Bernadette Satger

EDUC'AVK: Reduction of Oral Anticoagulant-related Adverse Events After Patient Education: A Prospective Multicenter Open Randomized Study.

BackgroundLong-term oral anticoagulation treatment is associated with potential morbidity. Insufficient patient education is linked to poorly controlled anticoagulation. However the impact of a specific educational program on anticoagulation related morbidity remains unknown.ObjectiveTo evaluate the effect of an oral anticoagulation patient education program in reducing both hemorrhagic and recurrent thrombotic complications.Design/ParticipantsWe conducted a prospective, multicenter open randomized study, comparing an interventional group who received a specific oral anticoagulation treatment educational program with a control group. Eligible patients were older than 18 and diagnosed as having deep vein thrombosis or pulmonary embolism requiring therapy with a vitamin K antagonist for 3 months or more. Our primary outcome was the occurrence of hemorrhagic or thromboembolic events.ResultsDuring the 3-month follow-up the main outcome criteria were observed 20 times (6.6% of patients), 5 (3.1%) in the experimental and 15 (10.6%) in the control group. Consequently, in multivariate analysis, the cumulative risk reduction in the experimental group was statistically significant (OR 0.25, 95% CI 0.1 – 0.7, p < 0.01).ConclusionsPatient education using an educational program reduced VKA-related adverse event rates.

Quantitative high D-dimer value is predictive of pulmonary embolism occurrence independently of clinical score in a well-defined low risk factor population

Summary.  We performed a prospective study to assess whether positive quantitative D‐dimer (DD) levels could be integrated for a selected population in a defined strategy to accurately diagnose pulmonary embolism (PE). For this purpose, 1528 in‐ or outpatients with clinically suspected PE were investigated according to our prescription rules. Clinical probability was defined as low, intermediate or high. Patients in whom DD levels were measured met criteria defined by our previously described decision‐making algorithm: in‐ and outpatients, < 80 years, without surgery in the previous 30 days or active cancer. Nine hundred and twenty‐three patients (60.4%) had quantitative DD measurement using automated latex DD assay (STA‐Liatest D‐Di®). According to our decision‐making algorithm, DD measurement was applied to 70.5% of out‐, and 55.7% of inpatients, and PE diagnosis was ruled out in 49.5% of the 923 patients. This allowed us to confirm prospectively that our specific rules greatly improve the DD testing efficiency. PE was diagnosed in 115 (12.5%) patients. For a 0.5 mg L−1 cut‐off, the test sensitivity was 97.4%, but its specificity was only 56.7%. However, PE prevalence increased gradually with DD levels. The true observed PE prevalence, according to the quantitative assessment of DD levels, differed from that predicted with pretest clinical probability only. Moreover, in this well‐defined patient group, a quantitative DD level > 2 mg L−1 was predictive of PE occurrence independently of the clinical score (odds ratio 6.9, 95% confidence interval 3.7, 12.8). As part of a defined strategy, knowledge of positive DD quantitative value, together with the clinical probability score, improves the PE predictive model. A clinical validation of these results in a follow‐up study would now be necessary before considering the implementation of this strategy into clinical practice.

A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency

BACKGROUND Apart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4-C5). METHODS This was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires. RESULTS Four hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa: +9.3%; 95% confidence interval [CI], +5.6 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: -1.2; 95% CI, -1.6 - -0.8; Ctr: -0.6; 95% CI, -1.0 - -0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1 year (Spa: -0.03; 95% CI, -0.57 - +0.51; Ctr: +0.87; 95% CI,+0.46 - +1.26; P = .009). EuroQol 5D improved in the treatment group (Spa: +0.01; 95% CI, -0.02 - +0.04) while it worsened (Ctr: -0.07; 95% CI, -0.10 - -0.04) in the control group (P < .001). A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2 scale (Spa: -2.0; 95% CI, -4.4 - +0.4; Ctr: +2.4; 95% CI, +0.2 - +4.7; P = .008). The control patients showed similar improvements in clinical severity, symptoms, and quality of life after their own spa treatment (day 547). CONCLUSIONS In this study, the incidence of leg ulcers was not reduced after a 3-week spa therapy course. Nevertheless, our study demonstrates that spa therapy provides a significant and substantial improvement in clinical status, symptoms, and quality of life of patients with advanced venous insufficiency for at least 1 year.

