| Decousus H, et al, 1998, France | 400 patients with proximal vein thrombosis. 200 randomised to receive an IVCF and 200 to receive no IVCF. Patients also randomised to receive LMWH or unfractionated heparin | PRCT (two by two factorial design)Multicentre (44 sites) | Rate of recurrent VTE at 12 days: filter group/no filter group | 2 (1.1%) had had symptomatic or asymptomatic PE/9(4.8%) had had symptomatic or asymptomatic PE/6 (3.4%) had symptomatic PE/12 (6.3%) had symptomatic PE | Overall 6 patients died of PE, no breakdown in the paper of filter compared with no filter |
| Follow up data recorded day 12 and two years | | Recurrent VTE at two years: filter group/no filter group | 37 (20.8%) at 2y had had recurrent DVT (95% CI, p = 0.03). (16 had thrombosis at the filter site)/21 (11.6%) at 2y had had recurrent DVT | The study was powered for 400 patients per group (800), however a steering committee interrupted the study because of slow recruitment rate |
| | | Death at 12 days: filter group/no filter group | 5 (2.5%), no PE/5 (2.5%), 4 PE | |
| | | Death at two years: filter group/no filter group | 43 (21.6%)/40 (20.1%) | |
| | | Major bleeding: filter group/no filter group/LMWH/UFH | 17 (8.8%)/22 (11.8%)/16 (8.5%)/23 (12%) | |