Selection criteria in the era of perfect competition for drug-eluting stents - a survey of interventional cardiologists in Japan: the selection-DES study.

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI:10.1080/17434440.2023.2277221
Satoru Hashimoto, Yoshihiro Motozawa, Toshiki Mano
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Abstract

Background: More than 20 years have passed since the first company introduced drug-eluting stent (DES) in 2002, but competing companies still have improved their DESs under regulatory approval. This study aimed to investigate the criteria for interventional cardiologists performing percutaneous coronary intervention (PCI) in selecting a DES.

Research design and methods: From 10 April 2023, to 30 April 2023, 3,422 cardiologists were requested to complete a questionnaire, of whom 126 responded to the survey.

Results: Overall, 86.5% of the respondents used Xience cobalt-chromium everolimus-eluting stent (Xience) in > 10% of PCI procedures. For Xience, brand loyalty and calcified lesions were important independent variables for the DES selection criteria. Ultimaster sirolimus-eluting stent (Ultimaster) was not affected by the clinical data delivered by the company, whereas the respondents were shown to seek support for their activities from the Ultimaster supplier. The relationship with the company and/or sales representative and the planned surgical procedure affected the use of Coroflex ISAR NEO sirolimus-eluting polymer-free stent.

Conclusions: Patient background and lesion characteristics had little impact on the DES selection criteria, suggesting that DES performance has already reached its physical limitations to the extent that respondents may not value further improvements in performance or characteristics of DES.

药物洗脱支架完全竞争时代的选择标准——对日本介入心脏病专家的调查——选择DES研究。
背景:20多个 自2002年第一家公司推出药物洗脱支架(DES)以来,几年过去了,但竞争公司仍在监管部门的批准下改进了其DES。本研究旨在调查介入心脏病专家进行经皮冠状动脉介入治疗(PCI)选择DES的标准。研究设计和方法:从2023年4月10日到2023年四月30日,3422名心脏病专家被要求填写问卷,其中126人对调查做出了回应。结果:总体而言,86.5%的受访者在 > PCI手术的10%。对于Xience来说,品牌忠诚度和钙化病变是DES选择标准的重要自变量。Ultimaster西罗莫司洗脱sten(Ultimaster)不受该公司提供的临床数据的影响,而受访者则向Ultimaster供应商寻求对其活动的支持。与公司和/或销售代表的关系以及计划的手术程序影响了Coroflex ISAR NEO西罗莫司洗脱聚合物无支架的使用。结论:患者背景和病变特征对DES的选择标准几乎没有影响,这表明DES的性能已经达到了其物理极限,受访者可能不重视DES性能或特征的进一步改进。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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