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Background: To assess bleeding risk of patients treated by oral anticoagulants, several scores have been constructed to assist physicians in the evaluation of the benefit risk. Most of these scores lack a strong enough level of evidence for use in family practice., Objective: To assess the predictive prognostic accuracy of 13 scores designed to assess the risk of major or clinically relevant non-major (CRNM) bleeding events in a French ambulatory cohort receiving Vitamin-K antagonists (VKA) or direct oral anticoagulants (DOACs) in a family practice setting., Methods: CACAO (Comparison of Accidents and their Circumstances with Oral Anticoagulants) was a multicentre prospective cohort of ambulatory patients prescribed oral anticoagulants. We selected patients from the cohort who had received an oral anticoagulant because of non-valvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE) to be followed during one year by their GP. The following scores were calculated: mOBRI, Shireman, Kuijer, HEMORR2HAGES, ATRIA, HAS-BLED, RIETE, VTE-BLEED, ACCP score, Rutherford, ABH-Score, GARFIEL-AF, and Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT). Prognostic accuracy was assessed by using receiver operating characteristic curves and c-statistics., Results: During 1 year, 3,082 patients were followed. All of the scores demonstrated only poor to moderate ability to predict major bleeding or CRNM in NVAF patients on DOACs (c-statistic: 0.41-0.66 and 0.45-0.58), respectively. The results were only slightly better for patients prescribed VKA (0.47-0.66 and 0.5-0.55, respectively) in this indication. The results were also unsatisfactory in patients treated for VTE., Conclusion: None of the scores demonstrated satisfactory discriminatory ability when used in family practice., Clinical Trial Registration: ClinicalTrials.gov NCT02376777., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The OPTIMEV (OPTimisation de l'Interrogatoire dans l'évaluation du risque throMbo-Embolique Veineux) study has provided some important and innovative information for the management of lower extremity isolated distal deep vein thrombosis (distal DVT). Indeed, if distal deep-vein thrombosis (DVT) therapeutic management is nowadays still debated, before the OPTIMEV study, the clinical relevance of these DVT itself was questioned. Via the publication of 6 articles, between 2009 and 2022, assessing risk factors, therapeutic management, and outcomes of 933 patients with distal DVT we were able to demonstrate that: - When distal deep veins are systematically screened for suspicion of DVT, distal DVT are the most frequent clinical presentation of the venous thromboembolic disease (VTE). This is also true in case of combined oral contraceptive related VTE. - Distal DVT share the same risk factors as proximal DVT and constitute two different clinical expressions of the same disease: the VTE disease. However, the weight of these risk factors differs: distal DVT are more often associated with transient risk factors whereas proximal DVT are more associated with permanent risk factors. - Deep calf vein and muscular DVT share the same risk factors, short and long-term prognoses. - In patients without history of cancer, risk of unknown cancer is similar in patients with a first distal or proximal DVT. - After 3years and once anticoagulation has been stopped, distal DVT recur twice less as proximal DVT and mainly as distal DVT; However, in cancer patients, prognosis of distal and proximal DVT appear similar in terms of death and VTE recurrence., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Purpose: Most real-world studies on anticoagulants have been based on health insurance databases or performed in secondary care. The aim of this study was to compare safety and effectiveness between patients treated with vitamin K antagonists (VKAs) and patients treated with direct oral anticoagulants (DOACs) in a general practice setting., Methods: The CACAO study (Comparison of Accidents and their Circumstances with Oral Anticoagulants) is a multicenter prospective cohort study conducted among ambulatory patients taking an oral anticoagulant. Participants were patients from the study's cross-sectional phase receiving oral anticoagulants because of nonvalvular atrial fibrillation, for secondary prevention of venous thromboembolism, or both. They were followed as usual for 1 year by their general practitioners, who collected data on changes in therapy, thromboembolic events, bleeding, and deaths. All events were adjudicated by an independent committee. We used a propensity score and a Cox regression model to derive hazard ratios., Results: Between April and December 2014, a total of 3,082 patients were included. At 1 year, 42 patients (1.7%) had experienced an arterial or venous event; 151 (6.1%) had experienced bleeding, including 47 (1.9%) who experienced major bleeding; and 105 (4.1%) had died. There was no significant difference between the VKA and DOAC groups regarding arterial or venous events, or major bleeding. The VKA group had a lower risk of overall bleeding (hazard ratio = 0.65; 95% CI, 0.43-0.98) but twice the risk of death (hazard ratio = 1.98; 95% CI, 1.15-3.42)., Conclusions: VKAs and DOACs had fairly similar safety and effectiveness in general practice. The substantially higher incidence of deaths with VKAs is consistent with known data from health insurance databases and calls for further research to understand its cause., (© 2020 Annals of Family Medicine, Inc.)

