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The optimal strength of compression needed to prevent post-thrombotic syndrome (PTS) after a proximal deep vein thrombosis (DVT) is debated. We aimed to assess whether 25 mm Hg elastic compression stockings (ECS) are non-inferior to 35 mm Hg ECS in preventing PTS after a DVT.In this multicentre, double-blind, non-inferiority, randomised controlled trial, we enrolled adults (≥18 years) with a first ipsilateral proximal DVT attending 46 French vascular medicine hospital departments or private practices. Participants were randomly allocated (1:1, stratified by centre, age, and sex; with varying block sizes of two and four) to wear 25 mm Hg or 35 mm Hg ECS for 2 years. The primary outcome was the cumulative rate of PTS 2 years after inclusion, defined by a Villalta scale (≥5). Efficacy was assessed by intention-to-treat and in eligible participants who had complete primary outcome data. A per-protocol analysis was also conducted among compliant patients as a secondary outcome measure. Safety was assessed in all participants who used ECS at least once, and for which we have at least some tolerance information during follow-up. The margin for non-inferiority was 12·5%. This study is registered with ClinicalTrials.gov, NCT01578122, and has been completed.Between June 28, 2012, and July 21, 2017, we enrolled 341 eligible participants who consented to randomisation. 233 (68%) were men and median age was 59 years (IQR 45-70). Collection of ethnicity and race as a routine research variable is not authorised in France. Median follow-up was 735 days (IQR 721-760). 249 (73%) had complete data at 2 years. For the primary analysis, 40 (31%) of 129 participants with complete data in the 25 mm Hg ECS group and 40 (33%) of 120 in the 35 mm Hg group had PTS (absolute difference -2·3% [90% CI -12·1 to 7·4], pAlthough we did not reach the prespecified sample size, our results suggest that 25 mm Hg ECS are non-inferior to 35 mm Hg ECS in preventing PTS. Larger more powerful studies are needed.Laboratoires Innothera, France.

The International Consortium for Health Outcomes Measurement assembled an international working group of venous thromboembolism experts and patient representatives to develop a standardised minimum set of outcomes and outcome measurements for integration into clinical practice and potentially research to support clinical decision making and benchmarking of quality of care. 15 core outcomes important to patients and health-care professionals were selected and categorised into four domains: patient-reported outcomes, long term consequences of the disease, disease-specific complications, and treatment-related complications. The outcomes and outcome measures were designed to apply to all patients with venous thromboembolism aged 16 years or older. A measurement tool package was selected for inclusion in the core standard set, with a minimum number of items to be measured at predefined timepoints, which capture all core outcomes. Additional measures can be introduced to the user by a cascade opt-in system that allows for further assessment if required. This set of outcomes and measurement tools will facilitate the implementation of the use of patient-centred outcomes in daily practice.

Background International guidelines recommend using the Villalta score (VS) to diagnose the postthrombotic syndrome (PTS). However, a high proportion of PTS detected with VS could just reflect the presence of preexisting primary venous insufficiency (PVI). Furthermore, it is unclear whether the contralateral VS (cl-VS) can be used to assess for preexisting PVI. Objectives To estimate whether cl-VS can be used to assess for preexisting PVI, and to assess the proportion of PTS that could be attributable to preexisting PVI. Methods Subanalysis of the SOX multicenter randomized trial focusing on patients with a first unilateral proximal deep vein thrombosis (DVT) followed for up to 2 years. PVI was defined as a baseline cl-VS > 4, and PTS as VS > 4 in the leg ipsilateral to DVT starting 6 months after DVT. Results Among 680 patients, mean cl-VS remained stable over time: 1.23 (standard deviation [SD] ±2.49) at baseline and 1.17 (±2.20), 1.59 (±2.81), 1.54 (±2.50), 1.65 (±2.82), and 1.55 (±2.63) at the 1-, 6-, 12-, 18-, and 24-month visits, respectively. Baseline cl-VS and ipsilateral VS measured during follow-up were mildly correlated (Pearson correlation = 0.13-0.25). This association disappeared after subtracting the cl-VS measured at the same visit from the ipsilateral VS. Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS > 4. Conclusion In our study of patients with a first unilateral proximal DVT, the proportion of patients with PTS who had a cl-VS > 4 is modest. However, cl-VS appears to be stable over time. Its assessment could constitute a simple way of documenting preexisting PVI and help to classify patients as having PTS.

