Paclitaxel drug-coated balloon angioplasty for de novo coronary lesions in an expanded real world clinical setting: the multicenter ALLIANCE registry

Despite limited clinical evidence, the use of drug-coated balloons (DCB) in percutaneous coronary intervention for de novo coronary lesions is expanding and increasing. ALLIANCE is a prospective, multicenter, all-comer registry designed to evaluate the efficacy and safety of the paclitaxel-DCB in an expanded real-world clinical setting. A calculated sample size of 1500 patients was expected to provide 95% power to detect non-inferiority against a performance goal of 7.5% target lesion failure (TLF) at 1 year with a 3.0% absolute non-inferiority margin. Cases in which DCB was performed after successful lesion preparation were consecutively enrolled. The Primary endpoint was TLF, a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization (cd-TLR) at 1 year. An independent clinical events committee adjudicated all primary endpoint events. Between July 2023 and February 2024, 1794 patients (with 1984 lesions) were enrolled at 57 sites in Japan. Mean age was 71 years, 76% of patients were male, 45% had diabetes mellitus, and 29% presented with acute coronary syndromes. Among lesion characteristics, 31% were calcified lesions, and 34% were treated a greater than 3 mm DCB balloon. Intravascular imaging was used in 88.5% of lesions. Lesion preparation was performed with modified balloons in 68% of cases and by atherectomy in 19%. Bail-out stenting after DCB was required in 1.1% of patients. The rate of TLF at 1 year was 4.7% overall (95%CI 3.8–5.8%, p_{non-inferiority} < 0.001), and cd-TLR 2.9%. Paclitaxel DCB demonstrated favorable safety and efficacy profiles in the current expanding clinical practice. Japan Registry of Clinical Trials (jRCT1032230218). https://jrct.mhlw.go.jp.