Rivaroxaban for the treatment of deep vein thrombosis and ...

Haemophilia and other severe bleeding disorders
Previous heparin induced thrombocytopenia
Low platelet count for any reason
Active bleeding
Recent peptic ulcer
Recent intracerebral bleeding
Severe uncontrolled hypertension
Major trauma or recent major surgery to eye or central nervous system
Bacterial endocarditis
Spinal or epidural catheter
The EINSTEIN-DVT exclusion criteria exclude patients at high risk of bleeding, and it is therefore
likely that all of the above were excluded from the trial. The ERG does not feel that the cancer group
would necessarily serve as a proxy for other patients in this group, as rivaroxaban may act differently
in some of these patient groups, e.g. renal failure. Therefore, no evidence for the use of rivaroxaban
versus LMWH is available.
3.3.6 Comparator time in treatment range and compliance– EINSTEIN-DVT
Levels of compliance and time in treatment range for VKA treatment are thought to affect levels of
effectiveness. The levels achieved in the comparator arm in the study are fairly representative of UK
practice; time in target range (TTR) was 57.7% across all centres and 59.7% in Western European
centres (page 88). This compares well with a reported UK TTR of 53% during the first 12 weeks of
treatment and 59% thereafter. 27 However, the clinical advisors to the ERG feel that whilst this is
representative, it is also a worryingly low figure, and there is general concern about the levels of
anticoagulation achieved within the UK. It is thought that there is room for improving these figures,
and were resources used to this end, better levels of anticoagulation may be possible, and better
efficacy may be achieved for LMWH/VKA treatment.
27
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