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

Registre nantais des endoprothèses aortiques fenêtrées et branchées

But de l'étude : ce travail a pour objectif de rapporter les données de l'expérience nantaise du traitement endovasculaire des anévrysmes de l'aorte abdominale juxta, para-rénale et le anévrysmes thoraco abdominaux de type II, III et IV par endoprothèses fenêtrées et branchées. Méthode : il s'agit d'une étude prospective monocentrique de 23 cas réalisée au CHU de Nantes entre mai 2007 et aout 2012. Le recrutement a été motivé par les études nationales WINDOWS 1 et 2. Nous avons étudié les paramètres suivants: la mortalité précoce et globale, la réduction de volume anévrysmal, le taux d'endofuite, le taux de perméabilité, le taux de reprises et les complications générales à 1, 6 12, 24, 36 mois Résultats : notre durée de suivi moyenne est de 23 mois. La mortalité précoce est de 8,7% et la mortalité globale de 17,4%. Aucun facteur de risque préopératoire n'a été identifié comme ayant un impact sur la mortalité. La réduction du diamètre anévrysmal est apparue après le premier mois. Notre taux d'endofuite est de 30,4%. Notre taux de reprise est de 17,4%. Un cas de paraplégie complète a été constaté. Conclusion : les résultats de cette étude locale semblent correspondre aux données de la littérature internationale et sont donc encourageants à moyen terme, malgré la faible puissance statistique liée à l'effectif réduit de notre registre.NANTES-BU Médecine pharmacie (441092101) / SudocSudocFranceF

Comparison of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease with Flat-Panel Detectors on Mobile C-arm versus Fixed Systems

International audienceBackground: Flat-panel detectors on mobile C-arm (MC-arm) systems are currently challenging fixed C-arm (FC-arm) systems used in hybrid operating rooms. MC-arm systems offer an alternative to FC-arm systems in the endovascular treatment of peripheral arterial disease (PAD) but their efficiency has not been evaluated comparatively. Methods: Two series of patients undergoing arteriography with intention to treat were included. Each series consisted of 2 nonrandomized groups: an MC-arm group and an FC-arm group. Series 1 evaluated exposure to the patient (MC-arm, n = 113; FC-arm, n = 206) while series 2 evaluated exposure to patients and also health care personnel (MC-arm, n = 24; FC-arm, n = 76). The primary end points for evaluating exposure were air kerma (AK, in mGy) for patients and effective dose for health care personnel (in μSv). Results: After adjustment for the effect of body mass index (analysis of covariance test), AK was found to be lower in the MC-arm group than in the FC-arm group (124.1 ± 142 vs. 173.3 ± 248.7, P = 0.025). There was no difference between the groups with regard to effective dose recorded for senior surgeons or for operating room nurses. However, a higher effective dose was recorded by the MC-arm group external dosimeter for the trainee resident and for nurse anesthetists. Conclusions: In endovascular treatment of lower limb PAD, use of an FC-arm system is associated with more radiation exposure to the patient than an MC-arm system. However, this type of imaging system does not appear to affect exposure to health care personnel. © 2017 Elsevier Inc