From the LANDMARK registry, there was no significant difference in 2-year primary patency rates after treatment of femoral popliteal artery lesions with Lutonix, a coated balloon (DCB) using low-dose paclitaxel, and IN. PACT Admiral, a DCB using high-dose paclitaxel, according to a presentation by Dr. Shinsuke Mori of the Saiseikai Yokohama City Eastern Hospital at the Speaker’s Corner Session of LINC 2022.
Comparison of Clinical Outcome between Low-dose and High-dose Paclitaxel Drug-coated Balloon in Endovascular Therapy for Femoropopliteal Lesion: LANDMARK Registry
In this study, of 1,378 patients (1,777 lesions) who underwent EVT for femoral popliteal artery lesions between July 2017 and June 2020 at five Kanagawa Prefecture centers enrolled in the LANDMARK registry. Of those, 214 patients (214 lesions) were treated with Lutonix DCB (paclitaxel dose 2.0µg/mm2) and 263 patients (263 lesions) were treated with IN.PACT Admiral DCB (paclitaxel dose 3.5µg/mm2). They were included to compare clinical outcomes in 156 propensity-matched pairs.
Patient background after propensity matching was similar, with a mean age of approximately 74 years, approximately 67% male, diabetes mellitus in 63%, dialysis in 39%, and CLTI in approximately 34%. Lesion characteristics included approximately 79% de novo lesions, mean reference diameter of 5.4 mm, mean lesion length of 15 cm. TASC II C/D lesions, CTO lesions, and PACSS 3/4 with calcified lesions accounted for approximately 46%, 30%, and 42%, respectively.
The 2-year primary patency rates were 73% and 72% in the Lutonix and IN.PACT groups, respectively (p=0.60), while the 2-year TLR free rates were 76% and 75%, respectively (p=0.67). In the subgroups of CTO lesions, CLTI patients, TASC II C/D lesions, and highly calcified lesions, there were no significant differences in the primary patency rates.
Multivariate analysis showed that predictors of restenosis included dialysis (HR 2.33 [95%CI 1.54-3.52] p<0.0001), restenotic lesions (HR 1.71 [95%CI 1.12-2.58] p=0.0142), lesions with popliteal involvement (HR 1.56 [95%CI 1.03-2.37] p=0.0371) , poor run off (HR 1.55 [95%CI 1.05-2.30] p=0.0276), and DCB diameter (HR 0.76 [95%CI 0.59-0.99] p=0.0416).
Dr. Mori stated, "There were no significant differences in clinical outcomes after treatment with low-dose or high-dose DCB for femoral popliteal artery lesions. Dialysis, restenotic lesions, popliteal lesions, poor run off, and DCB diameter were identified as predictors of restenosis," he concluded.
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