The impact of bleeding complications in patients receiving target-specific oral anticoagulants: a systematic review and meta-analysis.

Chai-Adisaksopha C, Crowther M, Isayama T, Lim W
Blood 2014;124:2450-2458.
NATA Rating :
Review by : D. Faraoni
NATA Review

Oral anticoagulation is routinely used in different clinical settings with the aim to prevent or treat thromboembolic complications. Although the bleeding risk was already relevant with vitamin K antagonist (VKAs), there was a renewed interest in bleeding complications when new oral anticoagulants (NOACs) became increasingly used. The main reason is the lack of currently available specific or non-specific antidotes (with the exception of prothrombin complex concentrates) to reverse the anticoagulant effect of these NOACs.

In this article, the authors performed a huge systematic review with meta-analysis including over 100,000 patients treated with oral anticoagulants. This large meta-analysis reports that, compared with VKAs, NOACs are associated with a significant reduction in the incidence of major bleeding, fatal bleeding, intracranial bleeding, clinically relevant non-major bleeding, and total bleeding. Although these results appear reassuring, our attention should be drawn on a few points:
1) As already mentioned in previous comments, only limited ‘non-specific’ therapeutic approaches are currently available in case of bleeding associated with NOACs;
2) In a recent international survey evaluating physicians’ knowledge and practices regarding NOACs (Faraoni D et al. Clin Lab Med 2014;34:637-54), we observed a huge variability in physicians’ strategies for the management of NOACs-induced bleeding, reflecting a lack of familiarity with these drugs;
3) The results of this meta-analysis should be interpreted with caution, as this analysis only included patients that participated in one of the published studies, which means that physicians used a well-defined strategy for patient management. As a consequence, these results did not reflect the ‘true’ incidence of major and fatal bleeding that we could observe in the ‘real life’.

In conclusion, this meta-analysis gives us a reassuring message regarding the incidence of bleeding in patient treated with NOACs. In the future, these results should be compared with the incidence obtained from large ongoing registries.

– David Faraoni

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