Preliminary results after application of absorbable metal stents in patients with critical limb ischemia.

PURPOSE: To report the preliminary 3-month follow-up of a recently developed absorbable metal stent (AMS) for treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI).

METHODS: Between December 2003 and January 2004, 20 patients (10 men; mean age 76 years, range 59-96) with symptomatic critical limb ischemia (CLI) due to high-grade (80% to 100%) infrapopliteal stenoses received 1 or 2 AMS devices for suboptimal angioplasty. Clinical examination and color-flow duplex imaging were performed in all patients at discharge and at 1 and 3 months.

RESULTS: Angiographic procedural success was achieved in all 20 patients. One patient died (non-procedure-related) during the periprocedural period. Three months after the procedure, primary clinical patency was 89.5% (17/19). No major or minor amputation was necessary in any of the patients, yielding a limb salvage rate of 100%. The average improvement in Rutherford class was 2.3 at the 3-month assessment. A comparison of postprocedural and 1-month color-flow duplex ultrasound and magnetic resonance images clearly indicated the ongoing absorption process of the AMS.

CONCLUSIONS: After 3 months, the primary clinical patency and limb salvage rates suggest a potentially promising performance of these AMS devices in the treatment of below-knee lesions in CLI patients.