To Evaluate the ‘Real World’ Clinical Performance of Bisoprolol in Post-Myocardial Infarction with Left-Ventricular Dysfunction: TENACITY Study

Abstract

Objective: To Study the impact of Bisoprolol on Heart Rate (HR) and Left Ventricular Ejection Fraction (LVEF) along with metabolic indicators of HbA1C and lipid profile in post-ACS Asians patients at 1 year. Methods: Retrospective data of 400 patients was collected and assessed for the effectiveness of oral Bisoprolol (1.25, 2.5, 5 and 10 mg) over a 1-year, in post-ACS patients with LVSD. Change in LVEF and HR as primary endpoints, and change in Lipid profile, HbA1C and ST segment deviation of J point as secondary endpoints were evaluated. Results: Patients having mean age of 55.28±7.9 years (29.75% female), showed significant improvement in LVEF (41.45±5.1% vs 48.73±5.5%) with a reduction in HR (85.06±5.64 vs 76.73±4.6 bpm) at the end of 1-year treatment (p=0.0001) with Bisoprolol (mean 4.15+1.4 mg). NYHA class improved from mean 1.6+0.5 to 1.11+0.31. Bisoprolol along with GDMT was neutral for HbA1C (6.2±0.6 % vs 6.1±0.7%; p=0.64), while serum lipids (Total Cholesterol: 199.7+7.6 vs 127.6+4.85 mg, p=0.001; TG: 196.2 +12.1 vs 111.7+6.88 mg%, p=0.001; LDL: 126.9+9.1 vs 62.4+5.51 p=0.001; HDL: 33.7+3 vs 42.8+1.9 p=0.001) improved due to statins started at baseline. Maximum ST deviation at J point in resting ECG was also lesser at 1 year as compared to baseline (0.29+1.5 mm vs 0.05+0.22 mm; p=0.0001). Conclusion: Bisoprolol started along with GDMT to patients in acute phase of post-ACS with LVSD significantly improved LVEF, with significant reduction in HR and ST segment deviation at J point, without adverse effect on lipid and HbA1C.