Paclitaxel Drug-coated Balloon Angioplasty for De Novo Coronary Lesions in an Expanded Real World Clinical Setting: The Multicenter ALLIANCE Registry

BackgroundDespite limited clinical evidence, the use of drug-coated balloons (DCB) in percutaneous coronary intervention for de novo coronary lesions is expanding and increasing. Furthermore, recent randomized trial demonstrated that imaging guided DCB improves angiographic outcomes. MethodsALLIANCE 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. ResultsBetween 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, 25% showed diffuse disease, 26% were bifurcations, and 38% were treated a greater than 3 mm DCB balloon. Intravascular imaging was used in 88.5% (1755/1984) 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%, pnon-inferiority<0.001), and cd-TLR 2.9%. Thrombotic events during the follow-up period were limited to one case ConclusionsPaclitaxel DCB has proven effective and safe in the current expanding daily clinical practice. Utilizing imaging modalities during DCB procedure may improve DCB treatment outcomes. What is Known?O_LIClinical applications of paclitaxel DCBs are being explored for a variety of lesion subsets and clinical presentations; however, their expanded clinical use has not been validated in large-scale prospective studies. C_LIO_LIGuidance from imaging devices may enhance the potential of DCBs in routine clinical practice; however, no data demonstrate clinical benefit from the combined use of DCBs and imaging modality. C_LI What the study adds?O_LIPaclitaxel DCB was effective and safe in various coronary artery lesion and clinical settings in real world practice. C_LIO_LIThe use of an imaging modality may enable optimal preparation of lesions, increasing the inherent potential of DCB in daily practice. C_LI