Infrapopliteal application of sirolimus-eluting versus bare metal stents for critical limb ischemia: analysis of long-term angiographic and clinical outcome.
OBJECTIVE
To present the 3-year angiographic and clinical results of a prospective registry investigating the performance of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) for critical limb ischemia (CLI) treatment.


METHODS
A single-center double-arm prospective registry included patients with CLI who underwent infrapopliteal revascularization with angioplasty and "bailout" use of an SES or BMS. Clinical and angiographic follow-up was scheduled at regular time intervals. Primary clinical and angiographic endpoints included mortality, limb salvage, primary patency, binary angiographic restenosis (ie, >50%), and clinically driven repeat intervention-free survival. Results were stratified according to stent type, and cumulative proportion outcomes were determined by Kaplan-Meier plots. Multivariable Cox proportional-hazards regression analysis was applied to adjust for confounding factors of heterogeneity.


RESULTS
In total, 103 patients were included in the analysis; 41 (75.6% with diabetes) were treated with a BMS (47 limbs; 77 lesions) and 62 (87.1% with diabetes) with an SES (75 limbs; 153 lesions). At 3 years, SES-treated lesions were associated with significantly better primary patency (hazard ratio [HR], 4.81; 95% CI, 2.91-7.94; P < .001), reduced binary restenosis (HR, 0.38; 95% CI, 0.25-0.58; P < .001), and better repeat intervention-free survival (HR, 2.56; 95% CI, 1.30-5.00; P = .006) versus BMS-treated ones. No significant differences were identified between SESs and BMSs with regard to overall 3-year patient mortality (29.3% vs 32.0%; P = .205) and limb salvage (80.3% vs 82.0%; P = .507).


CONCLUSIONS
Infrapopliteal application of SESs for CLI significantly improves angiographic long-term patency and reduces infrapopliteal vascular restenosis versus BMSs, thereby lessening the rate of clinically driven repeat interventions.
Siablis
Dimitris
D
Department of Radiology, University Hospital of Patras, GR 265 00, Rion, Greece. siablis@med.upatras.gr
Karnabatidis
Dimitris
D
Katsanos
Konstantinos
K
Diamantopoulos
Athanasios
A
Spiliopoulos
Stavros
S
Kagadis
George C
GC
Tsolakis
John
J
D000368:Aged; D001807:Blood Vessel Prosthesis; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007269:Injections, Intra-Arterial; D007511:Ischemia / Q000000981:diagnostic imaging* / Q000628:therapy*; D007866:Leg / Q000098:blood supply* / Q000000981:diagnostic imaging*; D008137:Longitudinal Studies; D008297:Male; D008670:Metals; D011150:Popliteal Artery; D011859:Radiography; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D008670:Metals; D020123:Sirolimus