Immediate and Short Term Outcomes for Using Drug Coated Balloons in Treating Coronary Bifurcation Lesions

Abstract

Abstract Background lesions at the bifurcation of coronary arteries pose a substantial difficulty due to their intricate anatomical structure and the increased risk of complications during or after the procedures. Drug-coated balloons (DCBs) have recently been recognized as a promising therapeutic strategy for managing bifurcation lesions. Objective to compare the use of drug-coated balloons versus ordinary balloons in provisional stenting of coronary artery bifurcation lesions and its impact on the procedural success rate & short-term MACE Patients and Methods The current study is a prospective, longitudinal cohort, interventional two arm study that included a total of 66 patients. 40 in Control group (group A) and 26 in case group (group B). every patient is assigned to a particular group based on the operator’s preference. In both groups provisional stenting was employed, with dilation of the side branch using a standard balloon in group “A” and a drug-coated balloon in group “B”. The evaluation of the outcomes of the indexed procedure and a six-month follow-up were conducted to monitor the incidence of Major Adverse Cardiac Events (MACE). Results The mean age of patients assigned to the Group A was 57.18 ± 9.84 years, while patients assigned to the Group B had a mean age of 55.50 ± 7.74years, both groups were similar in demographic data, baseline clinical characteristics and Echocardiographic Data. The study’s primary endpoint was the occurrence of major adverse cardiac events (MACEs), at a 6-month follow-up. A significant difference was observed between the case and control groups in terms of MACE after 6 months. The incidence of MACE was 23.7% (9 out of 38 patients who continued the study after 2 cases of in- hospital mortality) in the control group, compared to only 3.9% (1 out of 26 patients) in the case group, with a p-value of 0.039. the secondary endpoints of the study, which encompassed the attainment of lesion success and procedure success, did not show a statistically significant difference between the case and control groups despite the observed variation in the complication rat Conclusion The application of drug-coated balloons in provisional stenting for coronary artery bifurcation lesions demonstrated superiority over conventional balloons in terms of short-term major adverse cardiac events (MACE), and exhibited non-inferiority in relation to lesion or procedural success.