Trial to evaluate modern stent technologies over balloon angioplasty for peripheral arterial disease

Apr 28 2005

The first patient undergoes treatment today in a new prospective randomised trial, called the SUPER Study, to compare stenting with balloon angioplasty in patients with superficial femoral artery (SFA) occlusions caused by peripheral artery disease (PAD).

The UK-based multicentre trial will compare patency rate at one year after percutaneous transluminal angioplasty (PTA) (where a catheter is passed into the arteries and the vessel is stretched by a balloon to increase blood flow) or stent placement with the Cordis Endovascular SMART nitinol self expandable.

Stents are expandable metal mesh tubes that are widely used in coronary, renal and iliac arteries. However, different properties are required in the femoral artery and results with older stent designs have been disappointing. Modern stent designs such as the Cordis SMART stent offer the flexibility and ability to recover from crushing required at this site and have a promising track record in this indication.

102,000 people are diagnosed with PAD each year in the UK and risk factors include age, smoking, hypertension, hyperlipidaemia, diabetes, and family history. PAD may be asymptomatic, but commonly presents with intermittent claudication - cramping pain on exercise - or pain at rest - due to reduced blood flow in the legs. In 3-6 per cent of cases complications arising through PAD lead to ulceration, and gangrene and amputation of the affected limb.

Current treatment options include disease management through lifestyle changes and medication, minimally invasive PTA or major surgery such as bypass grafts. PTA has lower morbidity, quicker recovery and reduced hospital stay compared with major surgery, however re-occlusion may occur within 6 to 24 months of treatment.

"Stenting has never gained widespread acceptance in the superficial femoral artery (SFA) due to the high rate of early reocclusion in previous series. New stent designs appear to give better mid-term patency rates and we are interested to find out whether or not there is appreciable benefit compared with balloon angioplasty alone, in those patients who have total occlusions (rather than simply narrowing) of the SFA," explains Dr Nick Chalmers, consultant vascular radiologist, Manchester Royal Infirmary, and co-principal investigator SUPER Study.

Comments Dr Mark Cowling, senior lecturer/ consultant interventional radiologist, University Hospital of North Staffordshire City General Hospital, co-principal investigator SUPER Study:

"PAD has a significant adverse effect on quality of life of up to 1000 patients per year in our local population. We are very excited that this trial may demonstrate a minimally invasive, cost effective and long-term solution to the pain and morbidity caused by PAD."

The clinical investigation of the SMART nitinol self expandable stent versus balloon angioplasty only for the treatment of superficial femoral artery occlusions - The SUPER study - is a multicentre prospective, randomised, two-arm study that will compare stenting versus ballooning in approximately 150 patients with symptomatic peripheral vascular disease with SFA occlusions across 12 UK centres. Patients will be followed for twelve months post procedure and the primary endpoint is primary patency at one year demonstrated by ultrasound.

Secondary objectives include the evaluation of clinical status and quality of life of the patient at discharge, three, six, nine and twelve months after the procedure, and evaluation of the cost effectiveness of both stenting and angioplasty.

Trial sponsor, Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through research, development and innovation, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.