Abstract 15061: Long-Term Outcome of Stentless Coronary Intervention With Drug-Coated Balloon in Patients With High Bleeding Risk

Introduction: Conventional PCI with stenting in high bleeding risk (HBR) patients is associated withhigher all-cause mortality rates and bleeding complications. To minimize DAPT duration, stentlessPCI using drug-coated balloons (DCB) is increasingly favored. However, there is a lack ofcomprehensive long-term outcome data on stentless therapy in HBR patients within real-worldclinical practice.

Research Questions: Do discernible disparities exist in the extended-term ramifications of stentless treatment utilizing DCB between patients classified as having HBR and those without in clinical practice?

Methods: We incorporated patients who underwent stentless PCI employing DCB for de novo lesions at our medical facility from January 2015 to December 2021. Exclusion criteria encompassedpatients presenting with acute coronary syndromes. The primary outcome measure was defined as all-cause mortality, whereas the secondary outcome measure focused on bleeding events as per thedefined criteria of BARC bleeding grades 3 or 5. Patients were stratified into two cohorts based on the ARC-HBR criteria and subsequently subjected to comparative analysis utilizing Cox proportional hazards regression analysis.

Results: A total of 392 patients were included, including a mean age of 70 ± 11 years and 46% male. Of these patients, 62% had HBR, and the procedure's success rate was 99.7%. Over a median follow-up period of 24 months, 29 patients (7.4%) experienced all-cause mortality. HBR patients showed significantly higher blood BNP levels compared to non-HBR patients (median [IQR]: 85pg/mL [36-226] vs. 27 pg/mL [15-49], p<0.01). After adjusting for blood BNP levels, the hazard ratio for all-cause mortality in HBR patients was 4.06 [1.18-14.00], indicating a 4-fold higher risk compared to non-HBR patients (p=0.03). Among the cohort, 12 individuals (1.8%) experienced BARC grades 3 or 5 bleeding events, with a tendency towards a greater occurrence in the HBRpatient group (adjusted HR: 2.26 [0.46-11.20], p=0.32), although the difference was not significant.

Conclusions: The findings further indicate that patients with HBR exhibit a propensity for inferior long-term outcomes relative to non-HBR patients in stentless treatment with DCB in the real world.