Results from six-month data of the PES BTK-70 study have shown 86.2% primary patency in the treatment of short focal lesions in below-the-knee arteries with the self-expanding paclitaxel-eluting Stentys stent. Nearly 90% freedom from target lesion revascularisation was achieved and there was over 98% limb salvage rate.
Marc Bosiers, head, Department of Vascular Surgery, St Blasius Hospital, Dendermonde, Belgium, presented results of the PES BTK-70 study at the Leipzig Interventional Course (LINC; Leipzig, Germany, 28–31 January).
PES BTK-70 is a prospective, multicentre, single arm study of the self-expanding paclitaxel-eluting Stentys stent (Stentys) in the treatment of atherosclerotic tibial-peroneal arteries. The purpose of the study was to evaluate the immediate and long-term (12 months) safety and effectiveness of the Stentys stent in critical limb ischaemia patients with below-the-knee lesions not exceeding 50mm. Bosiers noted that this is “one of the first nitinol self-expanding stents for dedicated below-the-knee use.”
Seventy patients (mean age 74.64 years) with Rutherford classification 4 and 5 participated at six centres in Belgium. “The average lesion length was 20mm, which is more or less the same average lesion treated in the DESTINY and ACHILLES trials with balloon expandable drug-eluting stents,” said Bosiers. Sixty per cent of the lesions were calcified.
The primary endpoint of the study, Bosiers told delegates, was primary patency at six months defined by duplex ultrasound measurement of PSV-ratio ≤2.4 at the target lesion with no clinically-driven re-intervention within the treated segment, verified by core lab. The study also evaluates primary patency at 12 months, defined as absence of restenosis or occlusion within the originally treated lesion based on angiography, verified by core lab.
At six months, Bosiers said, primary patency was achieved in 86.2% of the patients, freedom from target lesion revascularisation in 87.6% patients and there was a high limb salvage rate of 98.5%. Only one patient underwent major amputation, Bosiers noted. The six-month survival rate was 94% and there was improvement in Rutherford classification, leaving just 12 patients in Rutherford 5.
“Six-month primary patency results of the self-expanding Stentys stent system are as good as balloon expandable drug-eluting stents for short focal lesion in below-the-knee arteries,” concluded Bosiers. He told Vascular News that “Self-expanding stents are supposed to be more crush-resistant and they allow to cover larger lesions.”
In order to evaluate the specific mode of action of the drug-eluting self-expanding stent in below-the-knee lesions, he said, “We need the 12-month angiographic data,” which are expected in August 2014, he added.