Cross-Sectional Analyses to Assess the Clinical Safety and Effectiveness of Bisoprolol in Patients With Non-obstructive Coronary Artery Disease Who Underwent Percutaneous Coronary Intervention: A Post-hoc Analysis

Introduction: Elevated central aortic pressure, cardiac output and peripheral vascular resistance contribute to high morbidity in relation to end organ dysfunction in obstructive and non-obstructive coronary artery disease (NOCAD) cases despite revascularization. Bisoprolol preempts further progression of left ventricular dysfunction in such cases due to anti-ischemic and anti-hypertensive effects, further extending its evaluation in local Indian settings.

Methods: Post-hoc analyses of NOCAD patients with epicardial stenosis (N=378, 30 to 70% stenosis) from cross-sectional analyses conducted across eighty centers in India. Local ethics approval for study documents and endpoints for analyses was conducted in adherence to ICH-Good Clinical Practice (GCP) and Declaration of Helsinki guidelines. Descriptive and analytical statistics were performed using SPSS Version 29.0.1.0 (IBM Corp., Armonk, NY, USA).

Results: Per-protocol analyses of NOCAD (N=378) showed (mean) age: 58.63 years (286 males and 92 females); mean weight: 75.49kg; mean BMI: 27.78kg/m² and baseline left ventricular ejection fraction (LVEF): (46.85%). Prevalent risk factors include hypertension (100%), dyslipidemia (51.85%), smoking (24.07%), type 2 diabetes (59.52%), stroke (20.37%) and peripheral artery disease (4.76%). In overall population (n=800), bisoprolol (2.5 to 5mg/day) showed significant reduction in resting heart rate (RHR) (14bpm), and LVEF (5.08%). Similarly, in NOCAD cases significant changes in RHR (12.14bpm), and LVEF (4.68%) were noted at 24 weeks. Adverse events included chest congestion (6.61%), asthenia (5.03%), hypotension (4.76%), muscular weakness (3.70%), and bradycardia (1.85%) that were mild to moderate with none requiring treatment withdrawal.

Conclusion: Bisoprolol remains a clinically feasible option in Indian patients with NOCAD cases following percutaneous coronary intervention (PCI) as it reduces RHR and improves LVEF. Despite high rates of cardiovascular risk factors like age, type 2 diabetes and diffuse polyvascular disease, the drug was well-tolerated, with fewer adverse events. These results support the use of bisoprolol in managing NOCAD in Indian patients, highlighting its potential therapeutic uses to prevent further cardiac dysfunction.