Stenting improves outcomes in SFA lesions

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Dr Hans Krankenberg, Center for Cardiology and Vascular Intervention, Hamburg, Germany, has presented a six-month interim analysis of the Femoral Artery Stenting Trial (FAST), which is comparing the Luminexx stent (Bard) with stand-alone percutaneous tranluminal angioplasty (PTA) for the treatment of lesions in the superficial femoral artery (SFA). FAST 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%, Krankenberg said. Current data (eg SIROCCO) suggests that that Nitinol stents may improve mid-term restenosis rates, however, randomised trials assessing PTA vs nitinol stenting in patients with SFA lesions are lacking.

The Luminexx stent system in 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 forty-four patients with lesions up to 10cm in length were randomized to either a stent (n=123) or angioplasty (n=121). During the study, 13 patients required stenting after angioplasty alone and crossed over to the stent arm. There were three major events in the stent arm: two amputations due to prior gangrene and one death due to colon cancer. The technical success rate, defined as residual stenosis less than 30%, was 93% in the stent arm. There were no events in the angioplasty arm.

At six months the results demonstrated binary restenosis rates (as determined by Doppler ultrasound) of 25.5% in those treated with the Luminexx nitinol stent vs 38.3% in patients who underwent angioplasty. The 33% 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=.085). Moreover,

re-intervention rates also favoured stenting, with 12.4% (15/121 patients) of those patients in the PTA group undergoing revascularisation, compared to 6.5% (8/123 patients) in the stenting group. Ankle-brachial index improved by 0.12 in the stent group vs. 0.18 in the angioplasty group, a statistically significant difference.

In conclusion, Krankenberg said the use of the Luminexx nitinol stent reduced restenosis, improved target lesion revascularization 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 are safety analysis available,” commented Krankenberg.

The complete 12-month results will be announced at this year’s EuroPCR in Paris, France.

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