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Semin Thromb Hemost 2012; 38(01): 23-30
DOI: 10.1055/s-0031-1300948
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Active Online Assessment of Patients Using New Oral Anticoagulants: Bleeding Risk, Compliance, and Coagulation Analysis

Birgitta Salmela
1   Coagulation Disorders, Division of Hematology, Department of Internal Medicine, Helsinki University Central Hospital, Helsinki, Finland
,
Lotta Joutsi-Korhonen
2   Clinical Chemistry, HUSLAB Laboratory Services, Helsinki University Central Hospital, Helsinki, Finland
,
Elina Armstrong
1   Coagulation Disorders, Division of Hematology, Department of Internal Medicine, Helsinki University Central Hospital, Helsinki, Finland
,
Riitta Lassila
1   Coagulation Disorders, Division of Hematology, Department of Internal Medicine, Helsinki University Central Hospital, Helsinki, Finland
2   Clinical Chemistry, HUSLAB Laboratory Services, Helsinki University Central Hospital, Helsinki, Finland
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Publikationsdatum:
07. Februar 2012 (online)

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Abstract

Clinicians prescribing new oral anticoagulants (OACs; dabigatran, rivaroxaban, and apixaban) should be aware of the exclusion criteria related to bleeding risks defined in published clinical studies. At least a quarter of patients currently using warfarin have an exclusion criterion that may prevent easy transition to the new OACs. In the summary of product characteristics for dabigatran, as an example, the target populations appear generalized. Due to fixed dosing and predictable pharmacology, routine laboratory monitoring of new OACs is deemed unnecessary. Under special circumstances, however, understanding the extent of thrombin or factor (F) Xa inhibition may aid in evaluating compliance and handling emergency interventions, bleeding complications, or overdoses. Although commonly available global coagulation-time assessments (prothrombin time and activated partial thromboplastin time) are insensitive, they may assist clinical management by indicating a severe accumulation of OACs; moreover, a normal thrombin time (TT) excludes a thrombin-inhibitor effect. In particular circumstances, specific assays (diluted TT, Ecarin clotting time, anti-FIIa or anti-FXa activity) may quantify the anticoagulant effect, but therapeutic ranges for dose adjustment are not yet established. Laboratory results are also influenced by clinical situation: e.g. bleed (consumption of coagulation factors) versus postoperative state (activation of coagulation). Without specific antidotes and evidence-based treatment strategies, new OACs are clinically worrisome in patients with impaired renal or liver function. Postmarketing surveillance and recording of bleeding complications (ICD-10 D68.32) are therefore of major importance.

Keywords

bleeding risk - new oral anticoagulants - laboratory measuring - dabigatran - rivaroxaban - apixaban