PMID- 16236875
OWN - NLM
STAT- MEDLINE
DCOM- 20051121
LR  - 20220318
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 128
IP  - 4
DP  - 2005 Oct
TI  - Enoxaparin in the treatment of deep vein thrombosis with or without pulmonary 
      embolism: an individual patient data meta-analysis.
PG  - 2203-10
AB  - STUDY OBJECTIVES: Low-molecular-weight heparins have been compared with 
      unfractionated heparin (UFH) for treatment of deep vein thrombosis (DVT). 
      However, a comparison of their efficacy in the presence or absence of pulmonary 
      embolism (PE) has not been studied. We estimated the efficacy and safety of 
      enoxaparin vs UFH in patients with proximal DVT with/without symptomatic PE using 
      a meta-analysis of individual data from randomized controlled trials. DESIGN AND 
      SETTING: Randomized controlled trials were identified from MEDLINE, EMBASE, 
      abstracts from international meetings on venous thromboembolism (VTE), previous 
      meta-analyses, and trial data provided by the sponsor. PARTICIPANTS: For 
      inclusion, randomized controlled trials had to be properly randomized; include 
      patients with objectively diagnosed DVT; compare enoxaparin twice daily with UFH; 
      use objective methods to assess recurrent symptomatic VTE, major bleeding, and 
      death at 3 months; and include blind evaluation of clinical events. MEASUREMENTS: 
      A meta-analysis was performed using the logarithm of the relative risk (RR) 
      method. Enoxaparin in DVT treatment with/without symptomatic PE was considered 
      noninferior to UFH for preventing VTE at 3 months if the upper limit of the 95% 
      confidence interval (CI) of the RR (enoxaparin/UFH) was lower than a prespecified 
      noninferiority margin (1.61). No increase in major bleeding or mortality should 
      be observed. RESULTS: The meta-analysis included individual data from three 
      randomized controlled trials (749 patients and 754 patients in the enoxaparin and 
      UFH groups, respectively). The observed RR (enoxaparin/UFH) of VTE was 0.81 (95% 
      CI, 0.52 to 1.26) for the intention-to-treat population (RR, 0.70; 95% CI, 0.43 
      to 1.13; for per-protocol analysis). Results did not differ for patients with 
      clinical PE (235 patients; RR, 0.84) and without clinical PE (1,268 patients; RR, 
      0.71), with a nonsignificant heterogeneity test between groups (p = 0.76). A 
      trend in favor of enoxaparin was observed for reduced mortality and major 
      bleeding. CONCLUSIONS: The efficacy and safety of enoxaparin vs UFH for DVT 
      treatment is not modified by the presence of symptomatic PE.
FAU - Mismetti, Patrick
AU  - Mismetti P
AD  - Thrombosis Research Group, Clinical Pharmacology Department, University Hospital 
      Bellevue, F-42055 Saint-Etienne, France.
FAU - Quenet, Sara
AU  - Quenet S
FAU - Levine, Mark
AU  - Levine M
FAU - Merli, Geno
AU  - Merli G
FAU - Decousus, Herve
AU  - Decousus H
FAU - Derobert, Eric
AU  - Derobert E
FAU - Laporte, Silvy
AU  - Laporte S
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 0 (Heparin, Low-Molecular-Weight)
SB  - IM
MH  - Anticoagulants/therapeutic use
MH  - Clinical Trials as Topic
MH  - Enoxaparin/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/therapeutic use
MH  - Humans
MH  - Pulmonary Embolism/*drug therapy/etiology
MH  - Randomized Controlled Trials as Topic
MH  - Recurrence
MH  - Reproducibility of Results
MH  - Risk
MH  - Thromboembolism/drug therapy
MH  - Venous Thrombosis/complications/*drug therapy
EDAT- 2005/10/21 09:00
MHDA- 2005/12/13 09:00
CRDT- 2005/10/21 09:00
PHST- 2005/10/21 09:00 [pubmed]
PHST- 2005/12/13 09:00 [medline]
PHST- 2005/10/21 09:00 [entrez]
AID - S0012-3692(15)52623-8 [pii]
AID - 10.1378/chest.128.4.2203 [doi]
PST - ppublish
SO  - Chest. 2005 Oct;128(4):2203-10. doi: 10.1378/chest.128.4.2203.