Original title: Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatmentof De Novo Lesions in the Superficial Femoral Artery. The GAIA Study. Reference: Martin Werner et al. J Am Coll Cardiol Intv 2014;7:305–12.

The aim of this study was to assess the safety and efficacy of the biodegradable stent Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) in patients with occlusive superficial femoral artery disease. Polylactic acid biodegradable stents have been shown to be effective in coronary territory but there are no data for the superficial femoral artery.

A prospective study enrolled 30 patients with symptomatic de novo superficial femoral artery lesions receiving the bioresorbable Igaki-Tamai stent. Clinical follow up was performed with Doppler at months 6, 9 and 12. The study endpoints were technical success, restenosis rate, lesion revascularization rate, changes in ankle brachial index, and improved quality of life.

The mean lesion length was 5.9 cm and the mean diameter stenosis was reduced from the original 89.9% to 6.2%. Binary restenosis rate for the 6 and 12 month follow up was 39.3% and 67.9% respectively with a lesion revascularization rate of 25% and 57.1% respectively. All new revascularizations were successful with a secondary patency rate of 89.3% at 12 months.

Conclusion

The GAIA study (Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral Artery) showed that the use of bioresorbable stents has an immediate result similar to bare metal stents but with a high rate of revascularization at 12 months. Stent design and implantation technique both call for enhancement to reduce restenosis during reabsorption period. 

Editorial Comment

The absence of a control group is one of the limitation of this study, which lacks direct comparison to another device. Systematic follow up with Doppler could have exaggerated revascularization rates, not always justified by clinical outcomes. 

SOLACI