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ORIGINAL ARTICLE  VASCULAR SECTION 

The Journal of Cardiovascular Surgery 2017 June;58(3):409-15

DOI: 10.23736/S0021-9509.16.08471-8

Copyright © 2015 EDIZIONI MINERVA MEDICA

language: English

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

Felipe NASSER 1, Antonio KAMBARA 2, Carlos ABATH 3, Douglas CAVALCANTI 3, Ilana BARROS 3, Norma PIRES 3, Marco RIVERA 3, Adnan NESER 1, Jose INGRUND 1, Marcelo BURIHAN 1, Pierre SILVEIRA 4, Gilberto GALEGO 4, Cristiano BORTOLUZZI 4, Rafael FRANKLIN 4, Marc BOSIERS 5, Koen DELOOSE 5, Alvaro RAZUK 6, Roberto CAFFARO 6, Walter K. KARAKHANIAN 6, Jong PARK 6, Caetano LOPES 7, Daniel PINTO 7, Leonardo BEZ 7, Rodrigo LOPES 7, André MOURÃO 7, Gustavo KLEINSORGE 7

1 Santa Marcelina Hospital, São Paulo, Brazil; 2 Dante Pazzanese Institute of Cardiology, São Paulo, Brazil; 3 Institute of Integrative Medicine Professor Fernando Figueira (IMIP), Recife, Brazil; 4 Baía Sul Medical Center, CORIS, Florianópolis, Brazil; 5 Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium; 6 Irmandade da Santa Case de Mesericórdia, São Paulo, Brazil; 7 Hospital Felício Rocho, Belo Horizonte, Brazil


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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.


KEY WORDS: Peripheral arterial disease - Endovascular Procedures - Stents - Femoral Artery

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