Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality. [Review]

MedStar author(s):
Citation: American Heart Journal. 222:112-120, 2020 04.PMID: 32028137Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Angioplasty, Balloon/mt [Methods] | *Coated Materials, Biocompatible | *Paclitaxel/pd [Pharmacology] | *Peripheral Arterial Disease/su [Surgery] | *Stents | Antineoplastic Agents, Phytogenic/pd [Pharmacology] | Congresses as Topic | Humans | Prosthesis Design | United States | United States Food and Drug AdministrationYear: 2020ISSN:
  • 0002-8703
Name of journal: American heart journalAbstract: Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease. Copyright (c) 2019 Elsevier Inc. All rights reserved.All authors: Dan K, Garcia-Garcia HM, Hideo-Kajita A, Khalid N, Kolm P, Shlofmitz E, Torguson R, Waksman R, Wermers JPOriginally published: American Heart Journal. 222:112-120, 2019 Dec 28.Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-02-26
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Journal Article MedStar Authors Catalog Article 32028137 Available 32028137

Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease. Copyright (c) 2019 Elsevier Inc. All rights reserved.

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