Ono Masafumi, Asano Taku, Noguchi Masahiko, Kogame Norihiro, Iijima Raisuke, Osakada Kohei, Ando Kenji, Ishihara Takayuki, Nishida Koji, Nanasato Mamoru, Tanabe Kengo, Muramatsu Takashi, Okamura Atsunori, Kinoshita Yoshihisa, Hibi Kiyoshi, Suwa Satoru, Kuriyama Nehiro, Okada Kozo, Nakazawa Gaku, Ashikaga Takashi, Tadano Yutaka, Shiomi Hiroki, Nakamura Masato, Miyazawa Akiyoshi, Miyata Satoshi, Uno Kiyoko, Kadota Kazushige, Kozuma Ken
Department of Cardiology, St. Luke's International Hospital, Tokyo, Japan.
Department of Cardiology, St. Luke's International Hospital, Tokyo, Japan.
Cardiovasc Revasc Med. 2025 Mar 8. doi: 10.1016/j.carrev.2025.03.009.
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.
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.
https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.
药物涂层球囊（DCB）已成为初发冠状动脉疾病（CAD）经皮冠状动脉介入治疗（PCI）中药物洗脱支架（DES）的替代方案。然而，DCB扩张前的最佳预扩张策略尚未得到验证。
方法/设计：NATURE（初发病变中使用切割球囊和药物涂层球囊进行适当扩张的非支架PCI）研究是一项前瞻性、多中心、随机对照试验，旨在评估在正常尺寸血管中，与标准球囊（半顺应性或非顺应性球囊）相比，切割球囊在DCB治疗前进行病变预处理的安全性和有效性。DCB治疗在血管内超声（IVUS）和血流储备分数（FFR）的引导下进行。该研究将在18个地点招募200例患有单个初发冠状动脉病变（参考血管直径：2.5 - 4.0毫米）的患者。患者按1:1随机分组，接受切割球囊或标准球囊预扩张，随后进行DCB扩张。主要终点是国际DCB共识小组定义的最佳预扩张成功率：无血流限制性夹层、残余狭窄≤30%且FFR>0.80。次要终点包括9个月时节段内晚期管腔丢失（LLL）、补救性支架置入的发生率以及6个月和12个月时的临床结局。
NATURE研究旨在解决初发CAD中DCB最佳预扩张证据方面的关键空白。通过采用包括切割球囊、血管内成像和生理工具等先进的DCB治疗策略，本研究有望为完善基于DCB的PCI策略提供有意义的见解。