The risk of venous thromboembolism (VTE) is higher in myeloma patients receiving immunomodulatory compounds. A VTE prophylaxis using low-molecular-weight heparin or aspirin is therefore proposed. Apixaban is an oral direct anti-Xa. Several studies have shown the efficacy and safety of apixaban in VTE prophylaxis compared to enoxaparin. The objective of this prospective phase 2 pilot study was to assess the risk of VTE and bleeding in patients with myeloma treated with immunomodulatory compounds lenalidomide (len) or thalidomide (thal), using apixaban in a preventive scheme. Myeloma patients requiring Melphalan-Prednisone-Thalidomide in the first line, or Lenalidomide-Dexamethasone in the relapse setting received apixaban, 2.5 mg x 2/day for 6 months. Venous (pulmonary embolism-PE, or symptomatic proximal or distal deep vein thrombosis-DVT, or all proximal asymptomatic events detected by systematic proximal bilateral compression ultrasound) or arterial thrombotic events, and bleeding events (ISTH 2005) were registered. One hundred and four patients were enrolled (mean age 69.8 ± 7.8 years), 11 in first line and 93 in relapse. Two venous thrombotic events were observed, for example, an asymptomatic proximal DVT and a symptomatic distal DVT, in the context of apixaban stopped 14 days before, due to lenalidomide-induced thrombocytopenia. No PE or arterial cardiovascular events were reported. Only one major and 11 CRNM hemorrhages were reported. These data must now be confirmed on a randomized large study., (© 2019 Wiley Periodicals, Inc.)

Background: Venous thromboembolism (VTE) prophylaxis is not always part of the usual care of ambulatory surgery patients, and few guidelines are available., Objectives: To collect data on the application of VTE prophylaxis in ambulatory patients., Design: The OPERA study is a large national survey performed in 221 healthcare facilities., Patients: Among patients, 2174 who underwent one of ten selected procedures over two pre-defined days of investigation., Main Outcome Measures: Assessment and management of the postoperative VTE risk., Results: The postoperative VTE risk was assessed as nil (4.1% of the physicians), low (74%) or moderate (20%). This risk was assessed as lower (71%) in ambulatory surgery as compared to conventional surgery. In most centres (94%), a personal patient history of VTE was recorded preoperatively, and in 72% a prophylaxis protocol was systematically applied but only 40% of the responding centres had a written protocol for VTE prophylaxis. The postoperative period (discharge at home) was covered by a VTE protocol for 75% of the centres, with VTE prophylaxis starting postoperatively in 21% of the patients. In these patients, different treatments were applied: below-knee compression stockings (25%); thigh-length compression stockings (21%); intermittent pneumatic compression in the recovery room (1.2%); unfractionated heparin (2.0%); low molecular weight heparins (65%); vitamin K antagonists (0.5%); other treatments, including direct oral anticoagulants (0.5%)., Conclusion: These data underline the need for a better assessment of the VTE risk in ambulatory patients and new studies either with conventional or new agents to be able to build guidelines in this new setting., (Copyright © 2018 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.)

