Kohei Yamaguchi, Hirokazu Miyashita, Masanaga Tsujimoto, Shinya Ichihara, Shinsuke Mori, Kazuki Tobita, Takuya Haraguchi, Naoki Hayakawa
No statistically significant differences in angiographic or 1-year clinical outcomes were observed between low-dose and high-dose drug-coated balloons in propensity score-matched patients.
PURPOSE: Jetstream atherectomy is commonly used to prepare severely calcified femoropopliteal lesions; however, the optimal choice between low- and high-dose drug-coated balloons after atherectomy remains unclear.
MATERIALS AND METHODS: We analyzed data from multicenter JOKER registry. We identified patients with symptomatic lower-extremity artery disease who underwent Jetstream atherectomy followed by DCB angioplasty for severely calcified femoropopliteal lesions between November 2022 and December 2024. Patients were classified into the low-dose drug-coated balloon group, treated with Ranger, and the high-dose drug-coated balloon group, treated with IN.PACT Admiral. Propensity score matching was used for adjustment for clinical and lesion characteristics. The primary endpoint was 1-year primary patency.
RESULTS: Of 219 patients, 136 were treated with low-dose drug-coated balloon and 83 with high-dose drug-coated balloon. Propensity score matching generated 66 matched pairs. In the matched cohort, flow impairment after Jetstream atherectomy did not differ significantly between the low-dose and high-dose drug-coated balloon groups (16.7% vs. 12.1%, p = 0.62). Final angiography showed preserved distal flow (100% vs. 98.4%, p > 0.99). At 1 year, primary patency did not differ significantly between the low-dose drug-coated balloon and high-dose drug-coated balloon groups (88.0% vs. 85.7%, p = 0.72). Freedom from clinically driven target lesion revascularization (94.7% vs. 92.7%, p = 0.71) and amputation-free survival (90.0% vs. 87.8%, p = 0.79) did not differ between groups.
CONCLUSIONS: No statistically significant differences in angiographic or 1-year clinical outcomes were observed between low-dose and high-dose drug-coated balloons in propensity score-matched patients.