Drug-Eluting and Bare Nitinol Stents for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery: Long-Term Results from the SIROCCO Trial

• Published in: Journal of endovascular therapy 2006-12, Vol.13 (6), p.701-710
• Main Authors: Duda, Stephan H., Bosiers, Marc, Lammer, Johannes, Scheinert, Dierk, Zeller, Thomas, Oliva, Vincent, Tielbeek, Alexander, Anderson, John, Wiesinger, Benjamin, Tepe, Gunnar, Lansky, Alexandra, Jaff, Michael R., Mudde, Catharina, Tielemans, Hans, Beregi, Jean-Paul
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - methods; Anti-Bacterial Agents; Atherosclerosis - complications; Atherosclerosis - diagnosis; Atherosclerosis - therapy; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - methods; Clinical trials; Coated Materials, Biocompatible; Double-Blind Method; Drug Carriers; Female; Femoral Artery; Fractures; Humans; Informed consent; Kaplan-Meier Estimate; Male; Medical imaging; Middle Aged; Patients; Physical examinations; Prospective Studies; Prosthesis Failure; Recurrence; Safety; Sirolimus; Standard deviation; Stents; Stents - adverse effects; Studies; Treatment Outcome
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/05-1704.1

Purpose: To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents. Methods: Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3±9.1 years, range 50–84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 ± 10.8 years, range 38–83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months. Results: Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups. Conclusion: These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.