Essentials Long-term risk of recurrence of isolated superficial vein thrombosis (SVT) is under-studied. We analyzed data from a cohort of first SVT and proximal deep vein thrombosis (DVT) without cancer. The risk of recurrence as DVT or pulmonary embolism is twice lower in SVT patients. However, overall risk of recurrence is similar between SVT and proximal DVT patients. Click to hear Dr Decousus' perspective on superficial vein thrombosis SUMMARY: Background Isolated superficial vein thrombosis (iSVT) (without concomitant deep vein thrombosis [DVT] or pulmonary embolism [PE]) is a frequent event, but available data on long-term outcomes are scarce and retrospective. Therefore, we aimed to determine prospectively the risk and type of venous thromboembolism (VTE) recurrence after iSVT and compare them with those of proximal DVT. Methods Using data from the prospective, multicenter, observational, OPTIMEV study, we assessed, at 3 years and after anticoagulants were stopped, the incidence and the type of VTE recurrence (iSVT/DVT/PE) of patients with a first objectively confirmed iSVT without cancer (n = 285), and compared these with those of patients with a first proximal DVT without cancer (n = 262). Results As compared with proximal DVT patients, iSVT patients had a similar overall incidence of VTE recurrence (5.4% per patient-year [PY] versus 6.5% per PY, adjusted hazard ratio [aHR] 0.9, 95% confidence interval [CI] 0.5-1.6), but iSVT recurred six times more often as iSVT (2.7% versus 0.6%, aHR 5.9, 95% CI 1.3-27.1) and 2.5 times less often as deep-VTE events (2.5% versus 5.9%, aHR 0.4, 95% CI 0.2-0.9). Varicose vein status did not influence the risk or the type of VTE recurrence. Saphenian junction involvement by iSVT was not associated with a higher risk of recurrence (5.2% per PY versus 5.4% per PY), but was associated with recurrence exclusively as deep-VTE events. Conclusion In patients with a first iSVT without cancer, after stopping anticoagulants, the incidence of deep-VTE recurrence is half that of DVT patients, but the overall risk of recurrence is similar. Ssaphenian junction involvement seems to influence the risk of deep-VTE recurrence, whereas varicose vein status has no impact or a low impact on VTE recurrence., (© 2017 International Society on Thrombosis and Haemostasis.)

Essentials Clinical significance of cancer-related isolated distal deep vein thrombosis (iDDVT) is unknown. We studied patients with iDDVT, with and without cancer, and proximal DVT with cancer. Cancer-related iDDVT patients have a much poorer prognosis than iDDVT patients without cancer. Cancer-related iDDVT patients have a similar prognosis to cancer-related proximal DVT patients., Summary: Background Isolated distal deep vein thrombosis (iDDVT) (infra-popliteal DVT without pulmonary embolism [PE]) is a frequent event and, in the absence of cancer, is usually considered to be a minor form of venous thromboembolism (VTE). However, the clinical significance of cancer-related iDDVT is unknown. Methods Using data from the observational, prospective multicenter OPTIMEV cohort, we compared, at 3 years, the incidences of death, VTE recurrence and major bleeding in patients with cancer-related iDDVT with those in cancer patients with isolated proximal DVT (matched 1:1 on age and sex) and patients with iDDVT without cancer (matched 1:2 on age and sex). Results As compared with patients with cancer-related isolated proximal DVT (n = 92), those with cancer-related iDDVT (n = 92) had a similar risk of death (40.8% per patient-year (PY) vs. 38.3% per PY; aHR = 1.0, 95% CI[0.7-1.4]) and of major bleeding (3.8% per PY vs. 3.6% per PY, aCHR = 0.9 [0.3-3.2]) and a higher risk of VTE recurrence (5.4% per PY vs. 11.5% per PY; aCHR = 1.8 [0.7-4.5]). As compared with patients with iDDVT without cancer (n = 184), those with cancer-related iDDVT had a nine times higher risk of death (3.5% per PY vs. 38.3% per PY; aHR = 9.3 [5.5-15.9]), a higher risk of major bleeding (1.8% per PY vs. 3.6% per PY; aCHR = 2.0 [0.6-6.1]) and a higher risk of VTE recurrence (5.0% per PY vs. 11.5% per PY; aCHR = 2.0 [1.0-3.7]). The results remained similar in the subgroup of patients without history of VTE. Conclusion Patients with cancer-related iDDVT seem to have a prognosis that is similar to that of patients with cancer-related isolated proximal DVT and a dramatically poorer prognosis than patients with iDDVT without cancer. This underlines the high clinical significance of cancer-related iDDVT and the need for additional studies., (© 2017 International Society on Thrombosis and Haemostasis.)

