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Outcomes comparable for aspirin vs. heparin combination therapy after Fontan procedure
Monagle P. J Am Coll Cardiol. 2011;58:645-651.
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Primary thromboprophylaxis with aspirin compared with combined heparin plus warfarin therapy after Fontan procedure produced similar outcomes in the first 2 years, results from an international, randomized trial showed.
The trial was conducted at six institutions between 1998 and 2003 and involved 111 patients who after the Fontan procedure were randomly assigned to aspirin (n=57) or warfarin (Coumadin, Bristol-Myers Squibb) within a 24-hour heparin lead-in (n=54). Echocardiograms were attained 3 months and 2 years after surgery.
Overall, baseline characteristics were similar between groups. Adverse events, including major bleeding and death, were few and did not substantially differ between groups. Likewise, occurrence of thrombosis during the study, the primary endpoint, was similar, with a slightly higher incidence reported in the heparin/warfarin group (13 vs. 12).
On further analysis, the rate of patients who had a thrombosis event at 2 years was 19%, with a nonsignificantly higher rate witnessed in the combination therapy group (24% vs. 14%; P=.45).
“(This study) contributes to the assumption that warfarin therapy imposes a considerable burden on children, including the need for regular blood tests and potentially lifestyle restrictions (for example, limitations on sporting activities) to minimize the risk of trauma-induced bleeding,” the researchers wrote.
Although assessing the quality of life of patients randomly assigned to warfarin compared with aspirin went beyond the scope of this study, they said it would be particularly useful, given the lack of difference in thrombosis prevention between the two treatment regimens.
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