Postthrombotic syndrome (PTS) is a burdensome and costly complication of deep vein thrombosis (DVT) that develops in 20%‐40% of patients within 2 years after proximal DVT. In the absence of effective curative treatment, management of PTS relies on its prevention after DVT. The effectiveness of elastic compression stockings (ECS) to prevent PTS is uncertain. We present an overview of published studies assessing the efficacy of ECS to prevent PTS and present the protocol for the CELEST clinical trial. While previous open‐label randomized trials have reported a 50% risk reduction in PTS in patients treated with >30 mm Hg ankle pressure ECS, a large double‐blind trial reported no effect of ECS. We discuss the main potential limitations of these trials, including a placebo effect and suboptimal compliance to ECS. We present the protocol of the CELEST double‐blind randomized trial comparing 2 years of high strength (ankle pressure 35 mm Hg) versus lower strength (ankle pressure 25 mm Hg) ECS in the prevention of PTS after a first acute symptomatic, unilateral, proximal DVT. The use of lower‐strength ECS than that used in previous studies should favor compliance. CELEST may provide important evidence about the efficacy of ECS in the prevention of PTS after DVT. The results will be interpreted in the light of results from recent clinical trials assessing ECS for PTS prevention that reported that the duration of ECS use should be tailored to the individual, if ECS are efficacious in the prevention of PTS.

Resume Introduction La maladie veineuse thromboembolique (thrombose veineuse profonde et embolie pulmonaire) est une pathologie frequente, grave mais aussi chronique. Lors de precedentes etudes, la plupart des medecins traitants et des medecins vasculaires declaraient participer a l’education therapeutique de leurs patients. Objectif Evaluer, du point de vue du patient, le role et l’implication des medecins traitants et des medecins vasculaires dans l’information delivree au patient lors de la prise en charge d’une thrombose veineuse profonde. Methode Enquete telephonique realisee aupres des patients francais inclus dans l’essai therapeutique CACTUS sur le traitement des thromboses veineuses profondes distales des membres inferieurs. Resultats Cent trois patients ont ete interroges. Quatre-vingt-douze pour cent (n = 95) se declaraient satisfaits de l’information recue, jugee necessaire dans 96 % (n = 99) des cas et 85 % (n = 88) des patients n’ont pas eprouve le besoin de consulter d’autres sources d’information. Les medecins vasculaires auraient consacre plus de temps a l’information des patients et auraient delivre un message plus exhaustif et plus comprehensible. Plus de 75 % des patients ont declare qu’aucun medecin n’avait aborde les problematiques des precautions a prendre sous anticoagulants, des complications a long terme et de la prevention de la recidive de la maladie veineuse thromboembolique. Conclusion Dans l’etude CACTUS, les medecins vasculaires auraient consacre davantage de temps a l’information medicale qui est jugee satisfaisante d’apres les patients. Des themes importants n’auraient pas ete abordes suggerant la necessite d’une protocolisation de l’information au patient.

