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Six months versus two years of oral anticoagulation after a first episode of unprovoked deep-vein thrombosis. The PADIS-DVT randomized clinical trial.

Journal Haematologica
Year 2019
Liens Pubmed DOI PubMed Central

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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The optimal duration of anticoagulation after a first episode of unprovoked deep-vein thrombosis is uncertain. We aimed to assess the benefits and risks of an additional 18 months of treatment with warfarin versus placebo, after an initial 6 months of anticoagulation for a first unprovoked proximal deep-vein thrombosis. We conducted a multicenter, randomized, double-blind, controlled trial comparing an additional 18 months of warfarin with placebo in patients with a unprovoked proximal deep-vein thrombosis initially treated for 6 months (treatment period: 18 months; follow up after treatment period: 24 months). The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months. Secondary outcomes were the composite at 42 months, as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. All outcomes were centrally adjudicated. A total of 104 patients, enrolled between July 2007 and October 2013 were analyzed on an intention-to-treat basis; no patient was lost to follow-up. During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; P<0.001). During the entire 42-month study period, the composite outcome occurred in 14 patients (cumulative risk, 36.8%) in the warfarin group and 17 patients (cumulative risk, 31.5%) in the placebo group (hazard ratio, 0.72; 95% confidence interval: 0.35-1.46). In conclusion, after a first unprovoked proximal deep-vein thrombosis initially treated for 6 months, an additional 18 months of warfarin therapy reduced the composite of recurrent venous thrombosis and major bleeding compared to placebo. However, this benefit was not maintained after stopping anticoagulation. Clinical registration: this trial was registered at www.clinicaltrials.gov as #NCT00740493.

Primary study

Unclassified

Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.

Journal The New England journal of medicine
Year 2017
Liens Pubmed DOI

Cet article est inclus dans 5 Systematic reviews Systematic reviews (5 references)

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BACKGROUND: Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin. METHODS: In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. RESULTS: A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. CONCLUSIONS: Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).

Primary study

Unclassified

Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort.

Journal Thrombosis research
Year 2016
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Choosing short-term (3-6 months) or indefinite anticoagulation after a first unprovoked venous thromboembolic event (VTE) is a common and difficult clinical decision. The long-term absolute risk of recurrent VTE after a first unprovoked VTE, in all patients and sub-groups, is not well established, hindering decision making. METHODS: We conducted a multi-center multi-national prospective cohort study in first unprovoked VTE patients to establish the long-term risk of recurrent VTE after short-term anticoagulation in first unprovoked VTE patients (and sub-groups).We followed patients for symptomatic suspected VTE off of OAT. Suspected recurrent VTE was investigated with reference to baseline imaging and then independently and blindly adjudicated. FINDINGS: We recruited 663 participants between October, 2001 and March 2006 with the last follow-up in April 2014. During a mean 5.0 years of follow-up, 165/663 suspected VTE (in 408 patients) were adjudicated as recurrent VTE resulting in an annualized risk of recurrent VTE of 5.0% (95% CI: 4.2-5.8%) with a cumulative risk of 29.6% at 8 years. Men had a 7.6% (95% CI: 6.3-9.2%) annual risk of recurrent VTE. High risk women (2 or more HERDOO2 points; see text) had an annual risk of recurrent VTE of 5.9% (95% CI: 4.2-8.1%). Low risk women (1 or 0 HERDOO2 points) had 1.1% (95% CI: 0.6-2.0%) annual risk of recurrent VTE with a cumulative risk of 8.7% at 8 years. INTERPRETATION: Men and high risk women with unprovoked VTE should be considered for long-term anticoagulant therapy given a high risk of recurrent VTE after long-term follow-up. Women with a low HERDOO2 score may be able to safely discontinue anticoagulants. FUNDING: This study was funded by the Canadian Institutes of Health Research (Grant # MOP 64319) and Heart and Stroke Foundation of Ontario (Grant # NA 6771). Registered at www.clinicaltrials.gov identifier: NCT00261014.

