Evidence Table 70Venal cava filters vs no filters

Bibliographic referenceStudy TypeEvidence levelNo. of patientsPatients characteristicsInterventionComparisonLength of follow upOutcome measuresEffect sizeComments
Decousus et al 1998154

Long term follow up at 8 years published by The PREPIC Study Group 636 (see next entry)
RCT1+Total: 400

Intervention : n = 200
Control: n = 200
Hospitalised patients: with proximal DVT considered to be at high risk for PE

Intervention: Mean age: 73±11 yrs
M/F:92/108

Control: Mean age: 72±11.5
M/F:98/102

Pre-existing risk factors: History of VTE, Chronic cardiac or respiratory insufficiency, Surgery in past 60 days, cancer, symptomatic initial PE
Type: Permanent vena Caval filter 4 types: Vena Tech LGM, titanium Greenfield, Cardial and Bird’s nest

Timing: Inserted through femoral or jugular vein immediately after randomisation

Additional non- comparative prophylaxis: All patients received OAC from 4th day and for at least 3 months. Patients randomised to receive either UFH or LMWH for 8–12 days
No filter

Additional non- comparative prophylaxis: All patients received OAC from 4th day and for at least 3 months. Patients randomised to receive either UFH or LMWH for 8–12 days
Both groups: visits at 4 months and 1 year. Telephone follow up at 2 yrs

Additional follow-up at 8 years
Symptomatic & asymptomatic PE on 8–12th dayInt: 2/200
Control: 9/200
p value: 0.05
Comments: 2x2 factorial design. Patients also randomised to receive either UFH or LMWH. Denominators used for analysis of primary outcomes unclear. Thrombosis at filter site was found in 16 patients.

At 2 years there were no significant differences between groups in all principal end- points - symptomatic PE, recurrent DVT, major bleeding, death.

* Major bleeding described as Overt haemorrhage that was fatal or required transfusion of at least 2 units of red cells, surgical intervention, or cessation of treatment

Not reported: QoL, PTS, funding
Symptomatic PE at 2 yrs Confirmed by: V/Q scanInt: 6/200
Control: 12/200
p value: 0.16
Fatal PE Based on clinical diagnosisInt: 1/200
Control: 5/200
p value: 0.14
Recurrent DVT at 2 years: Clinical suspicion investigated with venographyInt: 37/200
Control: 21/200
p value: 0.03
Major bleeding at 12 days: *Int: 9/200
Control: 6/200
p value: 0.17
Major bleeding at 2 years: *Int: 17/200
Control: 22/200
p value: 0.40
All cause mortality: At 12 daysInt: 5/200
Cont: 5/200
P value 1.00
All cause mortality: At 2 yearsInt: 43/200
Cont: 40/200
P value 0.71
The PREPIC Study Group636

This study is the long term follow up at 8 years of the RCT published by Decousus et al., 1998154
RCT1+Total: 400

Intervention : n = 200

Control: n = 200
Hospitalised patients: with proximal DVT considered to be at high risk for PE

Intervention: Mean age: 73±11 yrs
M/F:92/108

Control: Mean age: 72±11.5
M/F:98/102

Pre-existing risk factors: History of VTE, Chronic cardiac or respiratory insufficiency, Surgery in past 60 days, cancer, symptomatic initial PE
Type: Permanent vena Caval filter 4 types: Vena Tech LGM, titanium Greenfield, Cardial and Bird’s nest

Timing: Inserted through femoral or jugular vein immediately after randomisation

Additional non- comparative prophylaxis: All patients received OAC from 4th day and for at least 3 months. Patients randomised to receive either UFH or LMWH for 8–12 days
No filter

Additional non- comparative prophylaxis: All patients received OAC from 4th day and for at least 3 months. Patients randomised to receive either UFH or LMWH for 8–12 days
8 yearsSymptomatic PE at 8 yrs Confirmed by: V/Q scanInt: 9/200
Control: 24/200
p value: 0.009
* Major bleeding described as Overt haemorrhage that was fatal or required transfusion of at least 2 units of red cells, surgical intervention, or cessation of treatment

Not reported: QoL, funding
Fatal PE at 8 yrs Based on clinical diagnosisInt: 2/200
Control: 5/200
p value: 0.27
Symptomatic venous thromboembolism at 8 yrsInt: 57/200
Control: 41/200
p value: 0.74
Post-thrombotic syndrome at 8 years:Int: 109/200
Control: 107/200
p value: 0.84
Major bleeding at 8 years: *Int: 26/200
Control: 31/200
p value: 0.48
Mortality at 8 yearsInt: 26/200
Cont: 31/200
P value 0.62

From: Appendix D, Evidence tables

Cover of Venous Thromboembolism
Venous Thromboembolism: Reducing the Risk of Venous Thromboembolism (Deep Vein Thrombosis and Pulmonary Embolism) in Patients Admitted to Hospital.
NICE Clinical Guidelines, No. 92.
National Clinical Guideline Centre – Acute and Chronic Conditions (UK).
Copyright © 2010, National Clinical Guideline Centre - Acute and Chronic Conditions.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

The rights of National Clinical Guideline Centre - Acute and Chronic Conditions to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.