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THE JOURNAL OF CARDIOVASCULAR SURGERY
Rivista di Chirurgia Cardiaca, Vascolare e Toracica
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,632
The Journal of Cardiovascular Surgery 2015 Mar 03
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
Nasser F. 1, Kambara A. 2, Abath C. 3, Cavalcanti D. 3, Barros I. 3, Pires N. 3, Rivera M. 3, Neser A. 1, Ingrund J. 1, Burihan M. 1, Silveira P. 4, Galego G. 4, Bortoluzzi C. 4, Franklin R. 4, Bosiers M. 5, Deloose K. 5, Razuk A. 6, Caffaro R. 6, Karakhanian W. K. 6, Park J. 6, Lopes C. 7, Pinto D. 7, Bez L. 7, Lopes R. 7, Mourão A. 7, Kleinsorge G. 7 ✉
1 Hospital Santa Marcelina, São Paulo, Brazil;
2 Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil;
3 Instituto de Medicina Integral 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
PURPOSE: 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, multi-center, 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 1 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%).
CONCLUSION: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.