Objectifs Le syndrome post-thrombotique (SPT) est une insuffisance veineuse secondaire a une thrombose veineuse profonde (TVP). C’est la complication la plus frequente des TVP et son incidence et sa severite augmentent avec le temps. Cependant, en raison du faible nombre d’etudes avec un suivi a tres long terme (> 10 ans), l’incidence reelle et les facteurs de risque du SPT a tres long terme sont inconnus. L’objectif de l’etude SPOT est d’apporter des elements de reponses a ces questions. Methode L’etude SPOT est le suivi a 12 ans de 1392 patients avec TVP proximale ou distale et/ou EP et 1392 temoins sans maladie veineuse thromboembolique (MTE) inclus dans l’etude Optimev et en vie a 3 ans. Le critere de jugement principal est le score de Villalta en autoquestionnaire suivi d’un entretien avec un attache de recherche clinique. Presentation pour cet abstract des resultats initiaux des 243 premiers dossiers complets recus (presentation des resultats de 600 dossiers complets attendus en seance). Resultats A l’inclusion, la moyenne d’âge etait de 53 ans ± 13 ans et 57 % des patients etaient des femmes. Cent patients etaient des temoins sans MTE a l’inclusion ou lors du suivi, 79 des TVP distales sans EP, 54 des TVP proximales ± EP et 10 des EP sans TVP (exclus de l’analyse). Un score de Villalta ≥ 10 definissant un SPT invalidant etait retrouve chez 22 % des patients (n = 54) dont 21 % (n = 21) des temoins, 16 % (n = 13) des TVP distales sans EP et 33 % (n = 18) des TVP proximales ± EP. La proportion de SPT severe (Villalta ≥ 15) globale, chez les temoins, les TVP distales et proximales etait respectivement de 10 %, 10 %, 7 % et 15 %. Les facteurs de risque associes a un SPT invalidant/insuffisance veineuse etaient l’obesite, une classe CEAP ≥ 1 et la localisation proximale de la TVP a l’inclusion. Conclusion L’incidence a tres long terme des formes invalidantes du SPT est elevee. Les facteurs independants de la TVP comme la CEAP et l’obesite augmentent le risque de SPT/insuffisance veineuse. Les TVP distales ne semblent pas associees a un risque accru de SPT invalidant.

Objectifs Apres une thrombose veineuse profonde (TVP), des bas de compression elastique (CE) sont frequemment prescrits pour prevenir la survenue d’un syndrome post-thrombotique (SPT). Une observance therapeutique defaillante constitue un frein important a l’efficacite de la CE pour prevenir le SPT. L’utilisation d’une CE moins forte que celle utilisee dans les essais cliniques ( Methodologie Essai therapeutique de non-inferiorite randomise en double insu comparant la CE 25 mmHg vs. 35 mmHg pour prevenir le SPT chez les patients presentant un premier episode de TVP aigue proximale des membres inferieurs sans insuffisance veinolymphatique significative preexistante et traites au moins 3 mois par anticoagulant (clinicalTrial.gov : NCT01578122 ). Le critere principal de jugement est l’incidence cumulee de SPT a 2 ans evaluee par le score de Villalta a 1 ou 2 ans. La marge de non-inferiorite pour la difference de taux de SPT entre les groupes a ete fixee a 12,5 %. Une observance optimale etait definie comme un port de la CE 80 % du temps. Cette etude a ete approuvee par les autorites de sante et un comite d’ethique et tous les patients ont signe un formulaire de consentement eclaire (clinicaltrial.gov : NCT01578122 ). Resultats De 2012 a 2017, 350 patients ont ete randomises. L’incidence cumulee de SPT etait de 31 % dans le groupe 25 mmHg et 33,3 % dans le groupe 35 mmHg (difference absolue −2,3 %, (IC 90 % : −12,1 ; 7,4), p = 0,006 pour la non-inferiorite). L’incidence cumulee de SPT moderes a severes etait de 4 % dans le groupe 25 mmHg et de 9,4 % dans le groupe 35 mmHg, p = 0,09. L’observance dans les groupes 25 mmHg et 35 mmHg etait optimale dans 51,4 % et 41,8 % des cas respectivement, p = 0,1. Chez les patients observants optimaux, l’incidence cumulee du SPT dans les groupes 25 mmHg et 35 mmHg etait de 29,4 % et 21,6 % respectivement, p = 0,3. Conclusions La CE 25 mmHg est non-inferieure a la CE 35 mmHg pour prevenir le SPT a 2 ans et l’observance therapeutique est meilleure numeriquement. Il semble exister une relation dose/reponse chez les patients observants optimaux avec une tendance pour une meilleure observance dans le groupe 25 mmHg.

