SCORE-CUT: A Randomized Trial Comparison of Scoring, Cutting, and Non-Compliant Balloon Lesion Preparation Strategies for Drug-Coated Balloon Angioplasty-Rationale and Design.

BACKGROUND: Drug-coated balloons (DCB) provide a "metal-free" alternative to drug-eluting stents, yet their success is highly dependent on optimal lesion preparation for effective drug transfer and to minimize acute recoil. While scoring balloons (SB) and cutting balloons (CB) are hypothesized to achieve superior plaque modification versus non-compliant balloons (NCBs) through controlled micro-dissections, high-quality randomized evidence in de-novo coronary lesions remains sparse. AIM: SCORE-CUT aims to determine the optimal lesion-preparation strategy prior to DCB angioplasty by directly comparing the efficacy of pre-dilation with NCB, SB, and CB. METHODS: This is a prospective, multi-center, randomized trial conducted across sites in Australia, New Zealand, and Singapore (ACTRN12625001349437). A total of 198 patients with de-novo lesions (2.0-4.0 mm diameter on angiography) are randomized 1:1:1 to undergo lesion preparation with NCB, SB, or CB. Intravascular ultrasound (IVUS) imaging is performed both before and after lesion preparation. The primary endpoint is absolute minimum lumen area (MLA) gain (mm2) on IVUS after lesion preparation, analyzed by an independent, blinded core laboratory. Secondary endpoints include percentage MLA gain, frequency of flow-limiting dissections, and rates of bailout stenting. The study is powered to detect a 0.8 mm2 difference in absolute MLA gain, with statistical significance at p < 0.05. Enrollment has commenced (n = 4) and the study is expected to complete enrollment by the end of 2026. CONCLUSIONS: SCORE-CUT is the first randomized trial to provide a head-to-head comparison of NCB, SB, and CB using IVUS-derived primary endpoints in de-novo disease. By utilizing intravascular imaging, the trial will provide robust evidence to standardize vessel preparation in DCB angioplasty.