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Several recent studies have examined the impact of rivaroxaban and other factor Xa inhibitors in the prevention of thrombosis related to pulmonary embolism, stroke and acute coronary syndromes. Controversy exists surrounding the utility of incorporating rivaroxaban as adjunctive therapy in patients with acute coronary syndromes. We sought to examine the impact of this therapy by performing a Bayesian net clinical benefit analysis with respect to primary and secondary efficacy and safety endpoints.
: Using reported information from the ATLAS-ACS TIMI-52 study, we obtained data regarding primary combined endpoint, as well as MI, stroke, mortality, stent thrombosis and bleeding. Using this information, an aggregate Bayesian analysis was performed, and probabilities of benefit, along with magnitude of therapeutic effect were calculated. Net clinical benefit was derived from overall combined efficacy endpoints and safety endpoints. Delineation was made between rivaroxaban 2.5mg and 5mg doses.
Posterior probabilities for the primary endpoint indicated a probability of benefit of 87.3% for both dosages. Both doses had similar efficacy versus placebo with respect to stent thrombosis. However, the 2.5mg dose appears have differential benefit with regards to cardiac mortality and all-cause mortality, along with slightly lower bleeding. The net clinical benefit calculation indicates a 63.2% benefit for the 2.5mg dose, and a 52.7% benefit for the 5mg dose over placebo.
Though the results from the primary endpoint in ATLAS TIMI 52 met the primary endpoint, when combined with increase in bleeding risk in a net clinical benefit calculation, both 5mg and 2.5mg doses appear to perform only slightly better than placebo. This difference is mediated by a significant benefit in terms of cardiac mortality, especially with the 2.5mg dose, coupled with a significant increase in bleeding risk, especially with the 5mg dose.
Poster Sessions, Expo North
Sunday, March 10, 2013, 9:45 a.m.-10:30 a.m.
Session Title: AMI and PCI II
Abstract Category: 28. Quality of Care and Outcomes Assessment
Presentation Number: 1199-96
- 2013 American College of Cardiology Foundation