SAFETY OF ENOXAPARIN AND DEXTRAN-70 IN THE PREVENTION OF VENOUS THROMBOEMBOLISM IN DIGESTIVE SURGERY - A PLAY-THE-WINNER-DESIGNED STUDY

A total of 327 patients were included in a play-the-winner (PTW)-designed study comparing the safety of prophylaxis with enoxaparin and dextran-70 in patients undergoing digestive surgery. In a PTW-designed study the treatment of any next patient will depend on the outcome of the previous one. If successful, the next patient will receive the same treatment. Excessive bleeding, on the basis of specified criteria, severe adverse effects, or occurrence of clinically detected venous thromboembolism was classified as failure. The PTW design allocates most patients to the superior treatment. In this study 200 patients were given enoxaparin and 127 dextran-70. The success rate was 83% in the enoxaparin group and 74.8% in the dextran-70 group (p = 0.05). The survival analysis of 'Number of patients before change in treatment' shows a significant difference in favour of enoxaparin (p = 0.05). Enoxaparin seems to be superior to dextran-70 as a prophylaxis in digestive surgery. The PTW model is a suitable design in such studies.