery if GFR is 30-50 mL/min.
   • Dabigatran will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

2. Interrupted Rivaroxaban

   • patients will discontinue Rivaroxaban 1 full day before surgery.
   • Rivaroxaban will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

3. Interrupted Apixaban

   • patients will discontinue Apixaban 1 full day before surgery.
   • Apixaban will be resumed at the next regular dose time, > or = 24 hours after the end of surgery.

Continued NOAC arm:

-patients will continue their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout.

All patients will have a baseline clinical lab test of serum creatinine or GRF measured.

Patients will be seen post-op on the day of their surgery for assessment of the surgical site and each day throughout their hospital stay by a blinded member of the research team. A telephone follow-up will be done on day 3-4 post surgery by an unblinded team member. All patients are seen 1-2 weeks post-op at their first routine post-op device clinic visit, for surgical site assessment by the blinded assessor and to complete Quality of Life questionnaires. Patients will be seen for assessment in the case of any bleeding or development of pocket swelling or hematoma. Patients developing a hematoma will be followed until resolution of the hematoma.

Enrollment: 663 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any patient undergoing device surgery (ie. de novo device implant or pulse generator change or lead replacement or pocket revision)
• receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to enrollment
• non-rheumatic atrial fibrillation and/or atrial flutter at moderate or high risk of ATE defined as: i) CHA2DS2VASc score greater than or equal to 2 OR ii) CHA2DS2VASc score < 2 with plan for cardioversion or defibrillation threshold testing at time of device surgery

Exclusion criteria

• unable or unwilling to provide informed consent
• history of noncompliance of medical therapy
• active device infection
• eGFR < 30 mL/min
• contraindication to NOAC
• rheumatic valvular disease with hemodynamically significant valve lesion
• mechanical heart valve

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

663 participants in 2 patient groups

Continued NOAC

Experimental group

Description:

- Patients continue on their chronic dose of Dabigatran or Rivaroxaban or Apixaban throughout

Treatment:

Drug: Apixaban

Drug: Rivaroxaban

Drug: Dabigatran

Interrupted NOAC

Active Comparator group

Description:

Interrupted Dabigatran: * Discontinue Dabigatran 1 day before surgery if GFR \> 50 mL/min or discontinue 2 days before surgery if GFR 30-50 mL/min * Resume Dabigatran at next regular dose timing \>or = 24 hours after the end of surgery Interrupted Rivaroxaban: * Discontinue Rivaroxaban 1 full day before surgery * Resume Rivaroxaban at next regular dose timing \>or = 24 hours after the end of surgery Interrupted Apixaban: * Discontinue Apixaban 1 full day before surgery * Resume Apixaban at next regular dose timing \>or = 24 hours after the end of surgery

Treatment:

Drug: Apixaban

Drug: Rivaroxaban

Drug: Dabigatran