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

Temporal Artery Ultrasound to Diagnose Giant Cell Arteritis: A Practical Guide.

International audienceThe diagnostic modalities for giant cell arteritis (GCA) have evolved significantly in recent years. Among the different diagnostic tools developed, Doppler ultrasound of the temporal arteries, with a sensitivity and specificity reaching 69% and 82%, respectively, is now recognized as superior and, therefore, is a first-line diagnostic tool in GCA. Moreover, with the increasing development of new ultrasound technologies, the accuracy of Doppler ultrasound in GCA seems to be constantly improving. In this article, we describe in detail the scanning technique to perform while realizing Doppler ultrasound of temporal arteries to assess GCA, as well as the diagnostic performance of this tool according to current literature

[Ankle brachial pressure index (ABPI): color-Doppler versus ultrasound Doppler correlation study in 98 patients after analysis of interobserver reproducibility].

International audienceOBJECTIVE: Ankle Brachial Pressure Index (ABPI) by Doppler ultrasound is the gold standard non invasive method for screening of peripheral arterial disease (PAD). This reference method is little used in routine practice, particularly by vascular disease specialists since the most recent ultrasound devices no longer have continuous wave probes. The purpose of our survey was to assess interobserver reproducibility of color-Doppler measurements made in a first population, then second, to assess the correlation between ABPI measurements made with color-Doppler and with ultrasound Doppler in a second population. METHODS: One hundred twenty patients meeting screening criteria for AOMI defined by the French Health Authorities (HAS, 2006) participated in the study between October 2010 and April 2011 in the Echo Doppler and Vascular Medicine unit of the Brest University teaching hospital: 22 patients for interobserver reproducibility and 98 for color-Doppler - continuous Doppler correlation study. Two independent operators measured the ABPI index in each of the 98 patients using color-Doppler and continuous Doppler in random order, producing 353 measurements. Reliability and reproducibility were assessed using the intraclass correlation coefficient of correlation (ICC) determined with Spearman and the Bland-Altman methods. RESULTS: The ABPI was less than 0.90 in 62% of patients. The color-Doppler reproducibility study showed a mean difference of 0.02 [95% CI: -0.02 to 0.17] using the Bland Altman method with ICC equal to 0.89 (P<0.001). For the intermethod correlation study, the mean difference was 0.03 [95% CI: -0.17 to 0.23], with ICC equal to 0.84 (P<0.001). CONCLUSION: Color-Doppler could be an alternative to Doppler ultrasound for PAD screening or follow-up, depending on the results of further evaluations in larger populations

Normal sonoanatomy of the paediatric entheses including echostructure and vascularisation changes during growth

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Can ARFI elastometry of the salivary glands contribute to the diagnosis of Sjögren's syndrome?

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L’élastométrie par mode ARFI des glandes salivaires peut-elle être une aide au diagnostic du syndrome de Sjögren ?

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Endovenous Celon radiofrequency-induced thermal therapy of great saphenous vein: A retrospective study with a 3-year follow-up

Objective: Our main objective was to evaluate the short- and long-term efficacy of Celon radiofrequency-induced thermal therapy for endovenous treatment of incompetent great saphenous vein. The secondary objectives were to report on possible short-term side effects and complications. Methods: This was a retrospective study of 112 consecutive patients included between 2013 and June 2015. These patients were treated (146 great saphenous vein, C2–C6) either at the hemodynamic room using local anesthesia or at the operating theater under general anesthesia with or without phlebectomy. All patients received radiofrequency-induced thermal therapy at 18 W power, 1 s/cm pullback rate and 5–7 pullbacks per segment of 10 cm (i.e. maximum 10 pullbacks). A clinical follow-up via ultrasound monitoring was done at 1 week, 1 month, 6 months, 1 year, 2 years and 3 years. Results: The 3-year survival occlusion rate was 96.71% and 98% for overall and radiofrequency-induced thermal therapy patients, respectively. No major side effects were observed. A case of endovenous heat-induced thrombosis was reported. Slight neurological disorders were reported (0.88%). Conclusion: Our unit’s endovenous Celon radiofrequency-induced thermal therapy of incompetent great saphenous vein was efficient, well tolerated, without major side effects. Moreover, in order to reduce possible neurological disorders, we advise multiple pullbacks at 1 s/cm and using tumescence anesthesia

Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial

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