Primary use of sirolimus-eluting stents in the infrapopliteal arteries.
OBJECTIVE
To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia.


METHODS
A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73+/-9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%+/-5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing > or =70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification.


RESULTS
Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6+/-0.4 at baseline to 0.8+/-0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3+/-0.8 at baseline to 0.9+/-1.1 (p<0.0001) after 1 year.


CONCLUSIONS
Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.
Rastan
Aljoscha
A
Heart-Center Bad Krozingen, Germany. aljoscha.rastan@herzzentrum.de
Schwarzwälder
Uwe
U
Noory
Elias
E
Taieb
Faical Haj
FH
Beschorner
Ullrich
U
Sixt
Sebastian
S
Bürgelin
Karlheinz
K
Amantea
Pietro
P
Neumann
Franz-Josef
FJ
Zeller
Thomas
T
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000295:instrumentation*; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D005858:Germany; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
D002317:Cardiovascular Agents; D020123:Sirolimus