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. SummaryBackground 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.

Contexte Il y a un manque de connaissances en ce qui concerne la presentation, la prise en charge et le devenir des patients presentant une maladie thromboembolique veineuse (MTEV). De nombreux sous-groupes cliniquement pertinents (comme les personnes âgees, les hemorragies recentes et les patientes enceintes) ont ete sous-representes dans les essais cliniques. En outre, le design des essais cliniques est interessant dans certains scenarios, comme par exemple ceux presentant une embolie pulmonaire (EP) hemodynamiquement instable. Objectifs Registro Informatizado Enfermedad TromboEmbolica (RIETE) est un grand registre prospectif et international en cours, concu pour repondre a ces besoins non satisfaits en utilisant des donnees representatives de plusieurs centres. Methodes Cree en Espagne en 2001, RIETE comprend actuellement 206 centres repartis dans 28 pays et a recrute plus de 87 000 patients atteints de MTEV. L’objectif principal est d’ameliorer la prise en charge de la MTEV grâce a une meilleure comprehension de la prevention, ainsi que des donnees demographiques, des comorbidites, des schemas de traitement et du devenir des patients atteints de MTEV. Resultats RIETE a contribue a caracteriser le modele de presentation et de devenir de la MTEV, y compris dans les sous-groupes peu etudies mentionnes precedemment, dans plus de 150 articles de recherche. RIETE a recemment etendu ses activites a la collecte de donnees sur le devenir a long terme et a elargi ses criteres d’inclusion pour inclure d’autres formes de thrombose veineuse (telles que la thrombose veineuse cerebrale et la thrombose veineuse splanchnique). La plateforme RIETE est egalement utilisee pour mener des etudes comparatives pragmatiques d’efficacite, notamment des essais randomises. Les prochaines etapes seraient axees sur la collaboration avec d’autres centres dans le monde et sur les efforts visant a assurer la qualite et l’extension du registre. RIETE devrait continuer a fournir des preuves cliniques pour les sous-groupes de MTEV sous-etudies et jouer un role plus important dans la facilitation d’etudes multicentriques (et internationales) pouvant etre utilisees pour evaluer les variations et les disparites des soins, l’amelioration de la qualite et conduire des etudes comparatives d’efficacite. Conclusions RIETE est un vaste registre, en cours, de patients atteints de MTEV et d’autres affections thrombotiques. Ses resultats pourraient etre utiles pour ameliorer notre comprehension de l’epidemiologie, des tendances en matiere de soins et du devenir des patients atteints de maladie thrombotique.

Background There is a lack of knowledge with regards to contemporary presentation, management, and outcomes of patients with venous thromboembolism (VTE). Many clinically important subgroups (including the elderly, those with recent bleeding, and pregnant patients) have been under-represented in clinical trials. Further, design of clinical trials is challenging in some scenarios, such as in those with hemodynamically-unstable pulmonary embolism (PE). Objectives RIETE (Registro Informatizado Enfermedad TromboEmbolica) is a large prospective multinational ongoing registry, designed to address these unmet needs using representative data from multiple centers. Methods Initiated in Spain in 2001, RIETE currently includes 206 centers in 28 countries and has enrolled over 87,000 patients with VTE. The overarching goal is to improve the management of VTE through better understanding of prevention, as well as demographics, co-morbidities, treatment patterns, and outcomes of patients with VTE. Results RIETE has helped characterize the pattern of presentation and outcomes of VTE, including in the aforementioned understudied subgroups, in over 150 research articles. RIETE has recently expanded to collect long-term outcomes data, and has broadened its inclusion criteria to enroll other forms of venous thrombosis (such as cerebral vein thrombosis and splanchnic vein thrombosis). The RIETE platform is also being used to conduct pragmatic comparative effectiveness studies, including randomized trials. Future steps would focus on collaboration with additional centers across the world, and efforts to ensure the quality and expansion of the registry. It is expected that RIETE will continue to provide clinical evidence for understudied subgroups with VTE, and will have more prominent role for facilitation of multicenter (and multinational studies) that could be used for assessment of variations and disparities in care, quality improvement, and conducting comparative effectiveness research. Conclusions RIETE is a large ongoing registry of patients with VTE and other thrombotic conditions. Its results could be helpful for improving our understanding of the epidemiology, patterns of care and outcomes of patients with thrombotic disease.