Background: Recent studies have shown lower rates of cancer following venous thromboembolism (VTE) than previously described., Objectives: To reassess the risk of cancer in patients with clinical symptoms of VTE with or without confirmed VTE., Patients: We used data from OPTIMEV, a French prospective multicenter observational study of patients presenting to hospital and community vascular medicine specialists with suspected VTE. Patients with confirmed VTE (1565) and matched controls without VTE (1847) were followed for 3 years (2006-2009). The main outcome was occurrence of cancer at 3 years, and death was a censoring event., Results: A total of 5.0% [4.0-6.3] of patients with VTE and 3.8% [3.0-4.9] without VTE developed cancer during follow-up. The adjusted hazard ratio (HR) was 1.2 [0.9-1.8] for patients with confirmed VTE (P=0.22). The overall standardized incidence ratio (SIR) was 1.4 [1.1-1.6] for our population, VTE+ and VTE-, compared with the general population, statistically significant (P<0.05)., Conclusions: We found a lower occurrence of cancer after VTE than previously described, with no significant difference between patients whether VTE was confirmed or not. Our results (low incidence and no difference between patients VTE+ or VTE-) provide no argument in favor of an extensive screening for cancer in case of VTE., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Venous thromboembolic disease often arises as a complication of another pathological condition and/or triggering event. Infectious diseases result from both the direct action of the pathogens themselves and their effect on the immune system. The resulting inflammatory process and the coagulation and fibrinolysis processes share common pathways, explaining why infection is associated with thrombosis. In this brief overview, besides certain chronic infectious diseases, we also consider some acute infections, as the mechanisms are likely to be similar, particularly in the initial infective stage or the more acute episodes of a chronic infection. The infectious agent can be viral, bacterial, fungal, or parasitic. However, the literature on the link between infections and venous thromboembolism (VTE) is uneven, favoring infections that are found in more developed countries where physicians have access to VTE diagnostic tools. Thus, large epidemiological studies in this field are restricted to a limited number of the common chronic infectious diseases such as tuberculosis, while for other infections, particularly parasitic and fungal infections, the link with VTE is only evoked in a few scattered case reports., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

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.

