PMID- 36201088 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221010 IS - 2520-8934 (Electronic) IS - 2520-8934 (Linking) VI - 5 IP - 1 DP - 2022 Oct 6 TI - Clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter EAGLE study. PG - 51 LID - 10.1186/s42155-022-00329-8 [doi] LID - 51 AB - BACKGROUND: Several studies have reported the efficacy of drug-coated balloons (DCB) for simple femoropopliteal (FP) lesions. However, the effectiveness of DCB for FP chronic total occlusive lesions (CTO) is controversial. The present study investigated the clinical outcomes of DCB for FP-CTO. MATERIALS AND METHODS: We retrospectively analyzed 359 limbs of 318 patients who underwent endovascular therapy with DCB for FP-CTO between July 2017 and February 2021 at seven cardiovascular centers. The primary endpoint was 12-month primary patency. The secondary endpoints were the 12-month rates of freedom from: (1) clinically-driven target lesion revascularization (CD-TLR), and (2) re-occlusion. The association of baseline characteristics with the 12-month restenosis risk was investigated using the Cox proportional hazards regression model. RESULTS: The 12-month rate of primary patency was 79.8% (95% confidence interval [95%CI], 75.1% to 84.8%), whereas the corresponding rates of freedom from CD-TLR and re-occlusion were 86.4% (95%CI: 82.6% to 90.4%) and 88.5% (95%CI: 84.7% to 92.4%), respectively. The bailout stent rate was 8.9%. Independent risk factors for restenosis were hemodialysis (adjusted hazard ratio, 2.18 [1.39 to 3.45]; P = 0.001), chronic limb-threatening ischemia (CLTI) (2.02 [1.33 to 3.07]; P = 0.001), and restenosis lesion (2.02 [1.32 to 3.08]; P = 0.001). Use of dual antiplatelet therapy (DAPT) was identified as a protective factor for restenosis (0.54 [0.35 to 0.82]; P = 0.003). CONCLUSIONS: Despite the low rate of bailout stent, DCB treatment for FP-CTO was effective in real-world clinical practice. Hemodialysis, CLTI, and restenosis lesion were independent risk factors for 12-month restenosis, and the use of DAPT significantly attenuated the risk of 12-month restenosis. CI - (c) 2022. The Author(s). FAU - Hayakawa, Naoki AU - Hayakawa N AUID- ORCID: 0000-0002-4168-2808 AD - Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan. haya.naoki1981@gmail.com. FAU - Takahara, Mitsuyoshi AU - Takahara M AD - Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan. FAU - Nakama, Tatsuya AU - Nakama T AD - Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan. AD - Division of Vascular Surgery, Department of Surgery, Jikei University School of Medicine, Tokyo, Japan. FAU - Horie, Kazunori AU - Horie K AD - Department of Cardiovascular Medicine, Sendai Kousei Hospital, Sendai, Japan. FAU - Takanashi, Keisuke AU - Takanashi K AD - Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan. FAU - Kanagami, Teruaki AU - Kanagami T AD - Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan. FAU - Ichihara, Shinya AU - Ichihara S AD - Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan. FAU - Arakawa, Masataka AU - Arakawa M AD - Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan. FAU - Tobita, Kazuki AU - Tobita K AD - Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan. FAU - Mori, Shinsuke AU - Mori S AD - Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. FAU - Iwata, Yo AU - Iwata Y AD - Department of Cardiology, Funabashi Municipal Medical Center, Funabashi, Japan. FAU - Suzuki, Kenji AU - Suzuki K AD - Department of Cardiology, Tokyo Saiseikai Central Hospital, Tokyo, Japan. FAU - Kanda, Junji AU - Kanda J AD - Department of Cardiovascular Medicine, Asahi General Hospital, I-1326 Asahi, Chiba, 289-2511, Japan. LA - eng PT - Journal Article DEP - 20221006 PL - Switzerland TA - CVIR Endovasc JT - CVIR endovascular JID - 101738484 PMC - PMC9537392 OTO - NOTNLM OT - Chronic total occlusive lesion OT - Drug-coated balloon OT - Endovascular therapy OT - Femoropopliteal occlusive disease COIS- TN is a consultant of Boston Scientific, BD, Cordis, Century Medical Inc., COOK Medical, Kaneka Medix, NIPRO, OrbusNeichi, Medtronic, and TERUMO Corporation. KS received remuneration for lectures from Boston Scientific Japan, and consultant fees from Medtronic. KT is a consultant of Gore and received a speakers fee from Medtronic. The other authors report no conflicts of interest. EDAT- 2022/10/07 06:00 MHDA- 2022/10/07 06:01 PMCR- 2022/10/06 CRDT- 2022/10/06 11:16 PHST- 2022/07/05 00:00 [received] PHST- 2022/09/29 00:00 [accepted] PHST- 2022/10/06 11:16 [entrez] PHST- 2022/10/07 06:00 [pubmed] PHST- 2022/10/07 06:01 [medline] PHST- 2022/10/06 00:00 [pmc-release] AID - 10.1186/s42155-022-00329-8 [pii] AID - 329 [pii] AID - 10.1186/s42155-022-00329-8 [doi] PST - epublish SO - CVIR Endovasc. 2022 Oct 6;5(1):51. doi: 10.1186/s42155-022-00329-8.