Table 35Fondaparinux vs LMWH - Quality assessment

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
All cause mortality281RCTNo serious limitationsNo serious inconsistencySerious indirectness(a)Serious imprecision(b)
VTE related mortality281RCTNo serious limitationsNo serious inconsistencySerious indirectness(a)Serious imprecision(b)
Recurrent VTE rates281RCTNo serious limitationsNo serious inconsistencySerious indirectness(a)Serious imprecision(b)
Major bleeding281RCTNo serious limitationsNo serious inconsistencySerious indirectness(a)Serious imprecision(b)
Fatal bleeding281RCTNo serious limitationsNo serious inconsistencySerious indirectness(a)Very serious imprecision(c)
Intracranial bleeding/haemorrh age0----
Quality of Life0-----
PTS0-----
a

The dose used for the comparator (LMWH) is higher than the UK licensed dose, this may favour fondaparinux for bleeding outcomes and LMWH for efficacy outcomes. In addition, there is no direct comparison between fondaparinux and LMWH for patients who presented with PE.

b

The 95% CI crosses MID.

c

Very wide 95% CI crossing both MIDs, the data were very sparse.

From: 7, Pharmacological interventions

Cover of Venous Thromboembolic Diseases
Venous Thromboembolic Diseases: The Management of Venous Thromboembolic Diseases and the Role of Thrombophilia Testing [Internet].
NICE Clinical Guidelines, No. 144.
National Clinical Guideline Centre (UK).
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