Sirolimus-eluting versus bare stents after suboptimal infrapopliteal angioplasty for critical limb ischemia: enduring 1-year angiographic and clinical benefit.
OBJECTIVE
To report the 1-year angiographic and clinical outcome from a prospective single-center study investigating the infrapopliteal application of sirolimus-eluting versus bare metal stents in patients with critical limb ischemia (CLI) who underwent below-the-knee endovascular revascularization.


METHODS
Stenting was performed as a bailout procedure for suboptimal angioplasty results (flow-limiting dissection, elastic recoil, or postangioplasty residual stenosis >30%). In the first 29 patients, infrapopliteal stenting was performed with bare metal stents (group B) and with sirolimus-eluting stents in the other 29 patients (group S).


RESULTS
Below-the-knee angioplasty and stenting involved 65 lesions in 40 infrapopliteal arteries of 29 limbs in group B and 66 lesions in 41 infrapopliteal arteries of 29 limbs in group S. Baseline comorbidities (hyperlipidemia and symptomatic cardiac and carotid disease) were more pronounced in group S (p<0.05). At 6 months, sirolimus-eluting stents demonstrated significantly higher primary patency (OR 5.625, 95% CI 1.711 to 18.493, p = 0.004) and decreased in-stent binary restenosis (OR 0.067, 95% CI 0.021 to 0.017, p<0.001) and in-segment binary restenosis (OR 0.229, 95% CI 0.099 to 0.533, p = 0.001). After 1 year, sirolimus-eluting stents were steadily associated with increased primary patency (OR 10.401, 95% CI 3.425 to 31.589, p<0.001) and significantly less in-stent (OR 0.156, 95% CI 0.060 to 0.407, p<0.001) and in-segment (OR 0.089, 95% CI 0.023 to 0.349, p = 0.001) binary restenosis. In addition, sirolimus-eluting stents were associated with significantly fewer cumulative target lesion reinterventions at 6 months (OR 0.057, 95% CI 0.008 to 0.426, p = 0.005) and 1 year (OR 0.238, 95% CI 0.067 to 0.841, p = 0.026). No significant differences between groups B and S were noted at 1 year with respect to mortality (10.3% versus 13.8%, respectively), minor amputation (17.2% versus 10.3%), or limb salvage (100% versus 96%).


CONCLUSIONS
The application of sirolimus-eluting stents reduces the restenosis rate in the infrapopliteal arteries and the rate of repeat endovascular procedures the first year after treatment.
Siablis
Dimitris
D
Department of Radiology (Angiography Suite), University Hospital of Patras, Rion, Greece. siablis@med.upatras.gr
Karnabatidis
Dimitris
D
Katsanos
Konstantinos
K
Kagadis
George C
GC
Kraniotis
Pantelis
P
Diamantopoulos
Athanassios
A
Tsolakis
John
J
D000368:Aged; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon; D002317:Cardiovascular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003251:Constriction, Pathologic / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008670:Metals; D016017:Odds Ratio; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012107:Research Design; D055502:Secondary Prevention; D020123:Sirolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency / Q000187:drug effects
D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus