Abstract

AN OBSERVATIONAL COHORT STUDY ON CLINICAL SAFETY AND EFFICACY OF TICAGRELOR WITH LOW DOSE ASPIRIN FOR THE PREVENTION OF MAJOR ADVERSE CARDIOVASCULAR EVENTS

B. Manjula, Himangini Mandal, Kakkireni Sai Manasa, Yelkur Meghana*, Tahmina Begum and J. Rajendra Kumar

ABSTRACT

Background: ACS is a type of ischemic heart disease marked by myocardial ischemic states responsible for 1.8 million fatalities worldwide each year. The primary treatment for ACS with dual anti platelet therapy (DAPT) i.e., with ticagrelor (180mg, OD / 90 mg BID) & low dose aspirin (75-81 mg OD to maximum dose of 325mg), despite its popularity has contrasting clinical outcomes with respect to its safety & efficacy. This research aims to appraise the clinical safety & effectiveness of Ticagrelor in conjunction with low-dose aspirin in preventing MACE (efficacy) and lowering clinically significant adverse reactions (ADRs) (safety). Methods: 90 patients with ACS who were taking DAPT with Ticagrelor and low dosage aspirin and met the inclusion and exclusion criteria participated in this observational cohort trial, which was carried out in a single tertiary care Centre for 6 months. Rate of MACE's & TIMI score served as the primary objective for efficacy. The HAS BLED score, GRACE score, and ADRs that the patients reported were the main safety endpoints. Results: Among the 90 subjects registered for the study, there were 76 men (84.44%) and 14 women (15.55%) present. The majority of subjects were between the ages of 51 and 61, accounting for 34.44% among the age distribution ranging from 31 to 90 years. Of the 90 patients, 14(15.55%) have unstable angina, 35(38.88%) have STEMI, and 41(45.55%) have NSTEMI. Based on the LV function 9(10%) had severe LV dysfunction whereas 10(11.11%), 21(23.33%) had moderate & mild LV dysfunction respectively. HAS BLED assessment produced following outcomes-Chapter-6 Results: High risk of bleeding was seen in about 59(65.555%) and moderate risk of bleeding was observed in 31 (34.44%). The TIMI scores resulted in 5(5.55%) high risk, 50(55.55%) showed moderate risk & 35(38.88%) showed low risk. The grace score showed 10 (11.111%) high risk groups & 23(25.555%) moderate risk. Patients reported experiencing mild ADRS like Dyspnea (8.89%), dry cough, Headache (7.78%), Dizziness (10%), inadequate sleep (7.78%), Nose bleeding (4.44%). In our investigation, 2 cardiovascular events (Major Adverse Cardiovascular Events)-related deaths were recorded during therapy. Conclusion: In patients with ACS, Ticagrelor with low dose aspirin has significant safety & effectiveness profile, decreasing MACE’s without increasing risk of serious bleeding. Nonetheless, reports of minor bleeding incidents, additional ADRs (including dyspnea) & 2 MACE related deaths were noted.

Keywords: Acute Coronary Syndrome, aspirin, ticagrelor, HAS BLED score, TIMI score, Grace score.