Value of drug-eluting stents after failed percutaneous transluminal angioplasty in the infrapopliteal vessels for the treatment of critical limb ischemia: favorable mid-term patency and limb salvage results.

AIM

The endovascular treatment of infrapopliteal arterial disease in the setting of critical limb ischemia (CLI) is increasing in use. In patients in whom percutaneous transluminal angioplasty (PTA) resulted in suboptimal angiographic results, flow limiting dissection or re-coil is thought to limit clinical success. This single-center experience examines the angiographic and clinical results when Drug-Eluting Stents (DES) were placed in a large cohort of patients with CLI after immediate infrapopliteal PTA failure.

METHODS

A retrospective review of a prospectively collected single-center endovascular database was performed. Sixty-seven Rutherford grade 4, 5, and 6 patients were treated between October 2005 and February 2010 with PTA because lack of an acceptable autologous vein for bypass-grafting or severe medical comorbidities precluded them from surgical bypass. The study cohort had suboptimal angiographic results immediately after PTA that was subsequently treated with DES. Patients were then placed on clopidogrel and aspirin indefinitely. Angiographic, clinical, and the results of noninvasive vascular examinations were collected.

RESULTS

In total, 123 stents (94 sirolimus, 27 everolimus, 2 paclitaxel) were placed in 67 patients to treat a total of 84 angiographic lesions. Simultaneous femoral-popliteal intervention was performed in 66% of the patients while 45% of the treated lesions were total occlusions. Lesion length ranged from 17 mm-142 mm (mean 50 mm). Initial technical success was 100%, with all 84 lesions being treated successfully with less than 10% stenosis after stent implantation. Mean follow-up was 20 months (1-42 months) with 6, 12, and 24-month primary patency rates of 90%, 86%, and 72% respectively. Freedom from major amputation was 91.1% (61/67) with all six amputations occurring in the Rutherford grade 6 group (6/11). Overall mortality rate was 19% (13/67) with one death occurring within 30 days.

CONCLUSION

The use of drug-eluting stents following suboptimal PTA for the treatment of infrapopliteal arterial disease in this cohort of patients with CLI produced high primary patency and limb salvage rates supporting the efficacy of this treatment strategy.