Dabigatran (Pradaxa) is safe for extended venous thromboembolism prophylaxis after pancreatic oncologic surgery

Abstract

Background: Patients undergoing oncologic surgery are at increased risk of venous thromboembolism (VTE). The American College of Chest Physicians and AHPBA recommend low molecular weight heparin for 28 days postoperatively. Injectable anticoagulants are incommodious, and warfarin dosing is inconsistent after gastrointestinal surgery. Oral dabigatran (Pradaxa) is FDA approved for VTE prophylaxis after orthopedic surgery, uses fixed dosing and has an effective reversal agent. Methods: All patients undergoing pancreatic surgery for cancer between Jan and July 2017 were prescribed dabigatran (220 mg daily) from discharge to POD28. Patients were excluded if medically contraindicated. LMWH was prescribed when dabigatran was non-formulary, and other target specific oral anticoagulants were resumed if taken pre-operatively. The primary endpoint was bleeding complications through 90 days. Results: 85 patients were considered for extended VTE prophylaxis. The majority had pancreatic (78%) or ampullary (9%) adenocarcinoma. 74% underwent Whipple, and 21% venous reconstruction. 80 (94%) received extended prophylaxis starting on median POD 7 (IQR: 5,10): 2 refused and contraindications excluded 3 patients. 85% received dabigatran, 11% LMWH, and 4% oral Xa inhibitors. 2 patients (3%) had bleeding complications, both originally having arterial procedures (Clavien IVa & V). An additional 31 HPB oncology patients received dabigatran at provider discretion: 1 suffered a gastrointestinal bleed (Clavien II) on atrial fibrillation dosing. During the period, 2 developed symptomatic VTE prior to discharge on LMWH. Conclusion: Preliminary results show dabigatran to be a safe alternative for extended VTE prophylaxis with regard to bleeding complications. Investigation of relative efficacy is necessary. We cannot currently support dabigatran in patients undergoing arterial reconstruction.