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




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Trials

, 15:423

First Online: 30 October 2014Received: 04 February 2014Accepted: 16 October 2014DOI: 10.1186-1745-6215-15-423

Cite this article as: Gouëffic, Y., Kaladji, A., Guyomarch, B. et al. Trials 2014 15: 423. doi:10.1186-1745-6215-15-423

Abstract

BackgroundCurrently, 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-DesignA 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.

DiscussionThis 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 registrationClinicaltrials.gov identifier: NCT02004951. 3 December 2013.

KeywordsSuperficial femoral artery Bare metal stent Drug eluting stent Paclitaxel AbbreviationsABIankle brachial index

CRAclinical research assistant

CTcomputed tomography

DESdrug eluting stents

eCRFelectronic case report form

EQEuroQol

MACEmajor adverse clinical event

MRAmagnetic resonance angiogram

PSVpeak systolic velocity

PSVRpeak systolic velocity ratio

PVRpeak velocity ratio

RVDreference vessel diameter

RXrapid-exchange

SFAsuperficial femoral artery

TASCTrans-Atlantic Inter-society Consensus Document on Management of Peripheral Arterial Disease

TERtarget extremity revascularization

TLRtarget lesion revascularization.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-423 contains supplementary material, which is available to authorized users.

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Autor: Yann Gouëffic - Adrien Kaladji - Béatrice Guyomarch - Carine Montagne - Damien Fairier - Simon Gestin - Valéry-Pierre Ri

Fuente: https://link.springer.com/







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