Ticagrelor reduces ischemic risk in patients with a history of acute myocardial infarction, but it increases the risk of bleeding. Keeping a delicate balance is paramount when prescribing long-term ticagrelor to patients with a history of infarction.
The PEGASUS-TIMI 54 study randomized 21,162 patients with a history of infarction on a 1:1:1 ratio: some received ticagrelor 60 mg twice a day, others ticagrelor 90 mg twice a day, and others received a placebo. All participants also took aspirin with their daily intake. The 60-mg dose of ticagrelor was already approved to be used chronically.
The final endpoints were TIMI major and minor bleeding. The causes of bleeding were categorized by site and etiology, and independent predictors were identified.
After a 3-year follow-up, ticagrelor 60 mg increased the risk of major and minor bleeding by 2% compared with placebo (1.4 % placebo versus 3.4 % ticagrelor).
This difference in bleeding was driven primarily by spontaneous gastrointestinal bleeds. A history of spontaneous bleeding requiring hospitalization and the presence of anemia were independent predictors of bleeding, but not of ischemic risk.
Read also: Ticagrelor: Yet Another Pleiotropic Effect?
Patients with at least 1 risk predictor had 3-fold higher rates of bleeding with ticagrelor 60 mg compared with subjects who had none (absolute risk increase, 4.4% versus 1.5%; p = 0.01).
Patients with neither predictor had a more favorable benefit profile with ticagrelor 60 mg twice a day plus low-dose aspirin compared with placebo combined with aspirin. Their benefit profile included a lower mortality rate (hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.65 to 0.96; p = 0.03).
Conclusion
In patients with prior myocardial infarction, bleeding is mainly caused by gastrointestinal reasons.
A history of spontaneous bleeding requiring hospitalization or the presence of anemia identified patients at a higher risk of bleeding. Patients with neither of these factors benefited from ticagrelor, even in terms of mortality.
Original Title: Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction.
Reference: Giulia Magnani et al. J Am Heart Assoc. 2021;10:e017008. DOI: 10.1161/JAHA.120.017008.
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