The Femoral Artery Stenting Trial (FAST), comparing the Luminexx stent (Bard) with standalone percutaneous transluminal angioplasty (PTA) for the treatment of lesions in the superficial femoral artery (SFA) was designed to address the poor results achieved using PTA and balloon-expandable stents in patients with SFA disease, where 12-month restenosis rates are between 40% and 50%. Current data (eg SIROCCO) suggest that while nitinol stents may improve mid-term restenosis rates, randomised trials assessing PTA vs nitinol stenting in patients with SFA lesions are lacking. Dr Hans Krankenberg, Center for Cardiology and Vascular Intervention, Hamburg, Germany, presented six-month interim analysis of the FAST results so far.
The Luminexx stent system is composed of the nitinol alloy and combines stent fluoroscopic visibility, optimal radial force with a deployment system that provides placement control and accuracy.
Two hundred and forty-four patients with lesions up to 10cm in length were randomised to receive either a stent (n=123) or angioplasty (n=121). During the study, 13 patients required stenting after angioplasty and therefore crossed over to the stent arm. There were three major adverse events in the stent arm: two amputations owing to prior gangrene and one death owing to colon cancer. The technical success rate, defined as residual stenosis less than 30%, was 93% in this arm. There were no events in the angioplasty arm.
At six months, binary restenosis rates (as determined by Doppler ultrasound) were 25.5% in those treated with the Luminexx nitinol stent versus 38.3% in patients who underwent angioplasty. The reduction did not achieve statistical significance in the intent-to-treat analysis, but the results of the per-protocol analysis, which included 13 patients who crossed from one arm to the other because they required both angioplasty and stenting, were significant (p=0.085). Moreover, reintervention rates also favoured stenting, with 12.4% (15/121 patients) of those patients in the PTA group requiring revascularisation, compared to 6.5% (8/123 patients) in the stenting group. Ankle-brachial index improved by 0.12 in the stent group and by 0.18 in the angioplasty group, both statistically significant.
In conclusion, Krankenberg said the use of the Luminexx nitinol stent reduced restenosis, improved target lesion revascularisation and achieved ankle-brachial index comparable to angioplasty for treatment of lesions in the superficial femoral artery. "All of these indicate a trend towards improved outcome with stenting, however we will have to wait until the complete 12-month data and safety analysis available," commented Krankenberg.
The complete 12-month results will be announced at this year's EuroPCR meeting in Paris, France.
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