Efficacy and Safety of Dual Paclitaxel and Sirolimus Nanoparticle-Coated Balloon

IF 8.4 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC: Basic to Translational Science Pub Date : 2024-06-01 DOI:10.1016/j.jacbts.2024.02.002

Kenji Kawai MD , Mohammed Tanjimur Rahman PhD , Ryan Nowicki BS , Frank D. Kolodgie PhD , Atsushi Sakamoto MD , Rika Kawakami MD , Takao Konishi MD , Renu Virmani MD , Vinod Labhasetwar PhD , Aloke V. Finn MD

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Abstract

We evaluated a novel dual active pharmaceutical ingredient (API) drug-coated balloon (DCB), which consists of a coating of nanoparticles encapsulating low-dose paclitaxel (PTX) in combination with sirolimus in a synergistic ratio. Compared to the PTX DCB, the dual API DCB demonstrated similar inhibition of cell proliferation in vitro but at a significantly lower total drug dose (over 13 times lower than sirolimus nanoparticles). Animal experiments demonstrated that the dual API DCB is more effective in inhibiting intimal cell proliferation with insignificant downstream embolic effects and myocardial damage compared to the PTX DCB. These findings indicate that dual API DCBs have a high potential to demonstrate improved clinical outcomes and a greater safety profile than the PTX DCBs.

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紫杉醇和西罗莫司纳米粒子双涂层球囊的有效性和安全性

我们评估了一种新型双活性药物成分（API）药物涂层球囊（DCB），该球囊由包裹低剂量紫杉醇（PTX）的纳米颗粒与西罗莫司以协同比例组合而成。与 PTX DCB 相比，双 API DCB 在体外对细胞增殖的抑制作用相似，但药物总剂量明显更低（比西罗莫司纳米颗粒低 13 倍以上）。动物实验表明，与 PTX DCB 相比，双 API DCB 能更有效地抑制内膜细胞增殖，且下游栓塞效应和心肌损伤不明显。这些研究结果表明，与 PTX DCB 相比，双 API DCB 极有可能改善临床疗效并提高安全性。

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来源期刊

JACC: Basic to Translational Science CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

14.20

自引率

1.00%

发文量

161

审稿时长

16 weeks

期刊介绍： JACC: Basic to Translational Science is an open access journal that is part of the renowned Journal of the American College of Cardiology (JACC). It focuses on advancing the field of Translational Cardiovascular Medicine and aims to accelerate the translation of new scientific discoveries into therapies that improve outcomes for patients with or at risk for Cardiovascular Disease. The journal covers thematic areas such as pre-clinical research, clinical trials, personalized medicine, novel drugs, devices, and biologics, proteomics, genomics, and metabolomics, as well as early phase clinical trial methodology.

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