Nitinol Stent Implantation in TASC A and B Superficial Femoral Artery Lesions: The Femoral Artery Conformexx Trial (FACT)
Purpose: To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST). Methods: Between January 2004 and August 2005, 6 stu...
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Veröffentlicht in: | Journal of endovascular therapy 2008-08, Vol.15 (4), p.390-398 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | Purpose:
To investigate the impact of nitinol stenting of superficial femoral artery (SFA) lesions with a maximum length of 10 cm (TASC-II A or B) on 1-year outcomes compared to a historical study cohort from the Femoral Artery Stent Trial (FAST).
Methods:
Between January 2004 and August 2005, 6 study sites enrolled 110 symptomatic patients (75 men; mean age 68±9 years) with a single de novo >70% SFA lesion 1-class change in Rutherford category, and major adverse events. Data were analyzed according to the intention-to-treat principle and according to the actual treatment received (“on treatment” analysis). Outcomes were compared to the historical balloon angioplasty (BA) arm and the Luminexx 3 stent arm of the randomized FAST study.
Results:
Technical success was achieved in 106 (96%) patients; at 1 year, the primary endpoint of ultrasound-assessed binary restenosis was reached in 14 (23.3%) of 60 patients (95% CI 13.4% to 36%). This restenosis rate was lower versus the historical BA (38.6%, p=0.057) or Luminexx 3 stent controls (31.7%, p=0.284) from FAST. The clinically driven TLR was 7.4% (7 of 94 clinically controlled patients), which was also lower compared to 18.3% (p=0.098) and 14.9% (p=0.267) for the historical BA and Luminexx 3 stent groups, respectively. The mean Rutherford category was reduced from 2.75±0.79 to 0.94±1.38 (p |
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ISSN: | 1526-6028 1545-1550 |
DOI: | 10.1583/08-2461.1 |