Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial

BACKGROUND: Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles’ heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm). METHODS/DESIGN: A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease. DISCUSSION: This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02004951. 3 December 2013

Sources de données, données utilisées et modalité de recueil

International audienceThe hospital costing process implies access to various sources of data. Whether a micro-costing or a gross-costing approach is used, the choice of the methodology is based on a compromise between the cost of data collection, data accuracy, and data transferability. This work describes the data sources available in France and the access modalities that are used, as well as the main advantages and shortcomings of: (1) the local unit costs, (2) the hospital analytical accounting, (3) the Angers database, (4) the National Health Cost Studies, (5) the INTER CHR/U databases, (6) the Program for Medicalizing Information Systems, and (7) the public health insurance databases.Les méthodes de costing hospitalier nécessitent d’avoir recours à des sources de données diverses, que l’on travaille selon une approche micro-costing ou gross-costing, le choix de la méthodologie reposant sur un compromis entre coût de recueil, précision et transférabilité. Ce travail décrit les sources de données disponibles en France, les modalités d’accès pratiques ainsi que les principaux avantages et inconvénients : (1) des coûts unitaires locaux, (2) de la comptabilité analytique hospitalière, (3) de la base d’Angers, (4) de l’Étude nationale des coûts, (5) des bases de données inter CHR/U, (6) du programme de médicalisation des systèmes d’information, (7) des bases de données de l’Assurance Maladie

Budget Impact Analysis of Heparin-Bonded Polytetrafluoroethylene Grafts (Propaten) against Standard Polytetrafluoroethylene Grafts for below-the-Knee Bypass in Patients with Critical Limb Ischaemia in France

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A Randomized Controlled Trial Comparing Crude Versus Heparin-Bonded PTFE Graft in Below the Knee Bypass Surgery for Critical Limb Ischemia (REPLACE Trial): Design and Protocol

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Towards outpatient management of tubo-ovarian abscesses?

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Management of external cephalic version in France: A national practice survey

International audienceIntroduction: The breech presentation represents 4,7% of deliveries at term. There is a method of external cephalic version (ECV) performed from 36 weeks of gestation. French guidelines for the clinical practice of ECV were published in 2020. Objective: To evaluate the national practices of ECV in French maternity units, especially on the use of tocolysis, 1 year after publication of the French clinical recommendations guidelines by the French national college of obstetricians and gynecologists (CNGOF). Methods: Data self-reported for this national descriptive study were collected from March to May 2021 by an online questionnaire distributed to all French maternities. The 25 items of the questionnaire collected information of maternity units, the general practice of ECV, use or not of tocolysis for ECV attempt and the relevance of a prospective study. Results: Of the 517 French maternity units, 150 (29%) responded to the online survey. 95,3% systematically performed ECV. A Kleihauer test was routinely performed in 71 units (49.7%). A tocolysis was associated with ECV attempt in 52.4% of cases. The drugs used were intravenous atosiban (30,7%), mainly in levels 2b and 3 maternity units, intravenous salbutamol (24%), other mode of administration of salbutamol (14,7%) and oral nifedipine (22,6%) mainly in levels 1 and 2a maternity units. Adverse effects were described in 20%, mainly with the use of salbutamol (73,3%). Conclusions: 52.4% of the French maternity units surveyed used tocolysis for the ECV attempt, although it is systematically recommended. The choice of tocolytic drug differed according to the maternity units

Analysis of cost-effectiveness of chemotherapeutic agents and new therapies for the management of unresectable and metastatic melanoma

International audienceBackground: The advent of targeted therapies and immunotherapies has revolutionized metastatic melanoma (MM) management but their use is associated with high daily costs compared to chemotherapies: €2 for dacarbazine versus €175 for immunotherapies and €413 for targeted therapies. While overall survival (OS) has increased, healthcare expenditures are expected to double by 2030.Objectives: The aim of this study was to estimate the median OS and costs for MM patients in order to evaluate the effectiveness of new biological or targeted therapies (NT) used since 2013 compared to chemotherapies.Materials & methods: This was a retrospective monocentric cost-effectiveness analysis performed in CHU Nantes (Nantes University Hospital). All MM patients treated with conventional chemotherapy as first-line treatment between 2008 and 2012 were included (CHEMO group). The same number of patients treated with NT as first-line between 2013 and 2017 were included (NT group).Results: In total, 161 patients were included in each group. The mean age at diagnosis was 64.7±2.4 years in the CHEMO group and 65.3±2.4 years in the NT group (not significant). The men/women ratio was 1.48 and 1.27, respectively, (not significant). The median OS was 158 days in the CHEMO group and 395 days in the NT group (p<0.001). Treatment cost was €10,280/patient versus €94,676/patient, respectively. The mean incremental cost-effectiveness ratio was €90,184/LY (95% CI: €59,637; €166,395).Conclusion: Our study assessed clinical and economic features associated with MM management before and after the advent of NT. Costs and life expectancy have increased. NT appears to be cost-effective