title: Evaluation of the biodegradable peripheral Igaki-Tamai stent in the treatment of de novo lesions in the superficial femoral artery: the GAIA study.
abstract: OBJECTIVE
  This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease.
  
  
  BACKGROUND
  Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery.
  
  
  METHODS
  A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events.
  
  
  RESULTS
  The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients.
  
  
  CONCLUSIONS
  The GAIA (Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral Artery) study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period.
authors: Center for Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany. Electronic address: office@drwerner.eu.
authors: Martin
authors: M
authors: Werner
authors: Cardiology Unit, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy.
authors: Antonio
authors: A
authors: Micari
authors: Cardiology Unit, Montevergine Clinic, Mercogliano, Italy.
authors: Angelo
authors: A
authors: Cioppa
authors: Cardiology Unit, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy.
authors: Giuseppe
authors: G
authors: Vadalà
authors: Center for Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany.
authors: Andrej
authors: A
authors: Schmidt
authors: Cardiovascular Center Frankfurt, Frankfurt, Germany.
authors: Horst
authors: H
authors: Sievert
authors: Cardiology Unit, Montevergine Clinic, Mercogliano, Italy.
authors: Paolo
authors: P
authors: Rubino
authors: Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
authors: Annalisa
authors: A
authors: Angelini
authors: Center for Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany.
authors: Dierk
authors: D
authors: Scheinert
authors: Cardiology Unit, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy.
authors: Giancarlo
authors: G
authors: Biamino
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000792:Angiography; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D016138:Walking
keywords: GAIA study; Igaki-Tamai; PLLA stent(s); biodegradable stent; peripheral artery disease; superficial femoral artery