A hospital discharge risk score for 1-year all-cause mortality or non-fatal cardiovascular events in patients with lower-extremity peripheral artery disease, with and without revascularisation.

International audienceOBJECTIVES: This study aims to determine a hospital discharge prognostic risk score for patients with lower-extremity peripheral artery disease (PAD) with and without revascularisation. DESIGN, MATERIALS AND METHODS: A prognostic score on mortality or non-fatal cardiovascular events was determined using the database of a multicentre prospective study enrolling consecutive patients hospitalised for PAD (COhorte de Patients ARTeriopathes, COPART). RESULTS: We analysed the data of 640 patients in the derivation cohort and 517 in the validation cohort. The risk score (and corresponding points) included the following factors: age 75-84 years (+2), ≥ 85 years (+3); previous myocardial infarction (+1); creatinine clearance: ≤ 30 ml min(-1) 1.73 m⁻² (+1.5), 0.30-0.59 (+1), ankle-brachial index: 1.3 (+2); C-reactive protein (CRP) ≥ 70 mg l⁻¹ (+2); and association of statins, anti-platelet agents and renin-angiotensin system inhibitors (-1.5). The frequency of the composite outcome increased significantly with the predicted risk: low risk (≤ 0 point), 2%; medium (0.5-2 points), 12.8%; high (2.5-4 points), 23%; very high (≥ 4.5 points): 42.2%. The model had a good performance in terms of discrimination (C-statistic 0.74 and 0.76) and calibration (Hosmer-Lemeshow 0.65). CONCLUSIONS: We propose the validated COPART risk score for hospitalised severe PAD. This prognostic risk score is based on six variables easily identifiable in clinical practice. Our study highlights the favourable prognostic impact of the prescription at discharge of combined drug therapies

Factors influencing quality of life in children with low‐flow vascular malformations: a qualitative study using focus groups

International audienceBackground Very few studies have evaluated the quality of life (QoL) of children suffering from low-flow vascular malformations. This is the first study investigating the influencing factors.Objectives To identify the factors influencing QoL in children with low-flow vascular malformations.Methods We conducted a qualitative study employing focus group interviews (Clinical Trials Number: NCT03440827). The study was a prospective, interventional, non-comparative, multicentre study performed in four expert centres for vascular anomalies. Qualitative data about personal experiences, feelings, difficulties, needs and various factors influencing behaviours were collected. Theme-based content analysis (manual and specialist textural software guided) were used to analyse the verbatim transcripts of all focus group sessions. Manual qualitative discourse analysis was performed to identify the different themes and categories. Informatics' analyses were subsequently performed for each individual category.Results Ten focus groups (26 individuals including 10 children aged 11 to 15 years) were conducted until saturation. Influencing factors were related to 4 categories: medical care, self-image, social impat on daily activities and challenging social relationships. These factors were responsible for intrafamily upheavals and may lead to future identity-building problems.Conclusions This study provides an essential framework from which physicians can develop strategies to improve patient care and quality of life. These data may also be useful to develop specific age-sensitive QoL questionnaires

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.)