Effectiveness and Safety of Drug-coated Balloons in Treating De Novo Lesions in Large Coronary Vessels of Elderly Patients: a Cohort Study

Abstract

Background In recent years, with the aging of the population, the incidence of coronary artery large vessel disease in elderly patients has significantly increased. Drug-coated balloons (DCB), as an emerging treatment method, have attracted considerable attention due to their ability to effectively reduce the rate of restenosis. However, existing studies have largely focused on small vessel lesions, with limited data on the effectiveness in de novo large vessel lesions. Objective To explore the effectiveness of DCBs in treating de novo large coronary artery vessel lesions in elderly patients. Methods A retrospective selection of 128 elderly patients (>60 years) with coronary heart disease (CHD) who underwent percutaneous coronary intervention (PCI) at the Affiliated Hospital of Inner Mongolia Medical University in 2022 was conducted. Preoperative examinations and laboratory tests were completed. The patients were divided into DCB group (n=30), Drug-eluting stent (DES) group (n=64), and bioresorbable vascular scaffold (BVS) group (n=34) according to the PCI treatment plan. Coronary angiography (CAG) was performed preoperatively, immediately postoperatively, and during the 1-year follow-up to observe the reference vessel diameter (RVD), minimum lumen diameter (MLD), and further calculate the preoperative diameter stenosis (DS), immediate postoperative lumen gain (AG), residual diameter stenosis (RDS) at immediate postoperative and 1-year follow-up, and late lumen loss (LLL). During the follow-up period, patients were regularly followed up in outpatient clinics or by telephone, recording major adverse cardiovascular events (MACE) within the hospital and within one year after discharge. LASSO regression analysis was used to screen relevant variables, followed by multifactorial Logistic regression analysis to explore the influencing factors of MACE. The Kaplan-Meier method was used to draw the survival curve of patients with MACE, and the comparison of survival curves was made using the Log-rank test. Results There was no statistically significant difference in the baseline data of patients in the DCB, DES, and BVS groups (P>0.05). Immediately postoperatively, the MLD and AG in the BVS group were higher than those in the DCB and DES groups, and the RDS was lower than those in the DCB and DES groups (P<0.05). At 1-year postoperatively, the RDS in the DES group was lower than that in the DCB group (P<0.05). No MACE occurred in the hospital in all three groups. The median follow-up time was 478 (425, 538) days, with a total of 38 MACE. No myocardial infarction or cardiac death occurred during the follow-up period. Bleeding events: there were 0 cases in the DCB group, 3 cases in the DES group, and 3 cases in the BVS group, manifested as gum bleeding, assessed as mild bleeding. The Log-rank test showed no statistically significant difference in the survival rate of patients without MACE events among the three groups (P=0.580). LASSO regression analysis included low-density lipoprotein cholesterol (LDL-C) and history of interventional treatment in the analysis, and the results of multifactorial Logistic regression analysis showed that LDL-C (OR=12.204, 95%CI=3.403-43.768) and history of interventional treatment (OR=0.041, 95%CI=0.010-0.162) were influencing factors for the occurrence of MACE. Conclusion Compared with DES and BVS, there is no significant difference in the treatment of large vessel lesions in elderly CHD patients with DCB, and its effectiveness and safety are comparable to that of DES and BVS. DCB is a safe and effective method for treating large coronary artery vessel lesions in elderly patients, and increased LDL-C and a history of interventional treatment are influencing factors for the occurrence of MACE.

Keywords

• coronary disease|percutaneous coronary intervention|coronary balloon angioplasties|drug-coated balloon|aged|cohort studies