Copenhagen – A real-life comparison of major bleeding risk with anticoagulants showed that in-hospital mortality was lower with novel oral agents than with vitamin K antagonists, but the risk varied by bleeding site.
Novel oral anticoagulants (NOACs) such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) were associated in randomized phase III clinical trials with lower incidences of major bleeding than vitamin K antagonists (VKA) such as warfarin, and the newer, heavily advertised agents are widely used in clinical practice, noted Dr. Laura Franco of the Stroke Unit at the University of Perugia, Italy.
“But there is [little] information about the management and outcomes of major bleeding with NOACs in real life,” she said at a briefing at the annual congress of the European Hematology Association.
Neil Osterweil/Frontline Medical News
Dr. Laura Franco
To rectify this situation, Dr. Franco and her colleagues at nine Italian hospitals and the NOAC registry based in Dresden, Germany, looked at 30-day mortality and other outcomes among 874 consecutive patients admitted for a major bleeding episode from September 2013 through May 2016. In all, 220 of the patients were on NOACs, and 654 were on VKAs.
Intracranial bleeds occurred in 44% of all patients, but were significantly less common among patients on NOACs than on VKAs (22% vs, 52%, respectively, odds ratio 0.26, P less than .001), whereas gastrointestinal bleeds, which occurred in 30% of all patients, were more frequent with the newer oral agents than with the older VKAs (46% vs. 30%, OR 2.69, P less than .001).
Deaths within 30 days of emergency department admission were less frequent with NOACs (10% vs. 17%, hazard ratio 0.56, P = .012).
“But when we analyzed the subpopulation of patients with different sites of bleeding, we saw that among intracranial hemorrhage, the rate was equal among NOAC and VKAs patients, 25% in both groups,” Dr. Franco said.
Deaths from gastrointestinal bleeding were numerically lower among patients on NOACs (7% vs. 10%), but this difference was not statistically significant.
“The great advantages of the new oral anticoagulants are the reduced risk in intracranial hemorrhage, so we showed that the lower mortality is not due to an intrinsic capacity to reduce deaths by NOACs as compared to VKAs, but to a different pattern of bleeding sites,” Dr. Franco said.
The study funding source was not disclosed. Dr. Franco did not report relevant disclosures.