We agree that the benefits of new antithrombotic agents must be weighed against their associated risks. In the fondaparinux trials, the difference in major bleeding observed between the 2 groups was mainly accounted for by an excess of "overt bleeding with a bleeding index of 2 or more."1 The clinical relevance of the bleeding index is uncertain. In our trials, the difference in the bleeding index between the fondaparinux and enoxaparin groups was not reflected by a difference in fatal bleeding, critical organ bleeding, bleeding leading to reoperation, and wound infection or complications at the surgical site leading to prolonged hospitalization or rehospitalization. It is noteworthy that when the first injection of fondaparinux was given between 6 and 8 hours after skin closure, as recommended in the US package insert, the rate of major bleeding decreased to 1.9%, a rate comparable with that observed with enoxaparin use (1.9%).
Turpie AGG, Bauer KA, Eriksson BI, Lassen MR. Clinical Relevance of Bleeding Index—Reply. Arch Intern Med. 2003;163(22):2794-2795. doi:10.1001/archinte.163.22.2794-a