BRIDGE (2015) – Peri-Procedural Bridging Anticoagulation

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BRIDGE (2015) – Peri-Procedural Bridging Anticoagulation

Clinical question: in patients with atrial fibrillation, is peri-operative heparin bridging required during interruption of warfarin therapy?

Study design: randomized, double-blind placebo-controlled trial

Inclusion criteria:

  • Age ≥ 18
  • Permanent or paroxysmal atrial fibrillation / atrial flutter (confirmed by ECG / pacemaker interrogation), including valvular AF
  • On warfarin for ≥ 3 months with a target INR of 2 – 3
  • CHADS2 score ≥ 1 (congestive heart failure, hypertension, age > 75, diabetes, previous stroke)
  • Undergoing invasive procedure / surgery requiring interruption of warfarin therapy

Exclusion criteria:

  • Mechanical heart valve
  • Stroke, TIA or systemic embolism within the last 12 weeks
  • Major bleeding within the last 6 weeks
  • Creatinine clearance < 30ml/min
  • Platelet count < 100 x 109/L
  • Planned for cardiac, intracranial or intraspinal surgery
  • Heparin-induced thrombocytopaenia or heparin allergy
  • Multiple planned procedures

Intervention:

  • Patients randomized to bridging group or control group
  • Bridging group: delteparin 100 IU/kg BD three days pre and 5-10 days post-procedure
  • Control: subcutaneous placebo BD three days pre and 5-10 days post-procedure

Patient characteristics:

  • 1884 patients, 934 in bridging group and 950 in placebo group
  • Mean age 71.7 years
  • Mean CHADS2 score of 2.3
  • Approximately 40% on an antiplatelet, no difference in proportion of patients on antiplatelets

Outcomes and results:

  • All outcomes assessed at 37 days post-procedure
  • Primary outcomes at 30 days post-procedure:
    • Arterial thromboembolism – 0.4% in bridging, 0.3% in placebo (p = 0.01 for non-inferiority, p = 0.73 for superiority)
    • Major bleeding – 3.2% in bridging, 1.3% in placebo (p = 0.005 for superiority)
  • Secondary outcomes
    • Acute myocardial infarction – no difference
    • Deep vein thrombosis – no difference
    • Pulmonary embolism – no difference
    • Minor bleeding – 20.9% in bridging, 12.0% in placebo (p < 0.001 for superiority)

Limitations:

  • Use of CHADS2 vs CHADS2VASC2 score
  • Male preponderance (73.4%)
  • Mean CHADS2 score of 2.3, only 3% of patients with CHADS2 ≥ 5 (limited conclusions in high-risk patients)
  • Numbers of actual thromboembolism were lower than expected – target power of the study had to be lowered, hence reducing chance that superiority of bridging over placebo could be detected
  • Primary outcome of arterial thromboembolism assessed and defined by presence of clinical symptoms – smaller, sub-clinical events may have been missed

Conclusions:

  • In patients on warfarin for atrial fibrillation, placebo was non-inferior to delteparin for the prevention of arterial thromboembolism
  • Patients who are bridged peri-operatively with delteparin are at high risk of major bleeding

Reference: Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, et al. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015;373(9):823-33

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