Does prevention of venous thromboembolism impact mortality? A meta-analysis of randomized controlled trials.
*Nicholas D Klemen, *Paul L Feingold, *Alexandria Brackett, Kevin Y Pei
Yale University, New Haven, CT
Objective: To test whether prevention of VTE imparts a mortality benefit.
Design: Meta-analysis and pooled random effect analysis of prospective randomized trials that demonstrated prevention of initial or recurrent VTE by pharmacologic means.
Setting: Multi-institutional medical and surgical experience.
Patients: Individuals at risk of VTE due to cancer, surgery, acute illness or prior VTE.
Interventions: Anticoagulant or antiplatelet therapy to prevent VTE.
Main Outcome Measures: Any-cause mortality; incidences of pulmonary embolism (PE), fatal PE and major bleeding.
Results: We studied data from 44,275 patients in 25 prospective randomized trials. Pharmacologic strategies prevented over half of VTE (incidence 2.5% vs 5.5%, OR 2.6, 95%CI 2.14-3.24), which corresponded to a similar reduction in pulmonary emboli (incidence 0.60% vs 1.39%, OR 2.2, 95%CI 1.73-2.88). However, there was not a significant decrease in fatal pulmonary emboli (incidence 0.19% vs 0.26%, OR 1.3, 95%CI 0.83-1.98) and all-cause mortality was not impacted (9.62% in prevention vs 9.60% in control, OR 1.04, 95%CI 0.96-1.11, P=0.3369). Patients in the prevention group experienced a significant increase in major bleeding episodes (0.74% vs 0.49%, OR 0.71, 95%CI 0.55-0.91, P=0.0077).
Conclusions: Pharmacologic strategies can prevent over half of VTE and PE but may not impact mortality. There was a trend towards reduced fatal PE in patients receiving pharmacologic prevention, but this may have been offset by a significant increase in major bleeding episodes. VTE have been described as the most common cause of preventable hospital death, but our results suggest current strategies to prevent VTE do not impact mortality. Future trials investigating therapies for VTE should balance the effect of bleeding complications and focus on patient-centered outcomes such as symptoms, cost or length of stay.
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