Primary Use of Sirolimus-Eluting Stents in the Infrapopliteal Arteries

• Published in: Journal of endovascular therapy 2010-08, Vol.17 (4), p.480-487
• Main Authors: Rastan, Aljoscha, Schwarzwälder, Uwe, Noory, Elias, Taieb, Faical Haj, Beschorner, Ullrich, Sixt, Sebastian, Bürgelin, Karlheinz, Amantea, Pietro, Neumann, Franz-Josef, Zeller, Thomas
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Angioplasty, Balloon - instrumentation; Ankle Brachial Index; Arterial Occlusive Diseases - complications; Arterial Occlusive Diseases - diagnosis; Arterial Occlusive Diseases - physiopathology; Arterial Occlusive Diseases - therapy; Blood clots; Cardiovascular Agents - administration & dosage; Cardiovascular disease; Chronic Disease; Constriction, Pathologic; Disease-Free Survival; Drug therapy; Drug-Eluting Stents; Female; Germany; Humans; Intervention; Ischemia; Ischemia - diagnosis; Ischemia - etiology; Ischemia - physiopathology; Ischemia - therapy; Kaplan-Meier Estimate; Logistic Models; Lower Extremity - blood supply; Male; Medical imaging; Middle Aged; Mortality; Odds Ratio; Popliteal Artery - diagnostic imaging; Popliteal Artery - physiopathology; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Registries; Regression analysis; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus - administration & dosage; Stents; Studies; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Wound healing
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/10-3073.1

Purpose: 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 ≥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