Methods:

This was an observational study that included patients treated with dabigatran and planned for an invasive procedure. The timing of the last dose of dabigatran before the procedure was based on the creatinine clearance and procedure-related bleeding risk. Resumption of dabigatran was also prespecified and was determined by the complexity of the surgery and consequences of a bleeding complication. Patients were followed for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism, and death. High-risk surgeries included cardiac surgery, neurosurgery, abdominal surgery, or those involving a major organ or where complete hemostasis may be required. Other factors such as spinal anesthesia and other determinants of bleeding risk including advancing age, comorbidities (e.g., major cardiac, respiratory or liver disease), and concomitant use of antiplatelet therapy were also considered.