Thank you very much. My name is Naoki Hayakawa at Asahi General Hospital, Japan. It's great for me to be here, and today my topic is the LINC 2025: EAGLE-study. We presented the EAGLE-study, conducted as three-year drug-coated balloon treatment for femoropopliteal CTO.

What are the unmet needs for DCB-treatment of FP CTOs?

We have many accumulated experiences in successfully treating FP-CTO with DCBs. However, many curriculum studies perform the DCB with bailout stent. So our clinical question is, is DCB strategy for femoropopliteal CTO feasible? This is an unmet need of the FP-CTO lesion.

What was the study design and patient population?

We conducted this study from our Eastern Japanese and seven cardiovascular centres: BEASTARS registry. And we conducted a multicentre, non-randomized study examining 359 consecutive lesions in under 318 patients with symptomatic femoropopliteal chronic total occlusive lesions treated with drug-coated balloon from April 2017 to February 2021.

What were the key findings?

And the 12 month clinical outcome of the EAGLE-study we already published. From this study, the 12 month primary patency was about 80%, and the 12 month freedom from CD-TLR was about 86%, and freedom from reocclusion was 88%. Very acceptable.

However, we analysed based on the accumulation of the restenosis risk factors. From this study, the independent risk factors for the patency loss were the four factors: hemodialysis patient, CLTI patient and restenotic lesions and no use of DAPT — dual antibiotic therapy. If there are no factor patient, 12 months primary patency was 90%. However, the more factor, more factor means over two factors patient, 12 months primary patency was 66%.

So this study we conducted three years, the purpose of the three years follow-up study was to present clinical outcomes and the results stratified by each risk factor of the 12 month restenosis. From this study, the three month primary patency was about 52% and the three years freedom from CD-TLR was about 62%. And the three years clinical outcome based on the accumulation of the restenosis risk factors, for the no-factor patients, three years primary patency was over 65%.

However, for the more-factor patient, the prime patency was under 30%. And the TLR components: 65% were the balloon angioplasty and 59% was the DCB angioplasty. However, the 32% was a scaffold device using. However, surgical conversion was only 1.6%. And the three years freedom from reocclusion and freedom from ALI was a very high: for reocclusion was 77% and freedom from ALI was 96%.

What are the take-home messages for practice?

So the clinical results of DCB for FP-CTO were in the feasible range. However, the three year patency was low in patients with many risk factors. The risk factor means the CLTI, hemodialysis and restenosis lesions and no DAPT use patient. And the patient without restenosis factors one year could achieve acceptable three year patency and acceptable three year clinical outcome for freedom from CD-TLR and recoclussion and ALI.

What further research is needed in this area?

So we conducted this study, and [illegible] at the beginning of the use of DCB in Japan. And the atherectomy device was not used during this study period. So it is possible that the techniques used to improve the result of DCB were still emergent. So there and it is necessary to conduct further, larger-scale, up to date techniques and up to date research in the future. Thank you for your kind attention.