Primary studies included in this systematic review

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Primary study

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Journal European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
Year 2010
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OBJECTIF: Cette étude vise à évaluer la valeur prédictive de l'obstruction veineuse résiduelle (RVO) pour récurrente thrombo-embolie veineuse (TEV) dans une étude utilisant des D-dimères pour prédire les résultats. CONCEPTION: C'est une étude en ouvert multicentrique randomisé. Méthodes: Les patients avec un premier épisode de MTEV idiopathique étaient inscrits le jour de l'anticoagulation arrêt quand RVO a été déterminée par échographie de compression dans ceux avec proximale thrombose veineuse profonde (TVP) des membres inférieurs. D-dimères a été mesurée après 1 mois. Les patients avec D-dimères normale n'ont pas repris l'anticoagulation alors que les patients avec D-dimères anormal ont été randomisés pour reprendre l'anticoagulation ou non. Le critère de jugement principal était la récidive de MTEV plus de 18 mois de suivi. RÉSULTATS: Un total de 490 patients atteints de TVP ont été analysés (après exclusion pour des raisons différentes 19 et 118 pour l'embolie pulmonaire isolé (PE)). TVP récurrente s'est produite dans 19% (19/99) des patients avec D-dimères anormal qui n'a pas repris l'anticoagulation et 10% (31/310) chez les sujets ayant des D-dimères normal (hazard ratio ajusté: 2,1, p = 0,02). Les récidives étaient similaires chez les sujets soit avec (11%, 17/151) ou sans RVO (13%, 32/246). Taux de TVP récurrentes étaient également similaires pour D-dimères normal, avec ou sans RVO, et D-dimères anormal, avec ou sans RVO. CONCLUSIONS: Élevé D-dimère à 1 mois après l'arrêt du traitement anticoagulant est un facteur de risque de récidive, tandis que RVO au moment du retrait de l'anticoagulation n'est pas.

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Primary study

Unclassified

Auteurs Siragusa, S
Conférence 14th Congress of the European Hematology Association
Year 2009
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BACKGROUND: Type and duration of anticoagulation is still matter of debate in cancer patients with acute Deep Vein Thrombosis (DVT) of the lower limbs. Residual Vein Thrombosis (RVT) has been proven to be effective for assessing the optimal duration of oral anticoagulants in non cancer patients (Siragusa S et al. Blood 2008:112:511-5). In the present study we evaluate the role of a RVT-based management of anticoagulation with Low-Molecular Weight Heparin in cancer patients with acute DVT. MATERIALS AND METHODS: Cancer patients with a first episode of DVT Were treated with LMWH at therapeutic dosage for 1 month followed By dose reduction of 25% in the next 5 months. At this time, they were managed according to RVT findings: those with RVT were randomized to continue anticoagulants for 6 additional months (Group A1) or to stop (Group A2), while patients without RVT stopped LMWH (Group B). Outcomes were recurrent venous thromboembolism and/or major bleeding. RESULTS: Over a period of 18 months, 134 patients were evaluated across 12 centers in Italy; total duration of follow-up was 30.5 years and median duration of follow-up was 1.2 + 0.2 years. RVT was detected in 92 (68.6%) patients; recurrent events occurred in 23.4% of those who discontinued and 15.5% of those who continued LMWH (Figure 1). The adjusted Hazard Ratio (HR) for age and sex (Group A2 vs A1) was 1.58 (95% confidence interval [CI], 0.85-2.93; p=0.145). Of the 42 (31.3%) patients without RVT , one had a recurrence (2.3%) (Figure 1). The adjusted HR (B vs A1) was 4.54 (CI 2.3-6.66; p=0.028). One major bleeding event occurred in each group of patients who stopped (Group A2 and B) and 2 in those who continued anticoagulation. Overall, 31 (23.1%) patients died due to cancer progression after a median followup of 13.2 months after randomization. CONCLUSIONS: The Cancer DACUS is the first study evaluating an individual marker for assessing duration Of anticoagulation in active cancer population. This interim analysis Shows that absence of RVT identifies a group of patients at low risk for recurrent thrombosis who can safely stop LMWH after 6 months.

