OASIS 5 Trial shows fondaparinux may be an effective anti-thrombotic drug in many patients with acute coronary syndrome already on aspirin and clopidogrel

The OASIS 5 Trial suggests that fondaparinux may be at least as effective as an anti-thrombotic drug as enoxaparin for many patients with acute coronary syndrome already on aspirin and clopidogrel, according to a presentation at the annual meeting of the European Society of Cardiology.

The Organization to Assess Strategies for Ischaemic Syndromes (OASIS 5) trial is the largest to date to study therapies for patients with acute coronary syndrome and enrolled more than 20,000 patients. In the comparison of fondaparinux and enoxaparin as add-on therapy to aspirin and clopidogrel, the drugs were equally effective for the primary composite endpoint of preventing death, myocardial infarction, and refractory ischemia at 9 days (incidence of 5.9 and 5.8 percent, respectively). Participants had at least one of the three components of the primary endpoint.

Fondaparinux is the first in a new class of anti-thrombotics that selectively inhibit Factor Xa, a central protein in the coagulation process. In the treatment of thrombosis, Factor Xa plays a central role in the generation of thrombin. Fondaparinux has a proven safety profile with no reported cases of heparin-induced thrombocytopenia, a common and potentially fatal side effect of heparin.

In terms of side effects observed in the study, fondaparinux was associated with a 47-percent reduction in major bleeding compared with enoxaparin (2.1 and 4.0 percent incidence, respectively). Mortality rates at one month were 17-percent lower in the fondaparinux group (2.9 versus 3.5 percent). This difference in mortality rates was maintained at six months post therapy (5.8 percent for fondaparinux and 6.6 percent for enoxaparin), representing an 11-percent reduction in mortality.

"The OASIS 5 findings demonstrate that fondaparinux is likely an effective anti-thrombotic drug in many patients with acute coronary syndrome already receiving aspirin and clopidogrel," said Dr. Salim Yusuf, principal investigator of the study, and professor of medicine, McMaster University and Hamilton Heath Sciences, Ontario, Canada.


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