Effectiveness of dabigatran etexilate for thromboprophylaxis of mechanical heart valves

Autor: Mark H. Ereth, Christopher L. Camp, Stuart A. Abel, Stephen H. McKellar, Rakesh M. Suri, Hartzell V. Schaff
Rok vydání: 2011
Předmět:
Zdroj: The Journal of Thoracic and Cardiovascular Surgery. 141(6):1410-1416
ISSN: 0022-5223
DOI: 10.1016/j.jtcvs.2011.02.011
Popis: Objective: Warfarin reduces risk of stroke in patients with mechanical heart valves but increases risk of hemorrhage and is difficult to use. Dabigatran etexilate, a new oral direct thrombin inhibitor, is safe and effective in reducing risk of stroke among patients with atrial fibrillation. No data exist in the setting of mechanical heart valves. We tested the hypothesis that dabigatran etexilate is as effective as heparin for thromboprophylaxis of mechanical valves in a porcine heterotopic aortic valve model. Methods: Thirty swine underwent implantation of modified bileaflet mechanical valved conduit bypassing the ligated, native descending thoracic aorta. Animals randomly received no anticoagulation (n ¼ 10), enoxaparin 2 mg/kg subcutaneously twice daily (n ¼ 10), or dabigatran etexilate 20 mg/kg orally twice daily. Primary end point was amount of valve thrombus at 30 days. Secondary end points included quantitative measurement of platelet deposition on valve prosthesis, thromboelastography, and hemorrhagic and embolic events. Results: At 30 days, we observed 638 � 895 mg thrombus in no anticoagulation group, 121 � 128 mg in enoxaparin group, and 19 � 31 mg in dabigatran etexilate group (P ¼ .01 enoxaparin vs dabigatran etexilate). Fewer plateletsweredeposited onvalvesin dabigatran etexilategroup (2.7310 8 ) than in enoxaparin group (1.8310 9 , P ¼ .03). No major or occult hemorrhagic or embolic events were observed. By thromboelastographic analysis, dabigatran etexilate produced less prolongation of K value (P ¼ .01) and less decreases in angle (P ¼ .01) and maximum amplitude (P ¼ .001) than enoxaparin. Conclusions: Dabigatran etexilate is as effective as enoxaparin for short-term thromboprophylaxis of mechanicalvalves.Itpreventsvalvethrombusandplateletdepositionat30dayswithoutincreasedadverseevents.These promisingresults serveasafoundation forprospectiveclinical trialswithdabigatran etexilate asan alternativeto warfarin in patients with bileaflet mechanical aortic valves. (J Thorac Cardiovasc Surg 2011;141:1410-6)
Databáze: OpenAIRE