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: NCT00457158.
OBJECTIVES: The purpose of this study was to evaluate the necessity of and recommend indications for inferior vena cava (IVC) filter implantation during percutaneous endovenous intervention (PEVI) for deep venous thrombosis (DVT).
BACKGROUND: PEVI has emerged as a powerful tool in the management of acute proximal DVT. Instrumentation of extensive fresh thrombus is potentially associated with iatrogenic pulmonary embolism (PE). The true frequency of this complication has not been studied in a randomized fashion. We evaluated IVC filter implantation during PEVI for DVT.
METHODS: A total of 141 patients with symptomatic proximal DVT undergoing PEVI for symptomatic DVT were randomized to receive an IVC filter (70 patients) or no filter (71 patients; control group). The anticoagulation and PEVI regimen were similar between the two groups. Patients with development of symptoms suggestive of PE underwent objective testing for PE.
RESULTS: PE developed in 1 of the 14 symptomatic patients in the filter group and 8 of the 22 patients in the control group (P = 0.048). There was no mortality in any group. Three patients (4.2%) in the control group had transient hemodynamic instability necessitating resuscitory efforts. Predictors of iatrogenic PE were found to be PE at admission; involvement of two or more adjacent venous segments with acute thrombus; inflammatory form of DVT (severe erythema, edema, pain, and induration); and vein diameter of ≥7 mm with preserved architecture.
CONCLUSIONS: IVC filter implantation during PEVI reduces the risk of iatrogenic PE by eightfold without a mortality benefit. A selective approach may be exercised in filter implantation during PEVI.
<b>BACKGROUND: </b>The benefit of adding a vena cava filter to anticoagulation in treating cancer patients with venous thromboembolism remains controversial. We initiated this study as the first prospectively randomized trial to evaluate the addition of a vena cava filter placement to anticoagulation with the factor Xa inhibitor fondaparinux sodium in patients with cancer.<b>METHODS: </b>Sixty-four patients with deep vein thrombosis (86 %) and/or pulmonary embolism (55 %) were randomly assigned to receive anticoagulation with fondaparinux sodium with or without a vena cava filter. Endpoints included rates of complications by treatment arm, recurrent thromboembolism, complete resolution of thromboembolism, and survival rates.<b>RESULTS: </b>No patient had a recurrent deep vein thrombosis; two (3 %) patients had new pulmonary emboli, one in each randomized cohort. Major bleeding occurred in three patients (5 %). Two patients on the vena cava filter arm (7 %) had complications from the filter. Median survivals were 493 days in the anticoagulation only arm and 266 days for anticoagulation + vena cava filter (p < 0.57). Complete resolution of venous thromboembolism occurred in 51 % of patients within 8 weeks of initiating anticoagulation.<b>CONCLUSIONS: </b>No advantage was found for placement of a vena cava filter in addition to anticoagulation with fondaparinux sodium in terms of safety, recurrent thrombosis, recurrent pulmonary embolism, or survival in this prospective randomized trial evaluating anticoagulation plus a vena cava filter in cancer patients. Favorable complete resolution rates of thrombosis were observed on both study arms.
INTRODUCTION: Trials comparing the use of full dose unfractionated heparin (UFH) or low molecular weight heparins (LMWHs) in very elderly patients with impaired renal function are lacking. IRIS aimed to assess whether LMWH is at least as safe as UFH in this population.
MATERIALS AND METHODS: The study included renally impaired patients ≥70 years with acute symptomatic lower limb deep vein thrombosis (DVT). Patients were randomized to initial treatment with either tinzaparin 175 IU/kg once daily (n=269) or activated partial thromboplastin time-adjusted UFH twice daily (n=270). After acute management both groups received vitamin K antagonist to day 90.
RESULTS: The trial was stopped prematurely due to a difference in mortality favoring the UFH group (11.5 vs. 6.3%; p=0.035). Rates of clinically relevant bleedings by day 90 were similar in the tinzaparin (11.9%) and UFH (11.9%) groups, as were rates of confirmed recurrent venous thromboembolism (VTE) (2.6 vs. 1.1%; p=0.34). As the mortality difference could not be explained by bleedings or recurrent VTE, a post-hoc analysis was performed. This identified six baseline characteristics significantly correlated with mortality, of which five were over-represented in the tinzaparin group.
CONCLUSION: The IRIS study was a challenging study involving patients (mean age 83 years) usually excluded from clinical studies, but its early termination has left questions unanswered. The mortality difference observed with tinzaparin vs. UFH in elderly, renally-impaired patients with DVT cannot be explained on the basis of bleedings or recurrent VTE, and may reflect an imbalance of mortality risk factors at baseline.
BACKGROUND: : Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. METHODS: : This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. RESULTS: : Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. CONCLUSION: : Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.
CONTEXTE: Cette étude visait à comparer l'efficacité de l'héparine de bas poids moléculaire, l'héparine non fractionnée parnaparine et chez les patients présentant indiens avec l'angine de poitrine instable.
MÉTHODES ET RÉSULTATS: Dans cet essai randomisé, prospectif et multicentrique 897 patients adultes des deux sexes souffrant d'un angor instable ont été inclus. Tous les patients ont également reçu de l'aspirine par voie orale et un traitement anti-angineux adéquate selon leurs besoins individuels. Les patients du groupe héparine non fractionnée ont reçu l'héparine non fractionnée en bolus intraveineux de 5000 UI suivi d'une perfusion intraveineuse de 800 à 1000 UI / heure pendant 48 heures, suivie de 5000 UI par voie sous cutanée toutes les 6 heures pendant 5 jours. Les patients de l'autre groupe ont été traités avec du sodium parnaparine 6400 UI sous-cutanée une fois par jour pendant 7 jours. Dans le groupe héparine non fractionnée, il y avait 446 patients (310 hommes, 136 femmes) avec un âge moyen de 55,9 + 12,27 années et dans le groupe parnaparine 451 patients (312 hommes, 139 femmes) avec un âge moyen de 57,6 + / - 11,19 années. Les deux groupes étaient similaires en ce qui concerne l'âge et le sexe (p = 0,89 et 0,068, respectivement). Les facteurs de risque cardiovasculaire associés, tels que diabète, hypertension, dyslipidémie, antécédents d'infarctus du myocarde et précédent pontage aorto-coronarien / angioplastie coronarienne transluminale percutanée étaient similaires dans les deux groupes. A la fin de 7 jours, les points finaux primaires (décès, infarctus du myocarde, ou le besoin de revascularisation myocardique) ont été rapportés chez 33 (7,32%) patients dans le groupe parnaparine et 51 (11,43%) patients du groupe héparine non fractionnée. Cette différence était statistiquement significative. A la fin de 30 jours, les données de 330 patients du groupe parnaparine et 334 patients du groupe héparine non fractionnée était disponible pour analyse. Le taux cumulatif de points finaux primaires à la fin de 30 jours a été rapportée chez 40 (12,12%) patients dans le groupe parnaparine et 73 (21,86%) patients du groupe héparine non fractionnée. Cette différence était statistiquement significative. Deux épisodes de saignement majeur chacun ont été signalés dans les deux groupes. Le saignement mineur a été signalé par 12 (2,66%) patients dans le groupe parnaparine et par 115 (25,8%) patients du groupe héparine non fractionnée. Cette différence était statistiquement significative.
CONCLUSIONS: Ajout d'parnaparine au traitement standard de l'angor instable réduit significativement l'incidence des points d'extrémité triple combiné de décès, infarctus du myocarde et de revascularisation nécessaire par rapport à l'héparine non fractionnée. Cet avantage a été observée après 7 jours ainsi que dans les 30 jours de suivi. L'incidence des saignements mineurs était significativement plus faible chez les patients traités avec parnaparine. Ainsi, une administration quotidienne de parnaparine 6400 UI en dose fixe est une alternative sûre et efficace à l'héparine non fractionnée dans le traitement de l'angor instable.
The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).
The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.
CONTEXTE: Dans un essai randomisé chez des patients atteints proximale thrombose veineuse profonde, permanents filtres pour veine cave a réduit l'incidence de l'embolie pulmonaire, mais a augmenté celle de la thrombose veineuse profonde à 2 ans. Un 8-années de suivi a été effectuée afin d'évaluer leur très long terme, un effet. MÉTHODES ET RÉSULTATS: Quatre cents patients atteints proximale thrombose veineuse profonde avec ou sans embolie pulmonaire ont été randomisés soit pour recevoir ou non un filtre en plus du traitement anticoagulant de référence pour au moins 3 mois. Les données sur le statut vital, la thromboembolie veineuse, et syndrome post-thrombotique ont été obtenues une fois par an pour un maximum de 8 ans. Tous les événements documentés ont été examinés à l'aveugle par un comité indépendant. Données sur les résultats étaient disponibles dans 396 patients (99%). Embolie pulmonaire symptomatique est survenue chez 9 patients dans le groupe filtre (taux cumulé de 6,2%) et 24 patients (15,1%) dans le groupe sans filtre (P = 0,008). Thrombose veineuse profonde survenue chez 57 patients (35,7%) dans le groupe filtre et 41 (27,5%) dans le groupe sans filtre (P = 0,042). Syndrome post-thrombotique a été observée dans 109 (70,3%) et 107 (69,7%) patients dans les groupes de filtres et de non-filtre, respectivement. À 8 ans, 201 (50,3%) patients étaient décédés (103 et 98 patients dans les groupes de filtres et sans filtre, respectivement). CONCLUSIONS: A 8 ans, filtres pour veine cave réduit le risque d'embolie pulmonaire, mais a augmenté celle de la thrombose veineuse profonde et n'a eu aucun effet sur la survie. Bien que leur utilisation peut être bénéfique chez les patients à haut risque d'embolie pulmonaire, le recours systématique dans la population générale avec une thromboembolie veineuse n'est pas recommandé.
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.