Primary study

Unclassified

Journal Journal of thrombosis and haemostasis : JTH
Year 2008
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DACUS (Duration of Anticoagulation based on Compression UltraSonography)

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Primary study

Unclassified

Auteurs Siragusa, S.
Journal 13th Congress of the European Hematology Association
Year 2008
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BACKGROUND: The optimal duration of Oral Anticoagulant Therapy (OAT) for Deep Vein Thrombosis (DVT) can be tailored by Residual Vein Thrombosis (RVT) (Siragusa S et al. Blood 2003;102(11):OC183), a marker able to assess the individual risk for recurrent thrombosis. However, in patients with idiopathic DVT the safety of early interruption of OAT, because of absence of RVT, is still debated. Objective of the study. In the present study, we evaluated the safety of withholding OAT, in patients with idiopathic DVT and without RVT, three months after the index thrombotic episode. STUDY DESIGN: Prospective controlled study with two groups: patients without RVT stopped OAT after 3 months while those with RVT continued for additional 3 months. MATERIAL AND METHODS: Consecutive patients with a first episode of idiopathic DVT of the lower limbs. Patients with cancer or known thrombophilia were excluded. At the third months of OAT, RVT was assessed as previously described; briefly, RVT was considered absent when a clot occupying less than 40% of the vein lumen was detected by compression ultrasonography. Events, classified as recurrent DVT and/or Pulmonary Embolism and/or major and minor bleeding were evaluated; all patients were followed-up for at least 12 months after OAT discontinuation. RESULTS: During the period 1999-2006, 518 patients were included in the study. In 206 (39.7%) RVT was considered absent (RVT negative group) and they stopped OAT; the remaining 312 patients continued anticoagulants for additional 3 months (RVT positive group). Total duration of follow-up (FU) was 184.7 years for RVT negative group (with a mean FU of 3.0+0.83 years) and 191.3 years for RVT positive group (with a mean FU of 3.1+0.89 years). The recurrent events [n/100 person-year (%)] between patients with and without RVT were 63/191.3 (32.9%) and 2/184.7 (1.08%), respectively. This difference was statistically significant (p<0.0005). Major bleeding occurred in 3/312 (0.9%) of patients Who continued OAT for 1 year; no events were Recorded in those who stopped anticoagulation after 3 months. In Figure 1 is reported the Kaplan-Mayer curve of recurrent events between RVT positive and negative group. CONCLUSIONS: This investigation shows that in patients without RVT, three months of OAT Are safe even after an episode of idiopathic DVT. This hold for at least 30% of the entire DVT population and has an important clinical impact; in fact, it is possible to select a group of patients with a very low risk for recurrency over a period of 3 years. This approach carries also a negligible risk for bleeding.

Primary study

Unclassified

Journal CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
Year 2008
BACKGROUND: Whether to continue oral anticoagulant therapy beyond 6 months after an "unprovoked" venous thromboembolism is controversial. We sought to determine clinical predictors to identify patients who are at low risk of recurrent venous thromboembolism who could safely discontinue oral anticoagulants. METHODS: In a multicentre prospective cohort study, 646 participants with a first, unprovoked major venous thromboembolism were enrolled over a 4-year period. Of these, 600 participants completed a mean 18-month follow-up in September 2006. We collected data for 69 potential predictors of recurrent venous thromboembolism while patients were taking oral anticoagulation therapy (5-7 months after initiation). During follow-up after discontinuing oral anticoagulation therapy, all episodes of suspected recurrent venous thromboembolism were independently adjudicated. We performed a multivariable analysis of predictor variables (p < 0.10) with high interobserver reliability to derive a clinical decision rule. RESULTS: We identified 91 confirmed episodes of recurrent venous thromboembolism during follow-up after discontinuing oral anticoagulation therapy (annual risk 9.3%, 95% CI 7.7%-11.3%). Men had a 13.7% (95% CI 10.8%-17.0%) annual risk. There was no combination of clinical predictors that satisfied our criteria for identifying a low-risk subgroup of men. Fifty-two percent of women had 0 or 1 of the following characteristics: hyperpigmentation, edema or redness of either leg; D-dimer > or = 250 microg/L while taking warfarin; body mass index > or = 30 kg/m(2); or age > or = 65 years. These women had an annual risk of 1.6% (95% CI 0.3%-4.6%). Women who had 2 or more of these findings had an annual risk of 14.1% (95% CI 10.9%-17.3%). INTERPRETATION: Women with 0 or 1 risk factor may safely discontinue oral anticoagulant therapy after 6 months of therapy following a first unprovoked venous thromboembolism. This criterion does not apply to men.

