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Randomized trials have shown comparable outcomes between second-generation low-dose drug-coated balloons (LD-DCBs) and first-generation high-dose drug-coated balloons (HD-DCBs); but the trial patients had low clinical complexity, and there were no comparisons in medically complex populations. The aim of this study was to compare outcomes between an LD-DCB (Ranger; 2.0 μg/mm2) and an HD-DCB (IN.PACT; 3.5 μg/mm2) in patients with symptomatic femoropopliteal artery disease. PROSPECT MONSTER (Prospective Comparison of Second-Generation Low-Dose Drug-Coated Balloon With High-Dose Drug-Coated Balloon) was a prospective, multicenter, nonrandomized trial that prospectively collected data from 581 patients who underwent endovascular therapy with the LD-DCB (n = 370) or the HD-DCB (n = 211) for symptomatic femoropopliteal artery disease (Rutherford classes 2-5). The primary outcome was the 1-year primary patency of the LD-DCB in comparison with that of the HD-DCB, as evaluated using propensity score matching. The incidence of impaired flow after drug-coated balloon application was also evaluated. Propensity score matching extracted 163 pairs (358 and 163 patients in the LD-DCB and HD-DCB groups, respectively), with no significant intergroup difference in baseline characteristics. The 1-year primary patency rates in the matched population were similar between the LD-DCB and HD-DCB groups (87.0% [95% CI: 82.5%-91.7%] vs 81.3% [95% CI: 74.8%-88.5%]; HR: 0.93; 95% CI: 0.55-1.59; P = 0.79), as was the incidence of impaired flow (13.6% vs 9.8%; OR: 1.46; 95% CI: 0.78-2.73; P = 0.24). No baseline characteristics had any significant interaction effects on the association of the LD-DCB vs the HD-DCB and 1-year restenosis risk. LD-DCBs demonstrate efficacy and safety comparable with HD-DCBs in patients with complex clinical backgrounds, suggesting that drug-coated balloon treatment using a lower dose may be possible. Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.


Tatsuya Nakama, Mitsuyoshi Takahara, Yo Iwata, Kenji Suzuki, Kazuki Tobita, Naoki Hayakawa, Kazunori Horie, Shinsuke Mori, Kotaro Obunai, Takao Ohki, PROSPECT MONSTER Study Investigators. Low-Dose vs High-Dose Drug-Coated Balloon for Symptomatic Femoropopliteal Artery Disease: The PROSPECT MONSTER Study Outcomes. JACC. Cardiovascular interventions. 2023 Nov 13;16(21):2655-2665

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PMID: 37804292

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