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

Abstract

Beta-blockers are the cornerstone in management of heart failure and are well studied in Acute Coronary Syndromes (ACS). There is paucity of data of Bisoprolol in acute ICU setting in patients admitted with left ventricular systolic dysfunction (LVSD) with recent ACS, especially amongst Asian Indians. We evaluated 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 patients with LVSD at 1 year as compared to baseline.This non-interventional, retrospective, single center, secondary data collection study captured demographics, comorbidities, hemodynamics, concomitant medications and assessed the effectiveness of oral Bisoprolol (1.25, 2.5 mg, 5 mg and 10mg) treatment over a 1-year follow up period, in post-ACS patients with LVSD (i.e., HFmrEF and HFrEF; LVEF <50%). Data-records of 400 patients hospitalized between August 1, 2016 to November 30, 2018 were evaluated for change in LVEF as primary endpoint and change in HR and Lipid profile, HBA1C and ST segment deviation of J point at 1 year as compared to baseline as secondary outcomes.The mean age of 400 patients was 55.28±7.9 years of which 29.75% were female. Significant improvement in LVEF (41.45±5.1% vs 48.73±5.5%) with significant reduction in heart rate (85.06±5.64 bpm vs 76.73±4.6 bpm) was observed at the end of 1-year treatment as compared to baseline (p=0.0001 and p=0.0001 respectively) on treatment with Bisoprolol (mean 4.15 + 1.4 mg). NYHA class improved from 1.6 + 0.5 to 1.11 + 0.31 at the end of 1 year. 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 at 1 year due to statins. 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).Bisoprolol administered along with GDMT to patients post-ACS with LVSD significantly improved LVEF with significant reduction in heart rate and ST segment deviation at J point at 1 year without adverse effect on lipid and HBA1C.