Author + information
- Received July 8, 2019
- Revision received November 25, 2019
- Accepted December 3, 2019
- Published online February 17, 2020.
- Yann Gouëffic, MD, PhDa,b,∗ (, )
- Antoine Sauguet, MDc,
- Pascal Desgranges, MD, PhDd,
- Patrick Feugier, MD, PhDe,
- Eugenio Rosset, MD, PhDf,
- Eric Ducasse, MD, PhDg,
- Adrien Kaladji, MD, PhDh,
- Lucie Salomon du Mont, MD, PhDi,
- Jean Marc Pernès, MD, PhDj,
- Philippe Commeau, MDk,
- Patrick Lermusiaux, MDl,
- Brice Leclere, MD, PhDm,
- Béatrice Guyomarc’h, MScn,
- Clément T. Hoffmann, MDo and
- Blandine Maurel, MD, PhDb,p
- aHôpital Paris St. Joseph, Department of Vascular and Endovascular Surgery, Paris, France
- bLaboratoire de Physiopathologie de la Résorption Osseuse, Inserm-UN UMR-957, Nantes, France
- cClinique Pasteur, Toulouse, France
- dAP-HP, Hôpital Henri Mondor, Service de Chirurgie Vasculaire, Créteil, France
- eHôpital Edouard Herriot, Service de Chirurgie Vasculaire, Lyon, France
- fCHU Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Chirurgie Vasculaire, Clermont-Ferrand, France
- gCHU Bordeaux, Hôpital Pellegrin, Service de Chirurgie Vasculaire, Bordeaux, France
- hCHU Rennes, Service de Chirurgie Vasculaire, Rennes, France
- iCHU Besançon, Hôpital Jean Minjoz, Service de Chirurgie Vasculaire, Besançon, France
- jHôpital Privé d’Antony, Antony, France
- kPolycliniq ue Les Fleurs, Ollioules, France
- lBourgoin-Jallieu, Bourgoin-Jallieu, France
- mCHU Nantes, Department of Epidemiology, Nantes, France
- nCHU Nantes, Institut du Thorax, INSERM, CNRS, UNIV Nantes, Nantes, France
- oCHU Brest, Service de Médecine Vasculaire, Brest, France
- pCHU de Nantes, Service de Chirurgie Vasculaire, Institut du Thorax, Nantes, France
- ↵∗Address for correspondence:
Dr. Yann Gouëffic, Vascular Center, Groupe Hospitalier Paris Saint Joseph, 185 rue Raymond Loisserand, 75014, Paris, France.
Objectives The primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions.
Background No randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions.
Methods BATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period.
Results Between March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization.
Conclusions In the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.
The BATTLE trial was funded by Terumo Medical Corporation. Dr. Gouëffic has received research funding from Bard, Medtronic, Terumo, and W.L. Gore; and has received personal fees and grants from Abbott, Bard, Biotronik, Boston Scientic, Medtronic, Terumo, Vygon, and W.L. Gore (modest). Dr. Commeau has received personal fees and grants from Boston Scientific, Medtronic, Edwards Lifesciences, Terumo, and Abbott (modest). Dr. Maurel has received personal fees and grants from Cook (modest). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 8, 2019.
- Revision received November 25, 2019.
- Accepted December 3, 2019.
- 2020 American College of Cardiology Foundation
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