Primary study

Unclassified

The long-term recurrence risk of patients with unprovoked venous thromboembolism: an observational cohort study.

Journal Journal of thrombosis and haemostasis : JTH
Year 2016
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Essentials Long-term recurrence risk of venous thromboembolism (VTE) is uncertain. We performed a prospective cohort study of 839 patients with first unprovoked VTE. VTE recurrence risk is high, particularly in men with proximal thrombosis or pulmonary embolism. Sex and VTE site determine the recurrence risk and should be considered for patient counseling. SUMMARY: Background The long-term recurrence risk (ltRR) of venous thromboembolism (VTE) is uncertain. Objective To assess the ltRR of patients with first unprovoked VTE. Patients/methods Patients were classified into three categories: distal deep vein thrombosis (DVT), proximal DVT or pulmonary embolism (PE), that is, PE associated with DVT or isolated PE. Patients with major thrombophilia or antithrombotic therapy were excluded. The endpoint was recurrent symptomatic VTE. Results A total of 839 patients were followed for a median of 7.7 years. VTE recurred in 263 patients (31%). After 10 and 20 years, the cumulative ltRR was 32% (95% confidence interval [CI], 29-36) and 44% (95% CI, 38-49) with 3.9 (95% CI, 3.3-4.6) and 3.3 (95% CI, 2.7-4.0) events per 100 patient-years, respectively. The adjusted hazard ratio was 2.1 (95% CI, 1.4-3.2) and 2.1 (95% CI, 1.4-3.2) for patients with proximal DVT or PE compared with patients with distal DVT and was 2.1 (95% CI, 1.6-2.9) for men compared with women. At 10 years, 4.7 (95% CI, 3.8-5.8) events per 100 patient-years occurred in men with proximal DVT or PE, 2.4 (95% CI, 1.2-4.4) in men with distal DVT, 1.9 (95% CI, 1.2-2.8) in women with proximal DVT or PE and 0.9 (95% CI, 0.2-1.9) in women with distal DVT. Conclusion The ltRR of patients with first unprovoked VTE is high and dependent upon sex and VTE site.

Primary study

Unclassified

Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial.

Journal JAMA
Year 2015
Liens Pubmed DOI

Cet article est inclus dans 5 Systematic reviews Systematic reviews (5 references) 1 Structured summary of primary studies Structured summaries of primary studies (1 reference)

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IMPORTANCE: The optimal duration of anticoagulation after a first episode of unprovoked pulmonary embolism is uncertain. OBJECTIVES: To determine the benefits and harms of an additional 18-month treatment with warfarin vs placebo, after an initial 6-month nonrandomized treatment period on a vitamin K antagonist. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind trial (treatment period, 18 months; median follow-up, 24 months); 371 adult patients who had experienced a first episode of symptomatic unprovoked pulmonary embolism (ie, with no major risk factor for thrombosis) and had been treated initially for 6 uninterrupted months with a vitamin K antagonist were randomized and followed up between July 2007 and September 2014 in 14 French centers. INTERVENTIONS: Warfarin or placebo for 18 months. MAIN OUTCOMES AND MEASURES: The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months after randomization. Secondary outcomes were the composite at 42 months (treatment period plus 24-month follow-up), as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. RESULTS: After randomization, 4 patients were lost to follow-up, all after month 18, and 1 withdrew due to an adverse event. During the 18-month treatment period, the primary outcome occurred in 6 of 184 patients (3.3%) in the warfarin group and in 25 of 187 (13.5%) in the placebo group (hazard ratio [HR], 0.22; 95% CI, 0.09-0.55; P = .001). Recurrent venous thromboembolism occurred in 3 patients in the warfarin group and 25 patients in the placebo group (HR, 0.15; 95% CI, 0.05-0.43); major bleeding occurred in 4 patients in the warfarin group and in 1 patient in the placebo group (HR, 3.96; 95% CI, 0.44 to 35.89). During the 42-month entire study period (including the study treatment and follow-up periods), the composite outcome occurred in 33 patients (20.8%) in the warfarin group and in 42 (24.0%) in the placebo group (HR, 0.75; 95% CI, 0.47-1.18). Rates of recurrent venous thromboembolism, major bleeding, and unrelated death did not differ between groups. CONCLUSIONS AND RELEVANCE: Among patients with a first episode of unprovoked pulmonary embolism who received 6 months of anticoagulant treatment, an additional 18 months of treatment with warfarin reduced the composite outcome of recurrent venous thrombosis and major bleeding compared with placebo. However, benefit was not maintained after discontinuation of anticoagulation therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00740883.

