Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial.
Patrick Mismetti,Silvy Laporte,Olivier Pellerin,Pierre-Vladimir Ennezat,Francis Couturaud,Antoine Elias,Nicolas Falvo,Nicolas Meneveau,Isabelle Quéré,Pierre-Marie Roy,Olivier Sanchez,Jeannot Schmidt,Christophe Seinturier,Marie-Antoinette Sevestre,Jean-Paul Beregi,Bernard Tardy,Philippe Lacroix,Emilie Presles,Alain Leizorovicz,Hervé Decousus,Fabrice-Guy Barral,Guy Meyer +21 more
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TLDR
Among hospitalized patients with severe acute pulmonary embolism, the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticogulation alone did not reduce the risk of symptomatic recurrent pulmonary emblism at 3 months, and these findings do not support theUse of this type of filter in patients who can be treated with antICOagulation.Abstract:
Importance Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism, their benefit-risk ratio is unclear. Objective To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence. Design, Setting, and Participants Randomized, open-label, blinded end point trial (PREPIC2) with 6-month follow-up conducted from August 2006 to January 2013. Hospitalized patients with acute, symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least 1 criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation (filter group; n = 200) or anticoagulation alone with no filter implantation (control group; n = 199). Initial hospitalization with ambulatory follow-up occurred in 17 French centers. Interventions Full-dose anticoagulation for at least 6 months in all patients. Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group. Filter retrieval was planned at 3 months from placement. Main Outcomes and Measures Primary efficacy outcome was symptomatic recurrent pulmonary embolism at 3 months. Secondary outcomes were recurrent pulmonary embolism at 6 months, symptomatic deep vein thrombosis, major bleeding, death at 3 and 6 months, and filter complications. Results In the filter group, the filter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted. By 3 months, recurrent pulmonary embolism had occurred in 6 patients (3.0%; all fatal) in the filter group and in 3 patients (1.5%; 2 fatal) in the control group (relative risk with filter, 2.00 [95% CI, 0.51-7.89]; P = .50). Results were similar at 6 months. No difference was observed between the 2 groups regarding the other outcomes. Filter thrombosis occurred in 3 patients. Conclusions and Relevance Among hospitalized patients with severe acute pulmonary embolism, the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months. These findings do not support the use of this type of filter in patients who can be treated with anticoagulation. Trial Registration clinicaltrials.gov Identifier:NCT00457158read more
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TL;DR: New ESCardio Guidelines for the Diagnosis and Management of Acute PulmonaryEmbolism developed in collaboration with EuroRespSoc are available.
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Thomas L. Ortel,Ignacio Neumann,Walter Ageno,Rebecca J. Beyth,Rebecca J. Beyth,Nathan P. Clark,Adam Cuker,Barbara A. Hutten,Michael R. Jaff,Veena Manja,Veena Manja,Sam Schulman,Sam Schulman,Caitlin Thurston,Suresh Vedantham,Peter Verhamme,Daniel M. Witt,Ivan D. Florez,Ivan D. Florez,Ariel Izcovich,Robby Nieuwlaat,Stephanie Ross,Holger J. Schünemann,Wojtek Wiercioch,Yuan Zhang,Yuqing Zhang +25 more
TL;DR: Recommendations include the use of thrombolytic therapy for patients with PE and hemodynamic compromise, use of an international normalized ratio (INR) range, and a preference for direct oral anticoagulants over VKA for primary treatment of VTE.
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Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism
Barry F. Jacobson,Erich Minar,Jaromir Chlumsky,Peter Verhamme,Phil Wells,Giancarlo Agnelli,Alexander T. Cohen,Scott D. Berkowitz,Bruce L. Davidson,Frank Misselwitz,Gary E. Raskob,Annelise Segers +11 more
TL;DR: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile.