Infrapopliteal stenting with silicon carbide-coated stents in critical limb ischemia: A 12 month follow-up study

Background: Critical limb ischemia is an increasingly common condition that has high surgical morbidity and limited non-surgical options. Objectives: To evaluate the use of silicon carbide-coated Motion stents, as compared to reported data for bare metal stents, in elderly patients with infrapopliteal artery stenoses causing critical limb ischemia after failed or complicated percutaneous transluminal angioplasty. Methods: Between January 2003 and March 2004, 41 stents were inserted into 17 consecutive patients (11 males, 6 females, mean age 82 years, range 75-93) following unsuccessful or complicated PTA. Seven patients had one-vessel run-off, six had two-vessel and four had three vessel run-off. All patients suffered from CLI, had up to three lesions and more than one co-morbid condition, and were considered at high surgical risk. Silicon carbide-coated Motion coronary stents, 2.5-4 mm diameter and 25 and 30 mm length, were used. Pre-intervention assessment included clinical condition, ankle brachial index, Doppler ultrasound and digital subtracted angiography. Post-intervention evaluation included clinical condition, ABI and Doppler ultrasound at 3, 6 and 12 months. Results: The technical success rate per lesion was 100% (41/41). Two patients died of unrelated causes after 2 and 8 months respectively. Primary patency rates with duplex ultrasound were 68.7% (11/16) at 3 months, 43.7% (7/16) at 6 months and 40% (6/15) after 12 months. Nine patients developed complete occlusion in 13 stents; three of these patients underwent a below-knee amputation and two patients a partial foot amputation. Re-intervention (PTA only) was performed in 7 patients (43.7%). Secondary patency rate was 81.2% (13/16) at 6 months and 60% (9/15) at one year. Mean ABI index had improved at 6 months from 0.32 to 0.67, and to 0.53 at one year. Clinical improvement was evident in 87.5% (14/16) at 6 months and in 66.6% (10/15) at one year. Conclusions: Silicon carbide-coated stents are comparable to bare metal stents after 6 and 12 months in infrapopliteal interventions in CLI when stenting is indicated.