The da Vinci Trial
Trial question
What is the role of early prophylactic placement of vena cava filter in patients with major trauma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 240
240 patients (56 female, 184 male).
Inclusion criteria: severely injured patients who had a contraindication to anticoagulant agents.
Key exclusion criteria: imminent death, confirmed PE on admission to the trial center, systemic anticoagulant treatment before injury, pregnancy, and unavailability of an interventional radiologist to insert the filter within 72 hours after admission.
Interventions
N=122 vena cava filter (filter placed within the first 72 hours after admission for the injury).
N=118 control (no filter placement).
Primary outcome
Symptomatic pulmonary embolism or death from any cause at 90 days
13.9%
14.4%
14.4 %
10.8 %
7.2 %
3.6 %
0.0 %
Vena cava
filter
Control
No significant
difference ↔
No significant difference in symptomatic PE or death from any cause at 90 days (13.9% vs. 14.4%; HR 0.99, 99% CI 0.51 to 1.94).
Secondary outcomes
Significant decrease in the rate of symptomatic PE between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury (0% vs. 14.7%).
No significant difference in death from any cause at 90 days (13.1% vs. 9.3%; RR 1.41, 95% CI 0.69 to 2.87).
No significant difference in major bleeding at 90 days (70.5% vs. 66.1%; RR 1.07, 95% CI 0.9 to 1.27).
Safety outcomes
No significant difference in incidence of major and nonmajor bleeding and DVT in a leg.
Significant difference in entrapped thrombus within the filter noted at the first attempt to remove the filter (4.9% vs. n/a).
Conclusion
In severely injured patients who had a contraindication to anticoagulant agents, vena cava filter was not superior to control with respect to symptomatic PE or death from any cause at 90 days.
Reference
Kwok M Ho, Sudhakar Rao, Stephen Honeybul et al. A Multicenter Trial of Vena Cava Filters in Severely Injured Patients. N Engl J Med. 2019 Jul 25;381(4):328-337.
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