Clinical safety profile of ticagrelor compared to clopidogrel in 1208 patients: Real world evidence

Abstract

Introduction: Dual antiplatelet treatment is recommended by current clinical practice guidelines for patients undergoing PCI. The PLATO trial showed superiority of ticagrelor to clopidogrel in reducing the rate of death from vascular causes, myocardial infarction and stroke without increase in the rate of overall major bleeding in ACS patients. However, real world evidence in Indian patients is limited. The objective of this study is to compare safety profile of ticagrelor with clopidogrel in real world settings. Methodology: In this single centered retrospective observational study, a total of 1208 serial patient records undergoing PCI (ACS and stable angina patients as well) treated with Ticagrelor or Clopidogrel were collected and analyzed to look into in hospital outcomes. We excluded the patient’s data that were incomplete. Results: In total of 1208 patients, 604 patients received ticagrelor and similarly 604 patient received clopidogrel. No significant differences in the rates of major life threatening bleeding and any major bleeding were observed between ticagrelor and clopidogrel group (0.2% (n = 1) vs. 0.7% (n = 4), p = 0.18 and 2.8% (n = 17) vs. 3% (n = 18), p = 0.86 respectively). There was increase in minor bleeding rate with ticagrelor compared to clopidogrel (21.4% & 13.6%, p = 0.00). Conclusion: In the real world settings, patients undergoing PCI treated with ticagrelor showed similar safety profile compared to clopidogrel but with increase in minor bleeding rate. The observed results were in alignment with PLATO clinical trial. Keywords: Antiplatelet, P2Y12 inhibitors, Percutaneous coronary intervention