Primary study

Unclassified

The anticoagulation of calf thrombosis (ACT) project: results from the randomized controlled external pilot trial.

Journal Chest
Year 2014
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: There is currently little evidence defining the clinical importance of detecting and treating isolated distal DVT (IDDVT). International guidelines vary regarding diagnostic and therapeutic advice. The potential benefits of anticoagulation are unquantified. We sought to evaluate the feasibility of a randomized controlled study within a modern framework and provide a primary outcome point estimate. METHODS: In this open-label, external pilot randomized controlled trial, consecutive, symptomatic, ambulatory patients with IDDVT were approached for inclusion. Participants were allocated to receive either therapeutic anticoagulation or conservative management. Patients underwent blinded color-duplex imaging at 7 and 21 days and follow-up at 3 months. Principal feasibility outcomes included recruitment rate and attrition. The principal clinical outcome was a composite including proximal propagation, pulmonary embolism, death attributable to VTE disease, or major bleeding. Analysis was by intention to treat. RESULTS: In total, 93 patients with IDDVT were screened, and 70 of those eligible (88.6%) were recruited. All patients but one were followed-up by direct contact after 90 days. Allocation crossover occurred in 15 patients (21.4%). The principal clinical outcome occurred in four of 35 of those conservatively treated (11.4%) and zero of 35 in the anticoagulated group (absolute risk reduction, 11.4%; 95% CI, -1.5 to 26.7, P = .11, number needed to treat of nine). There were no major bleeding episodes. CONCLUSIONS: We have established the feasibility of definitive study regarding the value of therapeutic anticoagulation in IDDVT and provide an approximate point estimate for serious complications with a contemporary conservative strategy. TRIAL REGISTRY: Current Controlled Trials; No.: ISRCTN75175695; URL: www.controlled-trials.com.

Primary study

Unclassified

Two years outcome of isolated distal deep vein thrombosis.

Journal Thrombosis research
Year 2014
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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BACKGROUND: Isolated distal deep vein thrombosis (IDDVT) is frequently found in symptomatic outpatients, but its long term outcome is still uncertain. AIMS: To assess IDDVT long term outcome and the impact of IDDVT characteristics on outcome. METHODS: In a prospective, single center study we enrolled symptomatic outpatients in whom IDDVT was detected by whole-leg compression ultrasonography. Patients with provoked IDDVT were treated with low molecular weight heparins (LMWH) for 30 days while those with unprovoked IDDVT received with vitamin K antagonists (VKA) for three months. The primary end-point was the rate of the composite of pulmonary embolism (PE), proximal deep vein thrombosis (DVT), and IDDVT recurrence/extension during 24 month follow-up. RESULTS: 90 patients (age 61 ± 18, male 48.9%) were enrolled. Risk factors for thrombosis were reduced mobility (34.4%), obesity (25.3%), surgery (15.6%), and previous DVT (15.6%) and cancer in 8 patients (8.9%). Eighty-eight patients were treated (56 with LMWH and 32 with VKA). During follow-up (median 24 ± 2 months), 17 events were recorded, which included 3 PE (two in cancer patients), 4 proximal DVTs (one in cancer patient) and 10 IDDVT. Male sex (HR 4.73 CI95%: 1.55-14.5; p=0.006) and cancer (HR 5.47 CI95%: 1.76-17.6; p=0.003) were associated with a higher risk of complications, whereas IDDVT anatomical characteristics, anticoagulant therapy type, and provoked IDDVT were not. CONCLUSIONS: The risk of recurrent venous thromboembolism after IDDVT may be relevant in male patients or in patients with active cancer. Larger studies are needed to address this issue.

