Abstract 10001: Safety and Efficacy of Once Daily 220 mg Dabigatran Etexilate in a Real-World NonInterventional Study of More Than 5000 Patients After Total Knee or Hip Replacement
Introduction: Dabigatran etexilate (DE) 220 mg once daily (qd) was shown to be as effective as 40 mg enoxaparin qd in preventing venous thromboembolism (VTE) following total hip or knee replacement (THR, TKR), with a favorable safety profile. The aim of this international, observational study was to evaluate the safety and efficacy of DE in a real-world clinical setting, including patients at increased risk of bleeding and/or VTE.
Methods: Inclusion criteria stated that patients should be aged ≥ 18 years, undergoing elective THR or TKR, and eligible for DE 220 mg qd (first dose 110 mg 1-4 h after surgery) according to the European label for primary VTE prevention in patients undergoing THR and TKR surgery. The primary safety endpoint was the incidence of major bleeding events (MBEs) as defined in the DE Phase III trials. The primary efficacy endpoint was the composite incidence of symptomatic VTE (sVTE; proximal and distal deep vein thrombosis and nonfatal pulmonary embolism) and all-cause mortality.
Results: Of the 5292 patients treated, approximately 40% had ≥ 1 potential risk factor for increased bleeding and/or VTE, analyzed as predefined in the protocol. The most common were chronic use of NSAIDs, active smokers, concomitant ASA use, and coronary artery disease. The overall incidence of MBEs was 0.72% (95% CI 0.51%, 0.98%). None of the potential risk factors (those listed above, chronic heart failure and history of VTE) had a significant effect on the occurrence of MBEs based on logistic regression analyses at a 5% level. Major extra-surgical site bleeding occurred in 0.32% (95% CI 0.19%, 0.51%) of patients. The incidence of any bleeding event was 3.82% (95% CI 3.32%, 4.37%). The incidence of sVTE and all-cause mortality was 1.04% (95% CI 0.78%, 1.35%). This was more frequent in patients with a history of VTE than in those without (OR 5.59; 95% CI 2.53, 11.08). All of the other potential risk factors evaluated had little impact on the primary efficacy endpoint.
Conclusion: Dabigatran etexilate administered to patients undergoing THR or TKR following the recommendations of the European label was well tolerated with a good safety profile in a routine clinical setting. These real-world results are reassuring and supportive of the evidence seen in the clinical trials.
- © 2012 by American Heart Association, Inc.