One‐Year Clinical Outcomes of Paclitaxel‐Coated Balloon Angioplasty in Patients With and Without Acute Coronary Syndrome: The ALLIANCE Registry

Abstract

ABSTRACT Background Real‐world data after percutaneous coronary intervention (PCI) using drug‐coated balloons (DCBs) in acute coronary syndrome (ACS) are limited. Aims We compared 1‐year clinical outcomes after PCI with paclitaxel DCBs between the ACS and non‐ACS patients. Methods The ALLIANCE is a prospective, multicenter registry of PCI using paclitaxel DCBs. Primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization. Secondary endpoints included all‐cause mortality at 1 year. Adverse events were adjudicated by an independent committee. Propensity score matching was performed to adjust for baseline differences between the ACS and non‐ACS patients. Results From July 2023 to February 2024, 1794 patients with de novo lesions (ACS 513 [28.6%] and non‐ACS 1281 [71.4%]) were enrolled at 57 medical institutions in Japan. Mean age was 71 years, and 76% were male. Among ACS patients, 34.7% had ST‐segment elevation MI, 33.9% non–ST‐segment elevation MI, and 31.4% unstable angina. Intracoronary imaging was used in 88.5% of lesions. Bailout stenting after DCB angioplasty was required in only 1.1% of 1984 lesions. Technical success, defined as post‐procedural residual stenosis < 40% and absence of flow‐limiting coronary dissection, was significantly lower in patients with ACS than those with non‐ACS. At 1 year, TLF occurred in 7.0% of ACS and 3.8% of non‐ACS patients (adjusted HR 1.83; 95% CI 1.06–3.17, p = 0.03). All‐cause mortality was 6.4% and 3.3%, respectively (adjusted HR 2.06; 95% CI 1.13–3.75, p = 0.02). Conclusions One‐year TLF and all‐cause mortality were significantly higher in ACS than non‐ACS patients treated with paclitaxel DCBs in real‐world clinical settings. Registration: Japan Registry of Clinical Trials ( https://jrct.mhlw.go.jp ); unique identifier: jRCT1032230218.