Unlabelled: Cancer is associated with venous thromboembolism in 20% of patients. In such patients, thrombosis is difficult to treat, associated with bleeding, recurrence, and death. Specific treatments for venous thromboembolism in cancer are recommended. Guidelines have been implemented in many countries and international guidelines have been recently developed. We evaluated the adhesion to national French guidelines via a survey of cancer patients treated for venous thromboembolism., Methods: A national cross-sectional observational study evaluated the adhesion to guidelines in hospitalized patients. Good clinical practice was defined as initial 10-day treatment with injectable molecules followed by long-term treatment with low molecular weight heparin for at least 3 months. Demographic data, cancer type, stage, treatment, risk factors and type of thrombosis, were recorded., Results: Five patients were included in 47 centers. Overall adhesion to guidelines was present in 59% (55-63%) of patients (295/500). During initial treatment, adhesion was high (487/496; 98%) but dropped (296/486; 62%) during the long-term maintenance. In patients with renal insufficiency, only a fourth of them received the adequate treatment. A majority of patients had metastatic disease (64%). Cancer sites were gastro-intestinal (25%), gynecologic (23%), pulmonary (21%), hematological (14%), urologic (10%), or other (8%). Lung and hematological malignancies were significantly associated with the highest and lowest rates of adhesion., Conclusion: Adhesion to national guidelines for treatment of venous thromboembolism in cancer is not optimal. Good compliance is observed during initial treatment, but drops after 10 days, underlying the need for further education to achieve a better implementation on a national level., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Background: Isolated distal deep vein thrombosis (iDDVT) (i.e. without proximal DVT or pulmonary embolism) represents half of all cases of lower limb DVT. Its clinical significance and management are controversial. Data on long-term follow-up are scarce, especially concerning risk and predictors of venous thromboembolism (VTE) recurrence., Methods: Using data from the OPTIMEV (OPTimisation de l'Interrogatoire dans l'évaluation du risque throMbo-Embolique Veineux) study, a prospective, observational, multicenter study, we compared, 3 years after an index VTE event and after discontinuation of anticoagulants, (i) the incidence and type of recurrence in patients without cancer with a first iDDVT vs. a first isolated proximal DVT (iPDVT) and (ii) predictors of recurrence after iDDVT., Results: Compared with patients with iPDVT (n = 259), patients with an iDDVT (n = 490) had a lower annualized incidence of overall VTE recurrence (5.2% [95% confidence interval 3.6-7.6] vs. 2.7% [1.9-3.8], respectively; P = 0.02) but a similar incidence of pulmonary embolism recurrence (1.0% [0.5-2.3] vs. 0.9% [0.5-1.6], respectively; P = 0.83). An age of > 50 years, unprovoked character of index iDDVT, and involvement of more than one vein in one or both legs each independently tripled the risk of recurrence, with the latter then being ≥ 3% per patient-year. Neither muscular vein nor deep-calf vein location of iDDVT nor clot diameter with compression influenced the risk of recurrence., Conclusions: After stopping anticoagulants, patients with iDDVT have a significantly lower risk of overall VTE recurrence than did patients with iPDVT but a similar risk of serious recurrent VTE. Age > 50 years, unprovoked iDDVT, and number of thrombosed veins (more than one) influenced the risk of recurrence and may help to define patients at significant risk of recurrence., (© 2014 International Society on Thrombosis and Haemostasis.)

Background: Infections are risk factors for venous thromboembolism (VTE), especially if severe and acute. The role of chronic infections such as active tuberculosis is ill defined, although several case reports and small series have suggested an association between tuberculosis and VTE., Methods: Using data from the Premier Perspective database (27 659 947 admissions), we performed a multivariate analysis to assess the specific VTE risk associated with tuberculosis. The analysis was adjusted on classic risk factors for VTE., Results: The prevalence of VTE among patients with active tuberculosis was 2.07% (95% confidence interval [CI], 1.62%-2.59%). In a multivariate analysis model, adults with active tuberculosis had a greater risk of VTE than those without (odds ratio, 1.55 [95% CI, 1.23-1.97], P < .001), close to the previously reported risk associated with neoplasia. No particular link was found between pulmonary tuberculosis and pulmonary embolism, or between extrapulmonary tuberculosis and deep vein thrombosis. This may suggest the preponderant role of a systemic hypercoagulable state over an intrathoracic venous compression mechanism. In-hospital mortality of patients with both active tuberculosis and VTE (11/72 [15%]) was higher than mortality of patients with only active tuberculosis (92/3413 [2.7%]) or only VTE (5062/199 480 [2.5%]) (P < .001). Pulmonary embolism was more frequent in black patients, suggesting that this population, which is also more likely to suffer from tuberculosis, should be followed carefully., Conclusions: Tuberculosis must be considered as a pertinent risk factor for VTE and should be included in thromboembolism risk evaluation similar to any acute and severe infection.

