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SAN DIEGO -- Infrapopliteal application of sirolimus-eluting stents for critical limb ischemia reduced vascular restenosis and improved long-term angiographic patency compared with bare metal stents, a long-term, single-center study of more than 100 patients showed.

At 3 years' follow-up, the hazard ratio for binary restenosis in those patients receiving sirolimus-eluting stents was about one-third that of patients with bare metal stents, and the hazard ratio for primary patency was about five times as great in the sirolimus stent group, Dr. Konstantinos Katsanos reported at the annual meeting of the Society of Interventional Radiology.

He and his colleagues followed 103 patients with critical limb ischemia who underwent infrapopliteal revascularization with angioplasty and bail-out use of either sirolimus-eluting stents (SES) or bare metal stents (BMS).

Baseline below-the-knee angiogram of the CLI-affected limb (A); final angiogram after stenting (B); follow-up at 2 years (C). The clinical presentation of this same limb is shown to the right.

The patients were in a double-arm prospective registry. Their average age was 70 years. Patients received clopidogrel 75 mg/day and aspirin 100 mg/day for 6 months after the intervention.

Clinical evaluation was conducted 24-48 hours after the procedure; at 1, 3, and 6 months; and annually thereafter. Digital subtraction angiography was conducted 6 months, 1 year, and annually thereafter, and the images were read by two blinded independent radiologists.

Primary clinical and angiographic end points included mortality, limb salvage, primary patency, angiographic binary restenosis (defined as greater than 50%), and clinically driven target lesion reintervention rates.

Of the 103 patients, 41 were treated with SES (75 limbs with 153 lesions), and 62 were treated with BMS (46 limbs with 77 lesions), said Dr. Katsanos of the department of diagnostic and interventional radiology at Patras University Hospital, Rion, Greece.

Compared with the BMS group, patients in the SES group had a higher incidence of diabetes (87% vs. 76%, respectively), and a significantly larger stent lesion length (3.7 cm vs. 2.5 cm).

Baseline wound appearance of same limb shown in the angiograms at left (A, B, above). Complete wound healing occurred by 4 months after revascularization (C, D, above).

Follow-up data up to 3 years after the procedure showed that, compared with BMS-treated lesions, SES-treated lesions were associated with a significantly higher primary patency (hazard ratio 4.81), reduced binary restenosis (HR 0.38), and fewer repeat procedures because of recurrent clinical symptoms (HR 0.39).

However, no significant differences were observed between the SES and BMS groups in estimated 3-year patient mortality (29% vs. 32%, respectively), or in limb salvage (80% vs. 82%), he said.

The study was led by Dr. Katsanos's colleague Dr. Dimitris Siablis. Dr. Katsanos and Dr. Siablis had no conflicts related to the study.