Author + information
- Received September 16, 2013
- Accepted September 26, 2013
- Published online March 1, 2014.
- Martin Werner, MD∗∗ (, )
- Antonio Micari, MD, PhD†,
- Angelo Cioppa, MD‡,
- Giuseppe Vadalà, MD†,
- Andrej Schmidt, MD∗,
- Horst Sievert, MD§,
- Paolo Rubino, MD‡,
- Annalisa Angelini, MD‖,
- Dierk Scheinert, MD∗ and
- Giancarlo Biamino, MD, PhD†
- ∗Center for Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany
- †Cardiology Unit, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy
- ‡Cardiology Unit, Montevergine Clinic, Mercogliano, Italy
- §Cardiovascular Center Frankfurt, Frankfurt, Germany
- ‖Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy
- ↵∗Reprint requests and correspondence:
Dr. Martin Werner, Center for Vascular Medicine, Park Hospital Leipzig, Strümpellstrasse 41, 04289 Leipzig, Germany.
Objectives 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.
- biodegradable stent
- GAIA study
- peripheral artery disease
- PLLA stent(s)
- superficial femoral artery
Drs. Werner, Angelini, and Biamino have worked as consultants for Kyoto Medical. Dr. Sievert has received honoraria, travel expenses, or consulting fees from Abbott, Access Closure, AGA, Angiomed, Aptus, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Cardiac Dimensions, CardioKinetix, CardioMEMS, Coherex, Contego, Covidien, CSI, CVRx, EndoCross, ev3, FlowCardia, Gardia, Gore, Guided Delivery Systems, InSeal Medical, Lumen Biomedical, HLT, Lifetech, Lutonix, Maya Medical, Medtronic, NDC, Occlutech, Osprey, Ostial, PendraCare, Pfm Medical, Recor, ResMed, Rox Medical, SentreHeart, Spectranetics, SquareOne, Trireme, Trivascular, Venus Medical, Veryan, and Vessix; has received grant research support from Cook, St. Jude Medical; and has stock options with Cardiokinetix, Access Closure, Velocimed, Lumen Biomedical, Coherex, and SMT. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 16, 2013.
- Accepted September 26, 2013.
- American College of Cardiology Foundation