Objective: Assessment of cancer screening in the context of venous thromboembolic disease (VTE) remains controversial. We tried to characterize a population at high risk of developing cancer among patients suffering from VTE., Method: We conducted a retrospective ancillary case-control study among patients with VTE who later had a positive diagnosis of cancer. We assessed the association of cancer with characteristic features of VTE and with the results for four biological markers., Results: Our population included 142 patients (53% men, median age 71 years). Two years after VTE, 24 patients (17%) had cancer. Median values for D-dimers, fibrin monomers and SP-selectin were significantly higher among patients who developed cancer. Logistic regression enabled us to identify two parameters targeting patients with a high risk of cancer: bilateral venous thrombosis (OR: 4.41, 95%CI: 1.41-13.78, P=0.01) and D-dimers superior to 3.8 μg/mL (OR: 3.68, 95%CI: 1.36-9.94, P=0.01). The information provided by these two characteristics was additive; 58% of patients in our population who had both factors developed cancer., Conclusion: Bilateral venous thrombosis and D-dimers superior to 3.8 μg/mL are highly associated with carcinoma. This result requires a prospective validation. It could be useful in limiting the screening process to the population most at risk., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Background: The management strategies for symptomatic isolated superficial vein thrombosis (SVT) (without concomitant deep vein thrombosis [DVT] or pulmonary embolism [PE]) have yet to achieve widespread consensus. Concerns have been raised regarding the usefulness of prescribing anticoagulant treatments to all patients with isolated SVT. Determining the isolated SVT subgroups who have the highest risks of venous thromboembolism (VTE) recurrence (composite of DVT, PE, and new SVT) may facilitate the identification of patients who are likely to benefit from anticoagulant treatment., Design and Methods: We performed a pooled analysis on individual data from two observational, multicenter, prospective studies, to determine predictors for VTE recurrence and their impact in an unselected population of symptomatic isolated SVT patients., Results: One thousand and seventy-four cases of symptomatic isolated SVT were followed up at 3 months. VTE recurrence was observed in 3.9% of the patients; 16.2% of the patients did not receive anticoagulants, and 0.6% experienced a VTE recurrence. Cancer, personal history of VTE and saphenofemoral/popliteal involvement significantly increased the risk of subsequent VTE or DVT/PE in univariate analyses. Only male sex significantly increased the risk of VTE or DVT/PE recurrence in multivariate analyses. Twelve percent of the patients had cancer or saphenofemoral junction involvement, and were at higher risk of DVT/PE recurrence than patients without those characteristics (4.7% vs. 1.9%, P= 0.06)., Conclusions: In patients with symptomatic SVT, only male sex significantly and independently increased the risk of VTE recurrence. Cancer or saphenofemoral junction involvement defined a population at high risk for deep VTE recurrence. Some SVTs might be safely managed without anticoagulants., (© 2012 International Society on Thrombosis and Haemostasis.)

