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

Autor: José Carlos Ingrund, Norma Maria Tenório Brito Pires, Rafael Narciso Franklin, Daniel Mendes Pinto, Antonio Kambara, Caetano de Sousa Lopes, Koen Deloose, Gustavo Henrique Dumont Kleinsorge, Marco Rivera, Walter Khegan Karakhanian, Cristiano Torres Bortoluzzi, Jong Park, Felipe Nasser, Rodrigo Lopes, Adnan Neser, Douglas Cavalcanti, Roberto Augusto Caffaro, Marc Bosiers, André Mourão, Ilana Barros, Gilberto do Nascimento Galego, Alvaro Razuk, Pierre Galvagni Silveira, Leonardo Ghizoni Bez, Carlos Abath, Marcelo Calil Burihan
Rok vydání: 2015
Předmět:
Target lesion
Male
Time Factors
medicine.medical_treatment
02 engineering and technology
Femoral artery
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
0302 clinical medicine
Medicine
Prospective Studies
Aged
80 and over
Ultrasonography
Doppler
Duplex
Endovascular Procedures
Angiography
General Medicine
Middle Aged
Femoral Artery
Treatment Outcome
Female
Stents
Radiology
medicine.symptom
Cardiology and Cardiovascular Medicine
Brazil
Adult
medicine.medical_specialty
0206 medical engineering
Prosthesis Design
Disease-Free Survival
03 medical and health sciences
Peripheral Arterial Disease
medicine.artery
Alloys
Vascular Patency
Humans
Ankle Brachial Index
Aged
business.industry
Stent
Critical limb ischemia
medicine.disease
020601 biomedical engineering
Popliteal artery
Intermittent claudication
Surgery
Stenosis
business
Zdroj: The Journal of cardiovascular surgery. 58(3)
ISSN: 1827-191X
Popis: 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.
Databáze: OpenAIRE
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