A single-centre real-world study on the application of drug-coated balloons in coronary intervention therapy.

BACKGROUND

This study aimed to investigate the real-world experience of drug-coated balloon (DCB) in coronary intervention therapy.

METHODS

This study was a single-center, retrospective study included 1,118 patients who underwent DCB treatment at Shanghai Putuo Central Hospital from January 2019 to December 2023, with a follow-up period ranging from 2 to 5 years. Clinical data, biochemical test results, interventional parameters, and clinical follow-up data of patients were collected, the effectiveness and safety of DCB in a real-world setting were analysed.

RESULTS

Among the 1,118 patients who underwent drug-coated balloon (DCB) treatment, the incidence of major adverse cardiovascular events (MACE) was 17.1% (191 cases), including 21 deaths (1.9%), 14 recurrent myocardial infarctions (1.3%), and 167 target vessel revascularizations (14.9%). Procedural coronary artery dissection occurred in 144 patients (12.9%). Multivariable Cox regression analysis identified cutting balloon use (HR = 2.07; 95% CI: 1.31-3.28; P = 0.002) and smoking (HR = 7.65; 95% CI: 5.51-10.62; P < 0.001) as independent risk factors for MACE. Conversely, larger culprit vessel diameter (HR = 0.22; 95% CI: 0.14-0.35; P < 0.001) was independently associated with a reduced risk of MACE after DCB treatment.

CONCLUSION

In this real-world cohort of patients undergoing DCB-based coronary intervention, mortality and recurrent MI were infrequent, whereas MACE occurred in nearly one-fifth of the cohort, predominantly driven by TVR. Target vessel revascularization was associated with culprit vessel diameter, cutting balloon use, smoking status, vascular calcification, bailout stenting, and culprit vessel length.