Objectif En cas de suspicion de thromboses veineuses profondes (TVP), lorsqu’un echo-Doppler complet des membres inferieurs est realise, plus de la moitie des TVP diagnostiquees sont de TVP distales (TVP infra-poplitee). Cependant, malgre leur frequence, ces TVP n’ont fait l’objet que de peu d’attention car elles sont considerees comme benignes et ne sont pas diagnostiquees dans la plupart des pays actifs dans la recherche en thrombose. L’objectif de cette communication est de presenter l’apport du registre RIETE a la connaissance des TVP distales isolees des membres inferieurs (sans extension au reseau veineux profond proximal et sans embolie pulmonaire associee). Materiel Analyse des patients presentant une TVP distale isolee inclus dans le registre RIETE. Resultats A ce jour, un seul article centre sur les TVP distales a ete publie. Pres de 2000 patients avec TVP distales isolees ont ete analyses et compares a plus de 9000 patients avec TVP proximales ce qui constitue de loin la plus grosse etude publiee a ce jour sur les TVP distales. Il a ete mis en evidence que : –d’un point de vue epidemiologique, les TVP distales sont davantage associees a des facteurs de risque transitoires et moins a des facteurs de risque permanents ; elles presentent un meilleur pronostic en termes de mortalite en raison d’une moindre mortalite par cancer ; –d’un point de vue therapeutique, alors que les recommandations de bonnes pratiques internationales ne recommandent pas de traiter systematiquement avec des anticoagulants les TVP distales, dans RIETE, reflet de la pratique clinique quotidienne dans un grand nombre de pays, la quasi-totalite des TVP distales etaient traitees avec des anticoagulants, la plupart du temps pour une duree de 3 mois. En raison de son caractere observationnel pur et des differences de pratique diagnostiques, le registre RIETE ne permet pas d’apprehender le poids reel des TVP distales au sein des TVP ni de comparer le pronostic des TVP distales et proximales en termes de recidives thromboemboliques et de saignement. Conclusion RIETE a permis de fournir des donnees epidemiologiques solides sur les TVP distales. Comme toute etude observationnelle, il ne permet pas d’apporter des reponses definitives du point de vue de la prise en charge therapeutique. Des analyses sont en cours pour etudier les facteurs de mauvais pronostic et le pronostic a long terme de ces thromboses.

International audience; INTRODUCTION:Distal deep-vein thromboses (iDDVT) are infra-popliteal DVTs. They are as frequent but less serious than proximal DVT. Their management is debated.METHODS:Clinical practice survey among a random selection of 111 general practitioners (GP) and 56 vascular medicine physicians (VMP) working in Languedoc-Roussillon (France) to assess and compare iDDVTs management by GP and VMP.RESULTS:In case of DVT, GP manage their patients alone in 35% of cases. In case of collaborative management, VMP initiate and stop anticoagulants (>74% of cases) whereas GP monitor anticoagulation (>76% of cases). With iDDVT, there was no difference between GP and VMP in terms of use (94% vs. 92%) and intensity of anticoagulation (full dose: 99%vs.100%). Duration of anticoagulation differed: GP modulated less frequently duration of anticoagulation in presence of a transient risk factor (58% vs. 90%, p