Discordant D‐dimer results of two rapid quantitative automated assays are related to age

We read with interest the recently published paper by Carrier et al. [1] on the use of D-dimer (DD) in the elderly. This study demonstrates that the combination of a low Wells pre-test probability with a negative DD value safely excludes deep vein thrombosis (DVT) in elderly patients (aged over 60 years). However, the results of this study, based on pooled results of three technically different DD assays, are not totally in agreement with three other studies [2–4], and the authors suggest that this discrepancy might be explained by differences in the specificity of the DD assays. DD assays have been extensively evaluated, and meta-analyses were recently performed to determine the best tests [5,6]. One limitation of these approaches is that the findings are mainly based on an indirect comparison of the test performance from various studies and hence, mostly from heterogeneous patient populations. In the study, we compared performances in two rapid quantitative automatedDDassays on the same population and demonstrated that age was the main clinical characteristic related to discordant results between the two tests. We previously published a management study of 1134 consecutive non-selected patients clinically suspected of pulmonary embolism (PE) [7]. In this study, DD (cut-off 0.5 mg L, quantitative ELISA test, Vidas D-Dimer; BioMerieux, Lyon, France): (V) was determined straight away for 656 patients who fulfilled the criteria of our decision-making. For 608 of these patients, citrated plasma was immediately stored at )80 C, and a second DD measurement performed retrospectively using a rapid immunoturbidimetric assay (cutoff 0.5 mg L, STA-Liatest D-DI; Stago, Paris, France): (L). Data were complete for 603 patients (five patients were lost at follow-up) who achieved a 3-month follow-up. DDwere found negative (<0.5 mg L) by both methods (L)/V)) in 259 patients (43%; mean age 50.4 years, SD 16.6). The mean DD values for the two tests were not statistically different. False negatives accounted for 1.92% (CI 95% 0.26–3.58%) and this was identical for the two methods. DD were found to be positive (‡0.5 mg L) by both methods (L+/V+) in 277 patients (mean age 64.2 years, SD 14). Results were not concordant for 67 (11%) patients, of these, 63 (94%) patients neither had PE nor develop PE during the 3-month follow-up. Among these 67 discordant results, 54 were L)/V+ and 13 L+/V). Three patients (4.5%, 95% CI 0–9%) had PE in the L)/V+ group, comparable with one (1.5%, 95% CI 0– 4.3%) (P = 0.6) in the L+/V) group. In fact, all these patients were at high clinical probability. Conversely, 51 of the 67 with discordant results (76.1%, 95%CI 65.9–86.3) were L)/ V+ and did not have any thromboembolic events, compared with 12 (17.9%, 95% CI 8–27.1%) in the L+/V) group (P < 0.0001). To explain this discrepancy in the positive rate between the two tests, we analysed the performances in each test related to the patients clinical characteristics. Both gender and ward origin of the 67 patients with discrepant results did not differ significantly from those of the 536 patients with concordant results. Interestingly, when V DD values only were positive, the patients mean age was 64.2 years (SD 14) but significantly lower, 54.3 years (SD 18), when LDD values were only positive (P = 0.03). Therefore, we tested the difference between DD using both methods according to age. For this purpose, DD obtained using the two tests were recorded for each patient, and DDD (i.e. DD Vidas minus DD Liatest) calculated and expressed for the three age groups. This analysis was performed for 420 patients out of 603, as values above 1 mg L (not given quantitatively by the ELISA method at the time of the study) were excluded. As shown in Fig. 1, there was a significant increase in the difference between the Vidas Correspondence: Gilles Pernod, Vascular Medicine Unit, PPM, CHU Grenoble, BP 217X, 38043 Grenoble cedex 09, France. Tel.: 33 476765717; fax: 33 476765524. E-mail: GPernod@chu-grenoble.fr