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. 2025 Mar 8:S1553-8389(25)00102-2.
doi: 10.1016/j.carrev.2025.03.009. Online ahead of print.

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

Masafumi Ono  1 , Taku Asano  2 , Masahiko Noguchi  3 , Norihiro Kogame  4 , Raisuke Iijima  5 , Kohei Osakada  6 , Kenji Ando  7 , Takayuki Ishihara  8 , Koji Nishida  9 , Mamoru Nanasato  10 , Kengo Tanabe  11 , Takashi Muramatsu  12 , Atsunori Okamura  13 , Yoshihisa Kinoshita  14 , Kiyoshi Hibi  15 , Satoru Suwa  16 , Nehiro Kuriyama  17 , Kozo Okada  18 , Gaku Nakazawa  19 , Takashi Ashikaga  20 , Yutaka Tadano  21 , Hiroki Shiomi  22 , Masato Nakamura  5 , Akiyoshi Miyazawa  23 , Satoshi Miyata  24 , Kiyoko Uno  25 , Kazushige Kadota  6 , Ken Kozuma  26 ; NATURE trial investigators
Affiliations
Free article

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

Masafumi Ono et al. Cardiovasc Revasc Med. .
Free article

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.

Clinical trial registration url: https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.

Keywords: Coronary artery disease; Cutting balloon; Design paper; Drug-coated balloon; Late lumen enlargement; PCI; Predilatation.

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Conflict of interest statement

Declaration of competing interest K Ando reports personal fees from Japan Lifeline, personal fees from Abbott Medical Japan, personal fees from Medtronic Japan, personal fees from BIOTRONIK Japan, personal fees from TERUMO, and personal fees from Novartis Pharma. M Nanasato received lecture fees from Abbott Medical Japan and Boston Scientific Japan. K Tanabe reports remuneration for lecture from Boston Scientific, Abbott Medical, Kaneka, OrbusNeich, and Terumo. T Muramatsu received honoraria from Boston Scientific Japan. A Okamura reports remuneration for lecture from Terumo. Y Kinoshita reports personal fees from Boston Scientific. K Hibi reports research funding from Boston Scientific. G Nakazawa reports personal fees from Abbott Medical, Boston Scientific Japan, Terumo, Shockwave Medical Japan, HeartFlow, Medtronic, and OrbusNeich. M Nakamura reports personal fees from Terumo, personal fees from Boston Scientific, and is an advisor of Terumo, Boston Scientific, and Shockwave Medical Japan. K Kozuma reports personal fees from Boston Scientific, personal fees from Abbott Medical, personal fees from Medtronic, research funding from Abbott Medical. All other co-authors have nothing to disclose.

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