Strategy of Continued Versus Interrupted Dabigatran at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISECONTROL2)

• Clinically significant hematoma [ Time Frame: 2 weeks post-op or until resolution of hematoma ] [ Designated as safety issue: Yes ]

  Defined as:

  1. Hematoma requiring re-operation

     - Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome.

     or

  2. Hematoma resulting in prolongation of hospitalization

     - Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma.

     or

  3. Hematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation, in response to wound hematoma.
  
  

• Composite of major peri-operative bleeding events and thrombo-embolic events [ Time Frame: 2 weeks post-op ] [ Designated as safety issue: Yes ]
  1. Each of the components of the primary outcome

  2. Composite of all other major peri-operative bleeding events defined as:

     • hemothorax
     • cardiac tamponade
     • significant pericardial effusion

  3. Thrombo-embolic events defined as:

     • transient ischemic attack
     • stroke
     • deep venous thrombosis
     • pulmonary embolism
     • peripheral embolus to limb
     • peripheral embolus to other major organ
  4. All cause mortality
  5. Cost utilization
  6. Patient quality of life and peri-operative pain, and satisfaction
  
  

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

All patients in the study will be treated with Dabigatran for at least 5 days prior to surgery. Regardless of the chronic dose, all patients will receive Dabigatran 110 mg BID for 5 days prior to device surgery and for the 5 days following surgery. The peri-operative management of Dabigatran 110 mg BID is randomized to the following:

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, at least 24 hours after the end of surgery.

2. Continued Dabigatran

   • patients will continue on Dabigatran 110 mg BID throughout
   • patients will have an aPTT measured at trough (within 2 hours prior to next dose)once within 5 days prior to the surgery. If the aPTT is > 2.5 times the upper limit of normal, the dose of Dabigatran will be held on the morning of surgery.

All patients will have clinical lab testing of serum creatinine, CBC, INR, aPTT, thrombin clotting time (TCT) and Hemoclot test on the day of surgery.

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.