Introduction En cas de thrombose veineuse profonde des membres inferieurs (TVP) l’efficacite de la compression elastique (CE) pour prevenir le syndrome post thrombotique est desormais debattue en particulier pour la prevention du syndrome post thrombotique (SPT). En revanche, les recommandations suggerent l’application d’une CE a la phase aigue de la TVP pour soulager le patient des symptomes de la TVP. Nous presentons ici les resultats de l’etude Celest (Promoteur Innothera) sur l’evolution a court terme des symptomes de TVP. Materiel et methode Essai therapeutique multicentrique en double aveugle comparant la CE appliquant 25 mmHg a la cheville vs. CE appliquant 35 mmHg a la cheville en cas de premiere TVP proximale des membres inferieurs. Nous avons compare l’evolution des symptomes (douleur et œdeme evalues par le patient sur une echelle analogique de 1–100) au cours des 3 premiers mois. Resultats Les resultats presentes dans ce resume sont des resultats preliminaires avant gel de base et en l’absence de levee d’aveugle. Trois cent cinquante patients ont ete randomises (75 % a l’hopital et 25 % en liberal). Leur âge moyen etait de 57,5 ans, 68 % (n = 238) etaient des hommes. Cinquante-huit pour cent (n = 202) presentaient une TVP du membre inferieur gauche et 15 % une extension iliaque. L’evolution, significative, de la diminution des symptomes a 1 semaine (s1), 1 mois (m1) et 3 mois (m3) etait comparable entre les 2 groupes (NS) : pour la douleur, la mediane etait de 28 avec un interquartile de [10–62] a s1, 13 [8–33] a m1 et 9,5 [4–17] a m3 dans le groupe A et de 19 [9–56] a s1, 12 [7–28] a m1 et 8,5 [4–13] a m3 dans le groupe B ; pour l’œdeme, la mediane etait de 24 [10–57] a s1, 14 [6–35] a m1 et 9 [4–16] a m3 dans le groupe A et 14 [7–53] a s1, 10 [5–19] a m1 et 8 [4–13] a m3 dans le groupe B. Discussion Nos resultats montrent la rapide amelioration sous traitement anticoagulant et compression elastique des symptomes aigus de TVP meme si environ 25 % des patients gardent des symptomes cliniquement significatifs (EVA ≥ 15/100) a trois mois. On n’observe pas de difference statistique selon le type de compression. Conclusion La CE 25 mmHg et la CE 35 mmHg sont similairement efficaces pour traiter la douleur et faire regresser l’œdeme a la phase aigue en cas de TVP proximale des membres inferieurs. Ces donnees suggerent que, compte tenu de la plus grande facilite d’enfilage de la CE 25 mmHg, la CE 25 mmHg peut etre egalement utilisee dans cette indication.

The Sapporo criteria-related definition commonly used for diagnosis of the antiphospholipid syndrome (APS) associates the occurrence of thrombotic and/or obstetrical events with persistently positive antiphospholipid antibodies (aPL-Ab), including lupus anticoagulant (LAC), anticardiolipin IgG (aCL-G) or IgM, and/or anti-b2-glycoprotein I IgG or IgM antibodies. Criteria used to define the purely obstetrical clinical subtype of the APS syndrome include the aPLs listed above plus a fetal loss later than 10-weeks gestation, 3 or more unexplained consecutive embryonic losses before the 10th week gestation, or eclampsia or features of placental insufficiency requiring the preterm birth before 34 weeks of a morphologically normal child. Some investigators have questioned the serological criteria associated with this form of APS and have suggested that the aCL-G, anticardiolipin IgM, and anti-b2-glycoprotein I IgM measurements should be excluded. To determine the effects of the various aPL-Ab subtypes on pregnancy outcome, the investigators prospectively monitored women who had had an unexplained embryonic loss during their first pregnancy and were undergoing their untreated second pregnancy. They selected women who did not have APS; any hormonal abnormalities; or inflammatory, infectious, or malignant diseases; and who had normal parental karyotypes; the pregnancy outcomes of 142 women who tested positive for at least 1 of the 5 classical aPL-Abs were compared with those of 142 control women who were confirmed to be aPL-Abs negative. Compared with the women without aPL-Abs, the aPL-Ab-positive women experienced more clinical complications during their second pregnancy, including pregnancy loss (of which the majority were embryonic losses), preeclampsia, placental abruption, and intrauterine fetal growth restriction. The presence of LAC alone (type IIa aPL-Ab positivity) was associated with the highest risk of recurrent embryonic loss and intrauterine growth restriction. Positive tests for combinations of aPL-Ab (type I aPL-Ab positivity) were associated with the highest risk of late complications, placental abruption, and preeclampsia. A finding of anti-b2-glycoprotein I IgM positivity had no apparent diagnostic clinical relevance. These findings demonstrate that among women with a first unexplained pregnancy loss before the 10th week of gestation, those who are aPL-Abs positive have a higher risk of complications in their next pregnancy, including embryonic loss, preeclampsia, placental abruption, and intrauterine growth restriction, than women who are aPL-Abs negative. These findings suggest that the aPL-Ab LAC, aCL-G or IgM, and anti-b2-glycoprotein I IgG are helpful in identifying patients at increased risk of an adverse outcome, whereas anti-b2-glycoprotein I IgM has questionable diagnostic value.

