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January 1, 2017Thrombosis and Haemostasis

Dabigatran versus Warfarin for Acute Venous Thromboembolism in Elderly or Impaired Renal Function Patients: Pooled Analysis of RE-COVER and RE-COVER II

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Key result

Dabigatran showed better efficacy than warfarin for preventing recurrent VTE in patients with moderate renal impairment (0.0% vs 4.1%) and the elderly, though bleeding risk increased with both.

Why the study?

Does dabigatran improve efficacy and safety compared to warfarin in elderly patients or those with impaired renal function with acute venous thromboembolism?

Population

5,107 patients with acute venous thromboembolism, including 4,504 aged <75 years and 603 aged ≥75 years…

Comparison

Dabigatran 150 mg twice daily vs Warfarin

Design

Meta-analysis

Follow-up

6 months

Authors

SGSamuel Z. GoldhaberSSSam SchulmanHEHenry Eriksson

Discussion

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Overview

Supports dabigatran over warfarin for recurrent VTE prevention in moderate renal impairment and elderly; extends pooled RCT evidence to these subgroups.

Key Points

  • This analysis aims to evaluate the effects of age and renal impairment on the efficacy and safety of dabigatran and warfarin in managing acute venous thromboembolism.
  • Pooled analysis of RE-COVER and RE-COVER II trials involving 5,107 patients with varying renal functions.
  • Comparison of symptomatic VTE/VTE-related death rates and bleeding events between dabigatran and warfarin treatments.
  • Renal function categorized into normal, mild renal impairment, and moderate renal impairment.
  • Dabigatran showed a decrease in VTE/VTE-related death from 3.1% (normal renal) to 1.9% (mild RI) and 0.0% (moderate RI).
  • Warfarin reported event rates of 2.6%, 1.6%, and 4.1% respectively for the same renal categories.
  • Major bleeding increased with renal impairment (p=0.0037) despite no significant difference in bleeding risk between treatments.

Study Design

Type

Meta-Analysis (n=5,107)

Structured PICO

Does dabigatran improve efficacy and safety compared to warfarin in elderly patients or those with impaired renal function with acute venous thromboembolism?

P
Population
5,107 patients with acute venous thromboembolism from the RE-COVER and RE-COVER II trials, evaluated over 6 months to assess the effects of age and renal impairment on outcomes.
I
Intervention
Dabigatran 150 mg twice daily
C
Comparator
Warfarin
O
Outcome
Symptomatic VTE/VTE-related deathcomposite

Dabigatran appears more effective than warfarin in preventing recurrent VTE in elderly patients and those with moderate renal impairment, though bleeding risk increases with renal impairment for both drugs.

Cite This Study

Goldhaber et al. (2017) conducted a meta-analysis in Acute venous thromboembolism (n=5,107). Dabigatran vs. Warfarin was evaluated on Symptomatic VTE/VTE-related death. Dabigatran showed better efficacy than warfarin for preventing recurrent VTE in patients with moderate renal impairment (0.0% vs 4.1%) and the elderly, though bleeding risk increased with both.

synapsesocial.com/papers/6a581fa24075ee146068d87fhttps://doi.org/10.1160/th17-03-0176
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Bleeding events with dabigatran or warfarin in patients with venous thromboembolism2015 · 26 citations
  2. 2Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation2013 · 397 citations
  3. 3Dabigatran use in elderly patients with atrial fibrillation2015 · 95 citations
  4. 4Effects of dabigatran according to age in atrial fibrillation2017 · 89 citations
  5. 5Profile of patients diagnosed with acute venous thromboembolism in routine practice according to age and renal function: RE-COVERY DVT/PE study2020 · 4 citations