Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the Femoral Artery Conformexx Trial (FACT).
OBJECTIVE
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 <10 cm long treated with the self-expanding nitinol Conformexx stent. The primary study endpoint was binary restenosis determined by duplex ultrasound at 12 months. Secondary 12-month endpoints were target lesion revascularization (TLR), ankle-brachial index (ABI), mean Rutherford category, >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<0.0001); 85.1% were improved by at least 1 Rutherford category. The ABI increased from 0.62+/-0.15 to 0.85+/-0.20 (p<0.0001).


CONCLUSIONS
This study of patients with SFA lesions documented favorable outcomes using nitinol stents in TASC-II A or B lesions after 1 year. The study was underpowered to prove superiority of the Conformexx nitinol stent design compared to historical balloon only or Luminexx 3 stent groups.
Zeller
Thomas
T
Department of Angiology, Herz-Zentrum Bad Krozingen, Germany. thomas.zeller@herzzentrum.de
Tiefenbacher
Christiane
C
Steinkamp
Hermann J
HJ
Langhoff
Ralf
R
Wittenberg
Günther
G
Schlüter
Michael
M
Buergelin
Karlheinz
K
Rastan
Aljoscha
A
Krumsdorf
Ulrike
U
Sixt
Sebastian
S
Schulte
Carl-Ludwig
CL
Tübler
Thilo
T
Krankenberg
Hans
H
D000368:Aged; D000497:Alloys; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D006801:Humans; D008297:Male; D016491:Peripheral Vascular Diseases / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D015607:Stents; D016896:Treatment Outcome; D014463:Ultrasonography; D014654:Vascular Patency
D000497:Alloys; C013616:nitinol