Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial.
BACKGROUND
The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA).


METHODS
From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months.


RESULTS
Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%).


CONCLUSIONS
In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.
Santa Marcelina Hospital, São Paulo, Brazil.
Felipe
F
Nasser
Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.
Antonio
A
Kambara
Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil.
Carlos
C
Abath
Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil.
Douglas
D
Cavalcanti
Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil.
Ilana
I
Barros
Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil.
Norma
N
Pires
Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil.
Marco
M
Rivera
Santa Marcelina Hospital, São Paulo, Brazil.
Adnan
A
Neser
Santa Marcelina Hospital, São Paulo, Brazil.
Jose
J
Ingrund
Santa Marcelina Hospital, São Paulo, Brazil.
Marcelo
M
Burihan
Baía Sul Medical Center, CORIS, Florianópolis, Brazil.
Pierre
P
Silveira
Baía Sul Medical Center, CORIS, Florianópolis, Brazil.
Gilberto
G
Galego
Baía Sul Medical Center, CORIS, Florianópolis, Brazil.
Cristiano
C
Bortoluzzi
Baía Sul Medical Center, CORIS, Florianópolis, Brazil.
Rafael
R
Franklin
Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium - office@fmrp.be.
Marc
M
Bosiers
Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.
Koen
K
Deloose
Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil.
Alvaro
A
Razuk
Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil.
Roberto
R
Caffaro
Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil.
Walter K
WK
Karakhanian
Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil.
Jong
J
Park
Hospital Felício Rocho, Belo Horizonte, Brazil.
Caetano
C
Lopes
Hospital Felício Rocho, Belo Horizonte, Brazil.
Daniel
D
Pinto
Hospital Felício Rocho, Belo Horizonte, Brazil.
Leonardo
L
Bez
Hospital Felício Rocho, Belo Horizonte, Brazil.
Rodrigo
R
Lopes
Hospital Felício Rocho, Belo Horizonte, Brazil.
André
A
Mourão
Hospital Felício Rocho, Belo Horizonte, Brazil.
Gustavo
G
Kleinsorge
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000792:Angiography; D055109:Ankle Brachial Index; D001938:Brazil; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
D000497:Alloys; C013616:nitinol