Primary study

Unclassified

Update on distal deep venous thrombosis. Reports of a multicenter study.

Journal International angiology : a journal of the International Union of Angiology
Year 2014
Liens Pubmed

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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AIM: No study of strong methodology could be found to resolve the controversy of optimal treatment of distal deep venous thrombosis (DDVT). Some inconclusive evidence exists on two approaches to care: anticoagulants and compression therapy or compression therapy and Duplex scanning monitoring. Different studies report propagation to popliteal vein in 8% of patients without anticoagulant treatment, while a complete thrombus resolution within 4 weeks occurred in 20% of patients. We report data of a study conducted in patients affected by DDVT and treated with nadroparin administered once daily in association with compression therapy. METHODS: One hundred and ten patients with DDVT of the gastrocnemius or tibial veins, assessed by Duplex scanning, were enrolled in 8 clinical centres of the Lazio Region. At baseline, patient demographics, medical history (including risk factors for DDVT), circumferences of both calves and ankles, and a VAS-pain scale were recorded. At 7 and 28 days from baseline, patients were re-assessed by Duplex scanning, calves and ankles circumferences and VAS-pain were measured, and the patients were asked about possible side effects. RESULTS: At the end of the study period, no propagation to the popliteal vein was observed, and no side effects were reported. Overall, the calf circumference in the affected leg significantly decreased from baseline (38.1 cm) to week 1 (37.1 cm), and to week 4 (35.7 cm). Also the VAS-pain scores significantly decreased during the study - the observed means were 58.4, 30.7, and 12.7 at the three visits, respectively. The percentage of partial recanalization of tibial DVT at 7 days was lower than gastrocnemius DVT (31.6% vs. 59.8%) whereas the percentage of total recanalization at 28 days was comparable (52.6% vs. 59.8%). Complete recanalization occurred in 56.4% of all patients. CONCLUSION: Our study suggests that anticoagulant treatment, associated with compression therapy, is safe and causes clinical improvement (as assessed by calf measurements) and pain relief. Overall complete resolution (56.4%) is significantly higher than in untreated patients (20%). Such results, together with the already reported higher satisfaction of patients for the once-daily administration regimen, should be considered as a viable option for the treatment of DDVT.

Primary study

Unclassified

L'apixaban pour le traitement prolongé de la thromboembolie veineuse.

automatic
Journal The New England journal of medicine
Year 2013
Liens Pubmed DOI

Cet article est inclus dans 26 Systematic reviews Systematic reviews (26 references) 1 Structured summary of primary studies Structured summaries of primary studies (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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CONTEXTE: L'apixaban, un inhibiteur oral du facteur Xa qui peuvent être administrés selon un schéma simple, à dose fixe, peut être une option pour le traitement prolongé de la thromboembolie veineuse. Méthodes: Dans cette étude randomisée, en double aveugle, nous avons comparé deux doses de apixaban (2,5 mg et 5 mg, deux fois par jour) à un placebo chez des patients présentant la maladie thromboembolique veineuse qui avaient terminé 6 à 12 mois de traitement anticoagulant et pour lesquels il était clinique équilibre quant à la poursuite ou l'arrêt du traitement anticoagulant. Les médicaments de l'étude ont été administrés pendant 12 mois. Résultats: Un total de 2486 patients ont subi la randomisation, dont 2482 ont été inclus dans l'analyse en intention de traiter. Thromboembolie veineuse symptomatique récurrente ou la mort de thromboembolie veineuse ont eu lieu dans 73 des 829 patients (8,8%) qui recevaient un placebo, par rapport à 14 des 840 patients (1,7%) qui recevaient 2,5 mg d'apixaban (une différence de 7,2 pourcentage points, intervalle de confiance à 95% [IC]: 5,0 à 9,3) et 14 des 813 patients (1,7%) qui recevaient 5 mg d'apixaban (une différence de 7,0 points de pourcentage; CI, 04.09 à 09.01 95%) (P < 0,001 pour les deux comparaisons). Les taux de saignements majeurs étaient de 0,5% dans le groupe placebo, 0,2% dans le groupe apixaban 2,5 mg et de 0,1% dans le groupe apixaban 5 mg. Les taux de saignements de nonmajor cliniquement pertinente de 2,3% dans le groupe placebo, 3,0% dans le groupe apixaban 2,5 mg et de 4,2% dans le groupe apixaban 5 mg. Le taux de décès toutes causes confondues était de 1,7% dans le groupe placebo, contre 0,8% dans la 2.5 mg groupe apixaban et de 0,5% dans le groupe apixaban 5 mg. CONCLUSIONS: anticoagulation prolongée avec l'apixaban à une dose de traitement (5 mg) ou une dose thromboprophylactique (2,5 mg) réduit le risque de thromboembolie veineuse récurrente, sans augmenter le taux de saignements majeurs. (Financé par Bristol-Myers Squibb et Pfizer; AMPLIFY-EXT nombre ClinicalTrials.gov, NCT00633893.).

