Differences in clinical outcomes between pre- and post-marketing clinical study following paclitaxel-coated balloon catheter treatment for coronary in-stent restenosis: from the Japanese regulatory viewpoint

Mitsutake, Yoshiaki; Konishi, Akihide; Shiba, Takeshi; Ito, Tetsuhide; Ho, Mami; Shirato, Haruki

doi:10.1007/s00380-020-01676-z

Cited by 1 publication

(1 citation statement)

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“…The BMS-ISR is generally characterized by excessive neointimal proliferation (i.e., hyperplasia), whereas the DES-ISR is more complicated because it can be perceived as a result of antiproliferative drugs' insufficient effect or failure to function (i.e., late neoatherosclerosis). Indeed the DES-ISR was only independent predictor of target lesion revascularization (TLR) in Japanese pre-and post-marketing study for the SeQuent Please® DCB [26]. Intracoronary imaging techniques, preferably OCT, would be recommended to identify the underlying causes of ISR (class IIa, level of evidence C) [24].…”

Section: In-stent Restenosis (Isr)mentioning

confidence: 99%

Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics

Muramatsu

Kozuma

Tanabe

et al. 2023

Cardiovasc Interv and Ther

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Drug-coated balloon (DCB) technology was developed to deliver the antiproliferative drugs to the vessel wall without leaving any permanent prosthesis or durable polymers. The absence of foreign material can reduce the risk of very late stent failure, improve the ability to perform bypass-graft surgery, and reduce the need for long-term dual antiplatelet therapy, potentially reducing associated bleeding complications. The DCB technology, like the bioresorbable scaffolds, is expected to be a therapeutic approach that facilitates the “leave nothing behind” strategy. Although newer generation drug-eluting stents are the most common therapeutic strategy in modern percutaneous coronary interventions, the use of DCB is steadily increasing in Japan. Currently, the DCB is only indicated for treatment of in-stent restenosis or small vessel lesions (< 3.0 mm), but potential expansion for larger vessels (≥ 3.0 mm) may hasten its use in a wider range of lesions or patients with obstructive coronary artery disease. The task force of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) was convened to describe the expert consensus on DCBs. This document aims to summarize its concept, current clinical evidence, possible indications, technical considerations, and future perspectives.

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Section: In-stent Restenosis (Isr)mentioning

confidence: 99%