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

Development and evaluation of a decision aid for women eligible for organized breast cancer screening according to international standards: A multi-method study

Backgroundand purpose:In France, women lack information to make a shared decision to start breast cancer screening. Decision aids are useful to facilitate this discussion, yet few meet international standards. The objective of this project was to build, validate and measure the quality of a decision aid for organized breast screening in France, in line with international standards, intended for both women and healthcare professionals.Materials and methodsThis mixed-methods study was conducted between January 2017 and June 2022. The prototype was developed from a qualitative study, systematic review and targeted literature review and alpha tested during two Delphi rounds. Readability was evaluated with the Flesch score and content with International Patient Decision Aid Standards Instrument (IPSASi).ResultsAn online decision aid, accessible at www.Discutons-mammo.fr, written in French was developed. The content included eligibility, information about breast screening the advantages and disadvantages of screening, patient preferences and a patient-based discussion guide using text, infographics, and videos. The Flesch readability test score was 65.4 and the IPDASi construct quality score was 176 out of 188.ConclusionsThis decision aid complies with IPDASi standards and could help women eligible for breast screening in France make a shared decision with a specialized healthcare professional about whether or not to participate in organized breast screening