Superficial venous thrombosis (SVT) prognosis is debated and its management is highly variable. It was the objective of this study to assess predictive risk factors for concurrent deep-vein thrombosis (DVT) at presentation and for three-month adverse outcome. Using data from the prospective multicentre OPTIMEV study, we analysed SVT predictive factors associated with concurrent DVT and three-month adverse outcome. Out of 788 SVT included, 227 (28.8%) exhibited a concurrent DVT at presentation. Age >75years (odds ratio [OR]=2.9 [1.5-5.9]), active cancer (OR=2.6 [1.3-5.2]), inpatient status (OR=2.3 [1.2-4.4]) and SVT on non-varicose veins (OR=1.8 [1.1-2.7]) were significantly and independently associated with an increased risk of concurrent DVT. 39.4% of SVT on non-varicose veins presented a concurrent DVT. However, varicose vein status did not influence the three-month prognosis as rates of death, symptomatic venous thromboembolic (VTE) recurrence and major bleeding were equivalent in both non-varicose and varicose SVTs (1.4% vs. 1.1%; 3.4% vs. 2.8%; 0.7% vs. 0.3%). Only male gender (OR=3.5 [1.1-11.3]) and inpatient status (OR=4.5 [1.3-15.3]) were independent predictive factors for symptomatic VTE recurrence but the number of events was low (n=15, 3.0%). Three-month numbers of deaths (n=6, 1.2%) and of major bleedings (n=2, 0.4%) were even lower, precluding any relevant interpretation. In conclusion, SVT on non-varicose veins and some classical risk factors for DVT were predictive factors for concurrent DVT at presentation. As SVT remains mostly a clinical diagnosis, these data may help selecting patients deserving an ultrasound examination or needing anticoagulation while waiting for diagnostic tests. Larger studies are needed to evaluate predictive factors for adverse outcome.

Introduction: Venous thromboembolism is highly prevalent in the elderly population. However, this age group often receives inadequate thromboprophylaxis because of concerns about bleeding risk, denying patients the benefit of proven antithrombotic regimens. Besides, there is a lack of data in non-surgical patients in postacute care facilities., Methods: A multifaceted intervention program addressing venous thromboembolism prophylaxis has been conducted and evaluated in 50 postacute care facilities. Data were collected in two cross-sectional, epidemiologic studies of 1664 patients aged 65 years or older, including a systematic venous complete compression ultrasound., Results: Despite the fact that 56% of patients received pharmacologic prophylaxis, the prevalence of asymptomatic deep venous thromboses (DVT) was 15%. Specific risk factors in this population have been identified: dependence in basic activities of daily living (ADLs), a higher timed Up and Go test score and the presence of pressure ulcers. Implantation of a multifaceted program was followed by a reduction in DVT prevalence (OR=0.58, CI95%, 0.40-0.83). Implication of nurses and physical therapists was associated with an increase in patient's mobilization (62% versus 37%, p<0.01). Nevertheless, we were unable to find any efficacy of medical compression in venous thomboembolism prevention for medical patients., Conclusion: This project shows the high prevalence of venous thromboembolism in postacute care facilities and enhances the need for a multidisciplinary approach to this disease.

Mild or moderate hyperhomocysteinemia as a risk factor for venous thrombosis is still a matter of debate. The strength of this study is to bring a body of elements to evaluate whether hyperhomocysteinemia should be used as a biomarker for venous thromboembolism (VTE). These elements consist of a biological evaluation of several hematological risk factors, and an original control group made of patients with a negative Doppler ultrasonography. A total of 151 cases and 155 controls were included. Total plasma homocysteine level, MTHFR C677T polymorphism, inherited abnormalities of the natural anticoagulant system as well as plasma folate and cobalamin levels were determined. A total of 41 (27.2 %) of cases and only 9 (5.8%) of controls had at least one of the coagulation defects studied. No significant difference was observed for total homocysteine levels between the 2 groups: median (interquartile range) = 8.3 (7.2-10.8) micromol/L for cases and 8.4 (7-10.9) micromol/L for controls. We found significantly more plasma folates and/or cobalamin deficiencies in controls (18.3%) than in cases (8.6%). After adjustment for several variables significantly related to risk factors of VTE, hyperhomocysteinemia (>13.2 micromol/L) was not found statistically associated with VTE: odds ratio 1.36 (95% confidence interval, 0.52-3.54). The prevalence of the homozygous 677TT polymorphism in the MTHFR gene was not increased in cases compared with controls. Mild or moderate hyperhomocysteinemia does not seem to be a strong determinant in VTE not only when the control group does not exclusively include healthy persons but also in investigated disease-free (thromboembolic disease) controls.

