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Clinical question: Does a retrievable inferior vena cava (IVC) filter in addition to anticoagulation in patients with an acute pulmonary embolism (PE) decrease the risk of recurrent PE?
Background: Inferior vena cava placement has increased dramatically over the last three decades. Although IVC filter placement benefits patients with a contraindication to anticoagulation, the benefit of a temporary IVC filter in addition to anticoagulation to prevent PE in patients at high risk of recurrence is unknown.
Study design: Randomized, open-label.
Setting: Seventeen French hospitals.
Synopsis: Nearly 400 patients with an acute PE associated with lower extremity thrombosis and at least one additional risk factor for severity were randomized to anticoagulation in combination with a retrievable IVC filter versus anticoagulation alone. Risk factors included age, active cancer, chronic cardiac or respiratory disease, recent ischemic stroke with leg paralysis, bilateral deep vein thrombosis, or right ventricular failure or myocardial injury. Both groups received anticoagulation for six months.
Overall, there was no difference in fatal or symptomatic nonfatal PE in each group at three and six months.
The open-label design is subject to interpretative bias. A blinded outcome assessment committee and a central randomization process were implemented in order to minimize bias. In addition, the study could have been underpowered given the limited number of patients and low PE recurrence rate.
Bottom line: In patients with an acute PE at high risk of recurrent PE, retrievable IVC filter in addition to standard anticoagulation therapy does not decrease the risk of recurrence.
Citation: Mismetti, P, Laporte, S, Pellerin O, et al. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism. JAMA. 2015;313(16):1627-1635.
Clinical question: Does a retrievable inferior vena cava (IVC) filter in addition to anticoagulation in patients with an acute pulmonary embolism (PE) decrease the risk of recurrent PE?
Background: Inferior vena cava placement has increased dramatically over the last three decades. Although IVC filter placement benefits patients with a contraindication to anticoagulation, the benefit of a temporary IVC filter in addition to anticoagulation to prevent PE in patients at high risk of recurrence is unknown.
Study design: Randomized, open-label.
Setting: Seventeen French hospitals.
Synopsis: Nearly 400 patients with an acute PE associated with lower extremity thrombosis and at least one additional risk factor for severity were randomized to anticoagulation in combination with a retrievable IVC filter versus anticoagulation alone. Risk factors included age, active cancer, chronic cardiac or respiratory disease, recent ischemic stroke with leg paralysis, bilateral deep vein thrombosis, or right ventricular failure or myocardial injury. Both groups received anticoagulation for six months.
Overall, there was no difference in fatal or symptomatic nonfatal PE in each group at three and six months.
The open-label design is subject to interpretative bias. A blinded outcome assessment committee and a central randomization process were implemented in order to minimize bias. In addition, the study could have been underpowered given the limited number of patients and low PE recurrence rate.
Bottom line: In patients with an acute PE at high risk of recurrent PE, retrievable IVC filter in addition to standard anticoagulation therapy does not decrease the risk of recurrence.
Citation: Mismetti, P, Laporte, S, Pellerin O, et al. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism. JAMA. 2015;313(16):1627-1635.
Clinical question: Does a retrievable inferior vena cava (IVC) filter in addition to anticoagulation in patients with an acute pulmonary embolism (PE) decrease the risk of recurrent PE?
Background: Inferior vena cava placement has increased dramatically over the last three decades. Although IVC filter placement benefits patients with a contraindication to anticoagulation, the benefit of a temporary IVC filter in addition to anticoagulation to prevent PE in patients at high risk of recurrence is unknown.
Study design: Randomized, open-label.
Setting: Seventeen French hospitals.
Synopsis: Nearly 400 patients with an acute PE associated with lower extremity thrombosis and at least one additional risk factor for severity were randomized to anticoagulation in combination with a retrievable IVC filter versus anticoagulation alone. Risk factors included age, active cancer, chronic cardiac or respiratory disease, recent ischemic stroke with leg paralysis, bilateral deep vein thrombosis, or right ventricular failure or myocardial injury. Both groups received anticoagulation for six months.
Overall, there was no difference in fatal or symptomatic nonfatal PE in each group at three and six months.
The open-label design is subject to interpretative bias. A blinded outcome assessment committee and a central randomization process were implemented in order to minimize bias. In addition, the study could have been underpowered given the limited number of patients and low PE recurrence rate.
Bottom line: In patients with an acute PE at high risk of recurrent PE, retrievable IVC filter in addition to standard anticoagulation therapy does not decrease the risk of recurrence.
Citation: Mismetti, P, Laporte, S, Pellerin O, et al. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism. JAMA. 2015;313(16):1627-1635.