Study Overview
Objective: To assess whether ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing elective percutaneous coronary intervention (PCI).
Design: Multicenter, open-label, and prospective randomized control trial. Setting and participants: A total of 1910 patients with indication for PCI and at least 1 high risk characteristic were randomized to either ticagrelor or clopidogrel.
Main outcome measures: The primary outcome was the composite of PCI-related type 4a or 4b myocardial infarction or major myocardial injury. The primary safety outcome was major bleeding, evaluated within 48 hours of PCI.
Main results: At 48 hours, the primary outcome was observed in 334 of 941 patients (35%) in the ticagrelor group and 341 of 942 patients (36%) in the clopidogrel group (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.80-1.17; P = .75). The primary safety outcome did not differ between groups. Minor bleeding events at 30 days were more frequently observed with ticagrelor (11%) than clopidogrel (8%) (1.54; 95% CI 1.12-2.11; P = .007).
Conclusion: Among patients undergoing elective PCI, ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis. Ticagrelor did not cause increase in major bleeding compared to clopidogrel but did increase the rate of minor bleeding at 30 days.
Commentary
Standard treatment after PCI includes dual antiplatelet therapy combining adenosine diphosphate (ADP) receptor antagonist and aspirin. The newer generation thienopyridine prasugrel and the reversible direct acting oral antagonist of the ADP receptor ticagrelor, provides consistent and greater antiplatelet effect compared to clopidogrel, and are superior in reducing ischemic events when compared to clopidogrel in patients presenting with acute coronary syndrome (ACS).1,2 Therefore, current guidelines recommend ticagrelor and prasugrel in preference to clopidogrel in patients presenting with ACS.3,4 However, whether these findings of improved outcomes with newer agents compared to clopidogrel extends to patients with stable ischemic heart disease presenting for elective PCI is unknown.
In this context, Silvain et al investigated this clinical question and compared ticagrelor and clopidogrel by performing a well-designed multicenter randomized control trial in patients presenting with elective PCI. At 48 hours and at 30 days the composite of PCI-related type 4 myocardial infarction or major myocardial injury defined by the third universal definition5 was similar between the ticagrelor and clopidogrel groups. Although the incidence of major bleeding was not significantly different between the 2 groups, minor bleeding at 30 days was higher in the ticagrelor group (11%) than clopidogrel (8%) (1.54; 95% CI, 1.12-2.11, P = .007).