Summary. Background: The clinical significance of symptomatic isolated distal deep vein thrombosis (DVT) is uncertain. Consequently, this leads to important disparities in its management. Objective: To examine the clinical history of isolated distal DVT and to compare it with that of proximal DVT. Methods: Using data from the international, prospective, RIETE registry on patients with confirmed symptomatic venous thromboembolism (VTE), we compared the risk factors and 3-month outcome in patients with isolated distal DVT vs. proximal DVT. Results: Eleven thousand and eighty-six patients with symptomatic DVT, but without pulmonary embolism, were included between 2001 and 2008; 1921 (17.3%) exhibited isolated distal DVT. Anticoagulant treatment was received by 89.1% (1680/1885) of isolated distal DVT and 91.8% (7911/8613) of proximal DVT patients for the entire follow-up period. Isolated distal DVTs were more associated with transient risk factors (i.e. recent travel, hospitalization, recent surgery), whereas proximal DVTs were more associated with chronic states (i.e. ≥75 years or with active cancer). At 3 months, major bleeding rate was lower in patients with isolated distal DVT (1.0% vs. 2.2%, P

BackgroundHalf of all lower limb deep vein thromboses (DVT) are distal DVT that are equally distributed between muscular calf vein thromboses (MCVT) and deep calf vein thromboses (DCVT). Despite their high prevalence, MCVT and DCVT have never been compared so far, which prevents possible modulation of distal DVT management according to the kind of distal DVT (MCVT or DCVT).MethodsUsing data from the French, multicenter, prospective observational OPTimisation de l'Interrogatoire dans l'évaluation du risque throMbo-Embolique Veineux (OPTIMEV) study, we compared the clinical presentation and risk factors of 268 symptomatic isolated DCVT and 457 symptomatic isolated MCVT and the 3-month outcomes of the 222 DCVT and 390 MCVT that were followed-up.ResultsDuring the entire follow-up, 86.5% of DCVT patients and 76.7% of MCVT patients were treated with anticoagulant drugs (P = .003). MCVT was significantly more associated with localized pain than DCVT (30.4% vs 22.4%, P = .02) and less associated with swelling (47.9% vs 62.7%, P < .001). MCVT and DCVT patients exhibited the same risk factors profile, except that recent surgery was slightly more associated with DCVT (odds ratio, 1.70%; confidence interval, 1.06-2.75), and had equivalent comorbidities as evaluated by the Charlson index. At 3 months, no statistically significant difference was noted between MCVT and DCVT in death (3.8% vs 4.1%), venous thromboembolism recurrence (1.5% vs 1.4%), and major bleeding (0% vs 0.5%).ConclusionIsolated symptomatic MCVT and DCVT exhibit different clinical symptoms at presentation but affect the same patient population. Under anticoagulant treatment and in the short-term, isolated distal DVT constitutes a homogeneous entity. Therapeutic trials are needed to determine a consensual mode of care of MCVT and DCVT.