Advanced search

Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study

Author
Organization
Abstract
Purpose:To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD). Methods: A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10-150). Results: A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8 +/- 0.8 (range 1-5) at baseline to 0.6 +/- 1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6 +/- 0.2 (range 0-1.4) at baseline to 0.9 +/- 0.2 (range 0-1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% Cl 84.9% to 95.2%) and 72.2% (95% Cl 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% Cl 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% Cl 4.0% to 14.4%). Conclusion: The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD. J Endovasc Ther. 2009;16:261-269
Keywords
occlusions, stenosis, restenosis, TRIAL, stent fracture, outcome analysis, ANGIOPLASTY, peripheral artery disease, superficial femoral artery

Citation

Please use this url to cite or link to this publication:

Chicago
Bosiers, Marc, Giovanni Torsello, Hans-Martin Gissler, Johannes Ruef, Stefan Muller-Hulsbeck, Thomas Jahnke, Patrick Peeters, et al. 2009. “Nitinol Stent Implantation in Long Superficial Femoral Artery Lesions: 12-month Results of the DURABILITY I Study.” Journal of Endovascular Therapy 16 (3): 261–269.
APA
Bosiers, Marc, Torsello, G., Gissler, H.-M., Ruef, J., Muller-Hulsbeck, S., Jahnke, T., Peeters, P., et al. (2009). Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. JOURNAL OF ENDOVASCULAR THERAPY, 16(3), 261–269.
Vancouver
1.
Bosiers M, Torsello G, Gissler H-M, Ruef J, Muller-Hulsbeck S, Jahnke T, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. JOURNAL OF ENDOVASCULAR THERAPY. 2009;16(3):261–9.
MLA
Bosiers, Marc, Giovanni Torsello, Hans-Martin Gissler, et al. “Nitinol Stent Implantation in Long Superficial Femoral Artery Lesions: 12-month Results of the DURABILITY I Study.” JOURNAL OF ENDOVASCULAR THERAPY 16.3 (2009): 261–269. Print.
@article{1022620,
  abstract     = {Purpose:To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD).
Methods: A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10-150).
Results: A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8 +/- 0.8 (range 1-5) at baseline to 0.6 +/- 1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6 +/- 0.2 (range 0-1.4) at baseline to 0.9 +/- 0.2 (range 0-1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% Cl 84.9% to 95.2%) and 72.2% (95% Cl 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% Cl 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% Cl 4.0% to 14.4%).
Conclusion: The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD. J Endovasc Ther. 2009;16:261-269},
  author       = {Bosiers, Marc and Torsello, Giovanni and Gissler, Hans-Martin and Ruef, Johannes and Muller-Hulsbeck, Stefan and Jahnke, Thomas and Peeters, Patrick and Daenens, Kim and Lammer, Johannes and Schroe, Herman and Mathias, Klaus and Koppensteiner, Renate and Vermassen, Frank and Scheinert, Dierk},
  issn         = {1526-6028},
  journal      = {JOURNAL OF ENDOVASCULAR THERAPY},
  keywords     = {occlusions,stenosis,restenosis,TRIAL,stent fracture,outcome analysis,ANGIOPLASTY,peripheral artery disease,superficial femoral artery},
  language     = {eng},
  number       = {3},
  pages        = {261--269},
  title        = {Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study},
  url          = {http://dx.doi.org/10.1583/08-2676.1},
  volume       = {16},
  year         = {2009},
}

Altmetric
View in Altmetric
Web of Science
Times cited: