The BATTLE trial comparing a drug-eluting stent (Zilver PTX, Cook Medical) vs. a bare metal stent (Misago, Terumo) for the treatment of intermediate femoropopliteal lesions has failed to the show superiority of the paclitaxel-coated stent at one-year follow-up. The trial highlights a need for further direct comparative data between devices and strategies for treatment of femoropopliteal lesions.
The data were presented for the first time by Yann Gouëffic (Nantes, France) at the Charing Cross Symposium (CX; 24-27 April, London, UK). BATTLE is a French multicentre randomised clinical trial that included 181 patients who were randomised 1:1 into the Zilver PTX drug-eluting stent and Misago bare metal stent arms (n=85 vs. n=86, respectively). Included patients were classed as Rutherford 2–5, with de novo atherosclerotic femoropopliteal lesions of 2–14cm and a reference vessel diameter of 4–7mm.
There are currently several different options for treating TASC A and B lesions, Gouëffic said, including bare metal stents, drug-eluting stent, drug-coated balloons and covered stents. However, few head-to-head randomised trials have been completed so far to compare the safety and efficacy of devices for femoropopliteal lesion treatment.
Data from the Zilver PTX randomised controlled trial indicated that the paclitaxel-coated Zilver PTX fared better compared to a bare metal stent. This comparative data from a second arm of randomization of Zilver PTX trial, Gouëffic explained, led to the hypothesis that Zilver PTX would prove superior to the bare metal Misago stent and subsequently the BATTLE trial was designed as a superiority trial, rather than non-inferiority.
The patient population at baseline showed similar mean lesion lengths and reference vessel diameters, with intermittent claudication present in 79% of patients in the Zilver PTX arm and 82% in the Misago arm. Technical success was 100% in both arms.
At 12 months the primary endpoint—freedom from in-stent restenosis—90.3% in the paclitaxel-eluting stent arm and 85.7% in the bare metal stent arm (p=0.36). The primary endpoint was defined as restenosis of >50%, as well as a peak systolic velocity index of >2.4 at the target lesion.
The trial did show a significant benefit for the paclitaxel-eluting stent with regard to secondary endpoints either. Patency rate was 84.2% vs. 81.6% (p=0.41) for Zilver PTX and Misago, respectively; target extremity revascularisation was 4.9% vs. 3.8% (p=0.52) and notably, target-lesion revascularisation was 8.8% vs. 8.9% (p=0.91), respectively, at 12 months. No difference was seen between the treatment arms in Rutherford stage at baseline or at 12 months. Finally, there was an 88.6% clinical improvement in the Zilver PTX arm vs. 85.3% in the bare-metal stent arm (p=0.56).
Due to the design of the study, Gouëffic explains, they were not able to look at non-inferiority of the Misago stent, as opposed to superiority of the Zilver PTX. “This conclusion is not for all drug-eluting stents,” Gouëffic pointed out, as future generation devices may cause the field to change. “Advantages of drug-eluting therapy in comparison to bare metal stents are still required, to define the strategy for the treatment of intermediate length femoropopliteal lesions,” Gouëffic concluded.