BRIDGE (atrial fibrillation)
Trial question
Is forgoing bridging anticoagulation noninferior to perioperative bridging in patients with AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 1884
1884 patients (502 female, 1382 male).
Inclusion criteria: patients with AF who need an interruption in warfarin treatment (5 days before the procedure) for an elective operation or other elective invasive procedure.
Key exclusion criteria: a mechanical heart valve; stroke, systemic embolism, or TIA within the previous 12 weeks; major bleeding within the previous 6 weeks; CrCl of < 30 mL/min; platelet count of < 100×10⁹/L, or planned cardiac, intracranial, or intraspinal surgery.
Interventions
N=950 avoiding routine bridging (matching subcutaneous placebo BID).
N=934 routine bridging therapy (100 IU dalteparin per kg of body weight administered SC BID from 3 days before the procedure until 24h before the procedure and then 5-10 days after the procedure).
Primary outcome
Arterial thromboembolism at 30 days after procedure
0.4%
0.3%
0.4 %
0.3 %
0.2 %
0.1 %
0.0 %
Avoiding routine
bridging
Routine bridging
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in arterial thromboembolism at 30 days after the procedure (0.4% vs. 0.3%; AD 0.1%, 95% CI -0.6 to 0.8).
Secondary outcomes
No significant difference in death (0.5% vs. 0.4%; AD 0.1%, 95% CI -1.1 to 1.3).
No significant difference in MI (0.8% vs. 1.6%; ARD -0.8, 95% CI -1.75 to 0.15).
No significant difference in DVT (0% vs. 0.1%; ARD -0.1, 95% CI -0.27 to 0.07).
Safety outcomes
Significant differences in major bleeding (1.3% vs. 3.2%), minor bleeding (12.0% vs. 20.9%).
Conclusion
In patients with AF who need an interruption in warfarin treatment (5 days before the procedure) for an elective operation or other elective invasive procedure, avoiding routine bridging was noninferior to routine bridging therapy with respect to arterial thromboembolism at 30 days after the procedure.
Reference
Douketis JD, Spyropoulos AC, Kaatz S et al. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33.
Open reference URL