Background: After stopping a 3 to 6 months course of oral anticoagulation for a first episode of idiopathic venous thromboembolism (VTE), the risk of recurrent VTE is high (10% per year). In this setting, international guidelines recommend at least 6 months treatment. However, this recommendation is not satisfactory for the following reasons: (1) no randomized trial has compared 6 months to extended duration (2 years) anticoagulation; and (2), even though the frequency of recurrent VTE is similar after pulmonary embolism (PE) and deep vein thrombosis (DVT), the fatality rate of recurrent VTE after PE is higher than that after DVT., Methods: A French multicentre double blind randomized trial. The main objective is to demonstrate, after a first episode of symptomatic idiopathic PE treated for 6 months using a vitamin K antagonist, that extended anticoagulation for 18 months (INR between 2 and 3) is associated with an increased benefit / risk ratio (recurrent VTE and severe anticoagulant-related bleeding) compared to placebo. The double blind evaluation is ensured using by active warfarin and placebo, and blinded INR. The protocol was approved by the ethics board of the Brest Hospital on the 7th of March 2006. For an alpha risk of 5% and a beta risk of 20%, the estimated sample size is 374 patients., Expected Results: This study has the potential to: (1) demonstrate that the benefit / risk ratio of extended anticoagulation for 18 months is higher than that observed with placebo in patients with a first episode of idiopathic PE initially treated for 6 months, during and after the treatment period; and (2) to validate or invalidate the contribution of isotope lung scans, lower limb Doppler ultrasound and D-Dimer at 6 months of treatment as predictors of recurrent VTE (medico-economic analysis included).

Introduction: In observational studies, a significant difference in the outcomes between treated and untreated patients may be observed in absence of treatment effect and caused by differences in baseline characteristics., Exegesis: Propensity score analysis is a post hoc adjustment method which consists in deriving the conditional probability of receiving the treatment for a patient given his measured baseline characteristics (i.e., the propensity score). Matching each treated patient to an untreated one who has the nearest propensity score tends to balance baseline characteristics between the two groups and reduce the risk for overt bias. Then, the outcomes can be compared between matched treated and untreated patients., Conclusion: Propensity score analysis is relevant for clinical conditions and treatments for which randomized controlled trials are unlikely to be conducted. However, propensity analysis cannot adjust for unmeasured characteristics and sensitivity analysis should be performed to assess how sensitive the conclusions are to potential confounding factors.

Purpose: It is unknown whether data from observational studies can assist guideline developers in areas where scientific evidence is lacking. The purpose of this study is to develop a local clinical guideline for prophylaxis against venous thromboembolism based on observational study results., Design/methodology/approach: The authors performed a classification tree analysis on original data from a cross-sectional study of risk factors, prophylaxis, and prevalence of deep vein thrombosis in 818 medical in-patients hospitalised in French teaching and community hospitals. The dependent variable was the use of pharmacological prophylaxis. The rate of any deep vein thrombosis detected by routine compression ultrasonography was used as an illustrative variable. Using group consensus of expert panelists, a practice guideline was developed based on the results of this study and a systematic review of the literature., Findings: The resulting classification tree involved eight terminal subsets. The mean misclassification rate was 31 per cent in tenfold cross-validation and the area under the ROC curve was 0.75. The classification tree was converted into graded recommendations. According to these recommendations, 455 patients (56 per cent) required prophylaxis. The corresponding rate of deep vein thrombosis was 11 per cent (28/245, [CI = 8-16]) in 245 prophylaxis users and 11 per cent (23/210, [7-16]) in 210 prophylaxis non-users. Conversely, 363 patients (44 per cent) did not require prophylaxis: 63 actually received prophylaxis and six had deep vein thrombosis (2 per cent, [0.6-4])., Research Limitations/implications: Further prospective validation of the guideline is important prior to its implementation., Originality/value: Integrating data from observational studies may be an effective way to develop guidelines when robust scientific evidence is lacking.