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A single-centre real-world study on the application of drug-coated balloons in coronary intervention therapy
Chen Shuangyu1, Li Min1, Xu Jun2
1Department of Cardiology, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Insights
Drug-coated balloon (DCB) therapy showed infrequent mortality and recurrent myocardial infarction in real-world coronary interventions. However, major adverse cardiovascular events (MACE), primarily target vessel revascularization, occurred in nearly one-fifth of patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Medicine
Background:
- Drug-coated balloons (DCB) are utilized in coronary intervention therapy.
- Real-world data on DCB effectiveness and safety is crucial for clinical practice.
- Understanding long-term outcomes of DCB treatment is essential.
Purpose of the Study:
- To investigate the real-world experience and outcomes of drug-coated balloon (DCB) use in coronary intervention.
- To analyze the effectiveness and safety profile of DCB therapy in a large patient cohort.
- To identify risk factors associated with major adverse cardiovascular events (MACE) after DCB treatment.
Main Methods:
- A single-center, retrospective study involving 1,118 patients undergoing DCB treatment.
- Data collection included clinical, biochemical, interventional, and follow-up parameters over 2-5 years.
- Statistical analysis, including multivariable Cox regression, was performed to assess outcomes and risk factors.
Main Results:
- The overall incidence of major adverse cardiovascular events (MACE) was 17.1%, predominantly driven by target vessel revascularization (14.9%).
- Mortality (1.9%) and recurrent myocardial infarction (1.3%) were infrequent.
- Independent risk factors for MACE included cutting balloon use and smoking, while larger culprit vessel diameter was protective.
Conclusions:
- DCB-based coronary intervention demonstrated infrequent mortality and recurrent MI in this real-world cohort.
- MACE, largely attributed to target vessel revascularization, occurred in a significant proportion of patients.
- Factors such as culprit vessel diameter, cutting balloon use, smoking, vascular calcification, bailout stenting, and vessel length influenced TVR risk.
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.