Primary study

Unclassified

Journal Thrombosis and haemostasis
Year 2005
Nous avons évalué la valeur prédictive des D-dimères en association avec l'obstruction veineuse résiduelle (RVO) de thrombo-embolie veineuse (TEV) récurrente dans une cohorte prospective de patients ambulatoires après un traitement anticoagulant par voie orale (OAT) de suspension pour un premier épisode de profonde proximale idiopathique thrombose veineuse des membres inférieurs au cours d'une 2-ans de suivi. Les patients (N = 400) étaient inscrits le jour de la suspension OAT lorsque RVO a été déterminé par échographie de compression (présent dans 48,6% des patients). D-dimères (valeur seuil: 500 ng / mL) a été mesurée 30 + / -10 jours après (anormale dans 56,4% des patients). Le taux de récidive global était de 16,7% (67/400; 95% des intervalles de confiance - CI -: 13-21%). Le ratio de risque relatif multivarié (HR) pour la récidive était 3,32 (IC 95%: de 1,78 à 6,75, p <0,0001) pour les D-dimères anormal par rapport à la normale des D-dimères et de 1,2 (IC à 95% :0.72-2 0,07, p> 0,05) pour RVO par rapport à l'absence d'OVR. Le taux de récidive était de 5,7% (IC à 95% :2-13%) et 10,4% (IC à 95% :6-18%), respectivement, pour la normale des D-dimères soit avec ou sans RVO, 22,9% (IC 95%: 14-33%) et 25,9% (IC 95%: 18-35%), respectivement, pour les D-dimères anormal, que ce soit avec ou sans RVO. En comparaison avec la normale des D-dimères sans RVO, le RR multivarié de récidive était similaire pour les D-dimères anormaux soit avec RVO (4,76 - 95% CI :1.78-12 0.8) ou sans RVO (4,3 à 95% :1.56-11 .88). Anormale des D-dimères moins un mois après le retrait de l'OAT est un facteur de risque indépendant de récidive de MTEV, tandis que RVO au moment du retrait OAT, soit avec la normale ou anormale des D-dimères après un mois, n'influence pas le risque de récidive.

Primary study

Unclassified

Journal Haematologica
Year 2005
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Nous avons évalué la valeur prédictive des D-dimères (Dd) et l'obstruction résiduelle veineuse (RVO), seul ou en combinaison, pour la thromboembolie veineuse (TEV) récurrente sur un suivi d'une cohorte de 88 patients atteints de cancer de 2 ans après l'anticoagulant oral traitement (OAT) après le retrait d'un premier épisode proximale thrombose veineuse profonde des membres inférieurs. RVO, déterminée par échographie de compression sur la journée de l'OAT suspension (T1), et anormal Dd (valeur de coupure: 500 ng / ml), mesuré à T1 et 30 + / -10 jours après, sont des facteurs de risque indépendants de récidive de MTEV chez les patients cancéreux.

Primary study

Unclassified

Journal Annals of internal medicine
Year 2002
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BACKGROUND: The optimum duration of anticoagulant therapy after an episode of deep venous thrombosis (DVT) is controversial. Contributing to the controversy is uncertainty about whether residual venous thrombosis, as assessed by repeated ultrasonography over time, increases the risk for recurrent thromboembolism. OBJECTIVE: To determine the risk for recurrent thromboembolism in patients who have persistent residual thrombosis compared with patients who have early vein recanalization. DESIGN: Prospective cohort study. SETTING: A university hospital in Padua, Italy. PATIENTS: 313 consecutive symptomatic outpatients with proximal DVT who received conventional short-term anticoagulation. MEASUREMENTS: Ultrasonographic assessment of the common femoral and popliteal veins was performed 3 months after acute DVT in all patients and at 6, 12, 24, and 36 months in patients found to have residual venous thrombosis. Veins were considered recanalized if they were 2.0 mm or less in diameter on a single test or 3.0 mm or less in diameter on two consecutive tests. Recurrent thromboembolism was assessed during a 6-year period. RESULTS: The cumulative incidence of normal results on ultrasonography was 38.8% at 6 months, 58.1% at 12 months, 69.3% at 24 months, and 73.8% at 36 months. Of 58 recurrent episodes, 41 occurred while the patient had residual thrombosis. The hazard ratio for recurrent thromboembolism was 2.4 (95% CI, 1.3 to 4.4; P = 0.004) for patients with persistent residual thrombosis versus those with early vein recanalization. CONCLUSIONS: Residual venous thrombosis is an important risk factor for recurrent thromboembolism. Ultrasonographic assessment of residual venous thrombosis may help clinicians modify the duration of anticoagulation in patients with DVT.