TCT: Stent for Claudication Shows Efficacy and Durability

WASHINGTON, Oct. 24 -- Claudication patients given an investigational self-expanding stent were significantly more likely to maintain vessel patency at 12 months than those treated with percutaneous transluminal angioplasty alone.
At 12 months, 80% of the stented patients in the RESILIENT II trial had maintained primary patency versus 38% of the controls and 87% did not require target lesion revascularization versus 46% of controls (P<0.0001 for both), said Barry T. Katzen, M.D., of the Baptist Cardiac and Vascular Institute in Miami.
"In claudication patients with lesions shorter than 150 mm, primary stenting is superior to percutaneous transluminal angioplasty alone as evidenced by a larger luminal diameter, lesion success, procedural success, and durable results," Dr. Katzen said at the Transcatheter Cardiovascular Therapeutics meeting here.
Stenting for peripheral arterial disease has not achieved the same success as coronary or carotid stenting largely because earlier stent designs were not well suited to stress created by movement and load-bearing in the leg.
But Dr. Katzen said the self-expanding Nitinol stent (Edwards LifeStent) was ideally suited to the femoral artery because it is both flexible and durable.
The RESILIENT II trial enrolled 206 patients at 24 sites. All patients had lesions of less than 150 mm located in the superficial femoral artery or the proximal popliteal artery. Sixty-nine patients were randomized to percutaneous transluminal angioplasty alone and 137 to angioplasty plus stenting.

The primary endpoint was target lesion revascularization or target vessel revascularization at six months. Secondary endpoints were patency, lesion, procedure and clinical success, and quality of life assessed by a walking impairment questionnaire (in the stenting arm alone).
Among the findings:
There were no differences in one-year freedom from major adverse cardiovascular events (MACE).
The clinical success rate was 72% in the stent arm, 34% in the percutaneous transluminal angioplasty alone arm (P<0.0001).
At 12 months just over 60% of the stented patients said they could walk without pain versus about 35% at baseline. Stent patients reported similar improvements in pain-free stair climbing, and ability to walk for longer distances and walk faster compared with baseline.
The study was funded by Edwards Lifesciences, which is seeking FDA approval for the LifeStent. Dr. Katzen disclosed support from Edwards Lifesciences.Additional source: Transcatheter Cardiovascular TherapeuticsSource reference: Katzen BT, "The RESILIENT Trial, 12-Month Anlaysis" Late-breaking clinical trials.