population seems to be questionable. The lack
of obvious benefits supports the need for
randomised trials in this setting as well as in
patients with sRI, ESRD/CHD and acute VTE.
In this context, it should be noted that embolism
in AF is a permanent risk, whereas the risk of
recurrent VTE decreases with time from the
initial event. Thus, a transfer of study results in
patients with AF to those with VTE needs critical
reflection.
A retrospective analysis following 1509
patients with VTE and sRI for three years
demonstrated higher risks for relapse, major
bleedings and mortality. 18 The available data
comparing the initial anticoagulation in sRI
or ESRD patients with acute VTE did not
demonstrate any benefit for UFH compared with
LMWH with regard to efficacy or safety but hint
at an increased mortality in patients with sRI
treated with UFH compared with LMWH. 19
Nevertheless, prospective randomised clinical
trials are still unavailable. Until direct evidence
is available, highly individual clinical decision-
making must be recommended, especially with
regard to the duration of full-dose anticoagulation
therapy, because treatment efficacy in most
patients suffering from acute VTE can be
monitored by clinical, technical (ultrasound)
and laboratory (D-dimer) investigations. Thus,
a tailored duration and intensity of
anticoagulation can be determined, thereby
limiting the risk of haemorrhage due to
prolonged anticoagulation.
The availability of DOACs provides an
alternative oral anticoagulation solution. 6 Again,
subjects with sRI were excluded in the pitoval
trials in VTE (and AF) with the thrombin inhibitor
dabigatran (GFR <30ml/min) and the factor Xa
inhibitors apixaban (GFR <25ml/min), edoxaban
(GFR <30ml/min) or rivaroxaban (GFR <30ml/
min). 4-6
Based on published investigations of
pharmacokinetics in patients with CHD, dose
recommendations have been issued for ESRD. 20
For apixaban, the regular 5mg twice daily dose
(2.5mg twice daily in patients > 80 years or <
60kg body weight) is suggested. Concerning
rivaroxaban, a daily dose of 10mg in CHD patients
resulted in drug exposure parameters similar to
the findings for 20mg once a day in healthy
volunteers. For edoxaban, a 15mg dose once daily
in ESKD patients was found to be equivalent to
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