Primary study

Unclassified

Isolated calf muscular vein thrombosis is associated with pulmonary embolism and a high incidence of additional ipsilateral and contralateral deep venous thrombosis.

Journal Journal of vascular surgery. Venous and lymphatic disorders
Year 2013
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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OBJECTIVE: Little is known about the natural history of isolated gastrocnemial and soleal vein thrombosis (IGSVT), and recommendations for treatment and follow-up are therefore anecdotal. This study sought to determine the rates of venous thromboembolism (VTE) progression and resolution and the effect of antithrombotic therapy in patients with IGSVT. METHODS: A vascular laboratory database was queried from January 2002 to December 2006 to identify patients with duplex-diagnosed IGSVT and follow-up duplex scan studies. Duplex scan examinations were reviewed to determine rates of resolution and development of new ipsilateral and contralateral VTE. Records were reviewed for comorbid conditions, VTE risk factors, anticoagulation therapy, the effect of anticoagulation on resolution of IGSVT, and diagnosis of pulmonary embolism (PE) confirmed by computed tomographic angiography. RESULTS: Patients with at least one follow-up duplex scan study were included in our analysis. Sixty-five limbs with isolated IGSVT were identified in 57 patients with follow-up duplex scans (mean, 2.75 studies per patient; mean follow-up, 113 days). Twenty patients (35%) received therapeutic anticoagulation after the IGSVT diagnosis. There were seven PEs, two on the same day as initial IGSVT diagnosis, and two within 1 week of diagnosis. IGSVT resolution rates by Kaplan-Meier analysis at 1 and 3 months were 20% and 41%, respectively. Eleven patients (19%) developed additional ipsilateral deep venous thrombosis (DVT; three axial calf vein thromboses and five proximal DVT) or contralateral DVT (one axial calf vein thrombosis [CVT], one IGSVT, and one proximal DVT) during follow-up. Of the eight patients who developed additional ipsilateral DVT, five also developed concurrent contralateral DVT. Overall, 14% of patients developed contralateral DVT. Median time to development of additional DVT was 10 days. Therapeutic anticoagulation was associated with DVT resolution. However, VTE recurrence was not significantly affected by age, gender, anticoagulation, oral contraceptives, known hypercoagulable states, or comorbidities (smoking, cancer, trauma, postsurgical status, renal failure, hyperlipidemia, diabetes, or cardiopulmonary abnormalities; P > .05). CONCLUSIONS: Isolated calf muscular vein thrombosis is associated with PE and a significant incidence of VTE progression. Therapeutic anticoagulation is associated with DVT resolution, but its effect on VTE recurrence was not demonstrated. Untreated patients with IGSVT should receive follow-up bilateral lower extremity venous duplex scans within 10 days of diagnosis.