Cutting balloon versus standard balloon for lesion preparation of drug-coated balloon treatment in de-novo coronary artery lesions: Rationale and Design of the Randomized NATURE trial.
{"title":"Cutting balloon versus standard balloon for lesion preparation of drug-coated balloon treatment in de-novo coronary artery lesions: Rationale and Design of the Randomized NATURE trial.","authors":"Masafumi Ono, Taku Asano, Masahiko Noguchi, Norihiro Kogame, Raisuke Iijima, Kohei Osakada, Kenji Ando, Takayuki Ishihara, Koji Nishida, Mamoru Nanasato, Kengo Tanabe, Takashi Muramatsu, Atsunori Okamura, Yoshihisa Kinoshita, Kiyoshi Hibi, Satoru Suwa, Nehiro Kuriyama, Kozo Okada, Gaku Nakazawa, Takashi Ashikaga, Yutaka Tadano, Hiroki Shiomi, Masato Nakamura, Akiyoshi Miyazawa, Satoshi Miyata, Kiyoko Uno, Kazushige Kadota, Ken Kozuma","doi":"10.1016/j.carrev.2025.03.009","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) in de novo coronary artery diseases (CADs). However, the optimal predilatation strategy prior to DCB dilatation has yet to be validated.</p><p><strong>Methods/design: </strong>The NATURE (Non-stent PCI with an appropriate dilatation by means of cutting balloon and drug-coated balloon in de novo lesion) study is a prospective, multi-center, randomized controlled trial designed to evaluate the safety and efficacy of a cutting balloon compared to standard balloons (semi-compliant or non-compliant balloons) for lesion preparation prior to DCB treatment in normal-sized vessels. The DCB treatment is performed with the guidance of intravascular ultrasound (IVUS) and fractional flow reserve (FFR). The study will enroll 200 patients with a single de novo coronary lesion (reference vessel diameter: 2.5-4.0 mm) at 18 sites. Patients are randomized 1:1 to undergo predilatation with either a cutting or standard balloons, followed by DCB dilatation. The primary endpoint is the success rate of optimal predilatation, as defined by the International DCB Consensus Group: no flow-limiting dissections, residual stenosis ≤30 %, and FFR >0.80. Secondary endpoints include in-segment late lumen loss (LLL) at 9 months, the incidence of bailout stenting, and clinical outcomes at 6 and 12 months.</p><p><strong>Summary: </strong>The NATURE study aims to address the critical gap in evidence regarding optimal predilatation for DCBs in de novo CADs. By utilizing state-of-the-art DCB treatment strategies, including cutting balloons, intravascular imaging, and physiological tools, this study is expected to provide meaningful insights for refining DCB-based PCI strategies.</p><p><strong>Clinical trial registration url: </strong>https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6000,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiovascular Revascularization Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.carrev.2025.03.009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) in de novo coronary artery diseases (CADs). However, the optimal predilatation strategy prior to DCB dilatation has yet to be validated.
Methods/design: The NATURE (Non-stent PCI with an appropriate dilatation by means of cutting balloon and drug-coated balloon in de novo lesion) study is a prospective, multi-center, randomized controlled trial designed to evaluate the safety and efficacy of a cutting balloon compared to standard balloons (semi-compliant or non-compliant balloons) for lesion preparation prior to DCB treatment in normal-sized vessels. The DCB treatment is performed with the guidance of intravascular ultrasound (IVUS) and fractional flow reserve (FFR). The study will enroll 200 patients with a single de novo coronary lesion (reference vessel diameter: 2.5-4.0 mm) at 18 sites. Patients are randomized 1:1 to undergo predilatation with either a cutting or standard balloons, followed by DCB dilatation. The primary endpoint is the success rate of optimal predilatation, as defined by the International DCB Consensus Group: no flow-limiting dissections, residual stenosis ≤30 %, and FFR >0.80. Secondary endpoints include in-segment late lumen loss (LLL) at 9 months, the incidence of bailout stenting, and clinical outcomes at 6 and 12 months.
Summary: The NATURE study aims to address the critical gap in evidence regarding optimal predilatation for DCBs in de novo CADs. By utilizing state-of-the-art DCB treatment strategies, including cutting balloons, intravascular imaging, and physiological tools, this study is expected to provide meaningful insights for refining DCB-based PCI strategies.
期刊介绍：
Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
