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 Pregnancy in Autoimmune DiseaseAbstract 1347: Results of the HepASA Trial: Low Moleculare Weight Heparin + ASA vs ASA Only for Recurrent Pregnancy LossAuthors: Carl A. Laskin1, Jeff Ginsberg2, Mark Crowther2, Michael Gent2, John C. Kingdom3, Chrisitine A. Clark4, Karen A. Spitzer4, Jon FR Barrett4. 1University of Toronto, LifeQuest Centre for Reproductive Medicine, Toronto, ON, Canada; 2McMaster University Medical Centre, Hamilton, ON, Canada; 3Mount Sinai Hosptial, University of Toronto, Toronto, ON, Canada; 4University of Toronto, Toronto, ON, Canada The TERM Program (Treatment and Evaluation of Recurrent Miscarriage) at the University of Toronto randomized women with a history of recurrent miscarriages to two treatment groups: (1) 5000 IU daily of dalteparin (low molecular weight heparin) and low-dose aspirin (HepASA) or (2) low-dose aspirin alone (ASA). A patient was eligible if she had had at least 2 consecutive 1st trimester pregnancy losses or at least 1 loss in the 2nd or 3rd trimesters; had normal genetic testing for both parents; and had at least one positive blood test on 2 occasions (ANA, anti-dsDNA, anti-cardiolipin antibody, lupus anticoagulant, or thrombophilia screen) The TERM Program screened 859 women for participation in the trial. They had anticipated enrolling 200 women in the trial, to allow the ability to identify a 20% difference in pregnancy loss rates between the treatment groups. However, after 4 years, they were only able to enroll 88 women. The authors attribute much of the difficulty in enrollment on the lack of positive blood tests in the referred patients. Results:
(No statistically significant differences between any groups) Conclusion: This study found NO BENEFIT in the live birth rate with heparin therapy for women with recurrent miscarriage at risk for thrombosis. Editorial: The current gold-standard therapy for women with Antiphospholipid Syndrome (APS) during pregnancy is low-molecular weight heparin (LMWH) and low-dose aspirin. Several randomized trials have shown a significant improvement in pregnancy outcomes with this therapy, but one trial failed to show benefit. In all studies of this combination therapy, the success rate of treatment is between 70-80%. In the studies that show benefit, the success rate of aspirin alone is between 40-50%, while in the studies (including this one) that show no benefit, the success rate of aspirin alone is between 70-80%. It is unclear why some studies have poor success with aspirin alone and others do not. I doubt that the widespread use of LMWH plus aspirin will change based on this study. However, as the paradigm of the pathogenesis of APS pregnancy loss begins to shift from thrombotic to inflammatory, this study may be a stepping stone to a shift in therapeutic strategy. | |||||||||||||||||||||||||||||||