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Published on: September 20, 2019
Clinical safety profile of ticagrelor compared to clopidogrel in 1208 patients: Real world evidence
Viveka Kumar1, Vivek Kumar1, Kajal Kumari2
1Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.
Insights
Ticagrelor and clopidogrel show similar safety profiles for patients undergoing PCI, with no significant differences in major bleeding events. However, ticagrelor was associated with a higher rate of minor bleeding in real-world Indian patient data.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Dual antiplatelet therapy is standard post-PCI.
- The PLATO trial favored ticagrelor over clopidogrel for ACS patients.
- Limited real-world data exists for Indian populations.
Purpose of the Study:
- To compare the safety of ticagrelor versus clopidogrel.
- To evaluate real-world outcomes in Indian patients undergoing PCI.
- To assess bleeding rates and other safety endpoints.
Main Methods:
- Retrospective observational study of 1208 patients undergoing PCI.
- Patients treated with either ticagrelor or clopidogrel.
- Analysis of in-hospital outcomes and bleeding events.
Main Results:
- No significant difference in major or life-threatening bleeding between ticagrelor and clopidogrel groups.
- Ticagrelor group showed a statistically significant increase in minor bleeding events (21.4% vs. 13.6%).
- Overall safety profile was comparable, aligning with PLATO trial findings.
Conclusions:
- Ticagrelor demonstrates a similar safety profile to clopidogrel in real-world PCI patients in India.
- Increased minor bleeding rates with ticagrelor warrant consideration.
- Findings support existing clinical trial data in a different population.
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.
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