TY - JOUR
T1 - Cutting balloon versus standard balloon for lesion preparation of drug-coated balloon treatment in de-novo coronary artery lesions
T2 - Rationale and design of the randomized NATURE trial
AU - Ono, Masafumi
AU - Asano, Taku
AU - Noguchi, Masahiko
AU - Kogame, Norihiro
AU - Iijima, Raisuke
AU - Osakada, Kohei
AU - Ando, Kenji
AU - Ishihara, Takayuki
AU - Nishida, Koji
AU - Nanasato, Mamoru
AU - Tanabe, Kengo
AU - Muramatsu, Takashi
AU - Okamura, Atsunori
AU - Kinoshita, Yoshihisa
AU - Hibi, Kiyoshi
AU - Suwa, Satoru
AU - Kuriyama, Nehiro
AU - Okada, Kozo
AU - Nakazawa, Gaku
AU - Ashikaga, Takashi
AU - Tadano, Yutaka
AU - Shiomi, Hiroki
AU - Nakamura, Masato
AU - Miyazawa, Akiyoshi
AU - Miyata, Satoshi
AU - Uno, Kiyoko
AU - Kadota, Kazushige
AU - Kozuma, Ken
N1 - Publisher Copyright:
© 2025 The Authors.
PY - 2025/12
Y1 - 2025/12
N2 - 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 ( N on-stent PCI with an a ppropriate dila t ation by means of c u tting balloon and d r ug-coated balloon in de novo l e sion) 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.
AB - 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 ( N on-stent PCI with an a ppropriate dila t ation by means of c u tting balloon and d r ug-coated balloon in de novo l e sion) 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.
KW - Coronary artery disease
KW - Cutting balloon
KW - Design paper
KW - Drug-coated balloon
KW - Late lumen enlargement
KW - PCI
KW - Predilatation
UR - https://www.scopus.com/pages/publications/105000101217
UR - https://www.scopus.com/pages/publications/105000101217#tab=citedBy
U2 - 10.1016/j.carrev.2025.03.009
DO - 10.1016/j.carrev.2025.03.009
M3 - Article
C2 - 40102168
AN - SCOPUS:105000101217
SN - 1553-8389
VL - 81
SP - 48
EP - 56
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
ER -