Prospective, randomised, multicentre comparison of balloon angioplasty and the Cypher Select Plus stent for patients with ischaemic infrapopliteal disease shows that the stent is superior to angioplasty.
Konstantinos Katsanos, Department of Radiology, University Hospital of Patras, Rion, Greece, presented the results at the CIRSE 2011 conference in Munich, Germany.
The ACHILLES study was designed to compare the performance of a drug-eluting stent (Cypher Select Plus stent from Cordis which is a sirolimus-eluting stent) to balloon angioplasty in de novo and restenotic native infrapopliteal arterial lesions using an angiographic primary endpoint. Percutaneous balloon angioplasty is the current endovascular standard of care.
Several single-centre studies have shown the safety and efficacy of the sirolimus-eluting stent in lesions below the knee and the Cypher Select Plus stent received CE mark approval in 2006 for use in infrapopliteal arteries. Ischaemic infrapopliteal arterial disease limits blood flow below the knee causing pain, skin ulcers or sores, and an increased risk of amputation. The investigators randomised 200 patients with infrapopliteal artery disease who had two, or fewer, lesions with over 70% stenosis, and a maximum lesion length of 120mm to stenting or percutaneous transluminal angioplasty at 16 institutions in Europe.
The maximum number of stents per patient was fixed at four. The primary endpoint was angiographic in-segment binary restenosis at one year follow-up as determined by quantitative vessel analysis. Secondary endpoints included device, lesion and procedure success, mean percent diameter stenosis, minimal lumen diameter and late loss at 12 months and target lesion revascularisation, target vessel revascularisation and amputations at six weeks, six and 12 months.
Katsanos told delegates, “The study randomised 99 patients (113 lesions) to stenting and 101 patients (115 lesions) to percutaneous transluminal angioplasty. Baseline lesion characteristics were similar. The total lesion length was 26.9mm in the stenting group and 26.8mm in the angioplasty group.”
He explained that crossover from the angioplasty group to the stenting group occurred in eight patients. He noted that all the 99 patients randomised to the stent group had no change in plan and received a sirolimus-eluting stent.
The primary endpoint of angiographic binary restenosis at 12 months was reached by 22.4% in the drug-eluting stent group and 41.9% in the angioplasty group (p=0.019) analysed on an intention-to-treat basis and by 21.3% in the stent group versus 45.5% (p=0.004) analysed “as treated”.
Of further interest, the secondary endpoint of complete wound healing was marginally improved as adjudicated by an independent clinical reviewer, who was blinded to assigned treatment. Complete wound healing was recorded by 72.3% in the drug-eluting stent group versus 56.5% in the angioplasty group (p=0.13) on an intention-to-treat basis and by 72.9% in the drug-stent group versus 55.6% in the control group (p=0.09) analysed “as treated”.
“The Achilles study reached its primary endpoint, angiographic binary restenosis and demonstrated the superiority of the Cypher stent over angioplasty in native infrapopliteal artery lesions,” Katsanos concluded.