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Over time, bleeding risk conferred by ticagrelor drops in prior MI
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Patients with a history of MI who were treated with low-dose ticagrelor had less risk for bleeding after 1 year, according to a study published in the Journal of the American College of Cardiology.
Although patients continued to have risk for recurrent long-term atherothrombotic events, antithrombotic benefit conferred by low-dose ticagrelor (Brilinta, AstraZeneca) remained consistent from 1 year to 3 years, according to the researchers.
PEGASUS-TIMI 54 trial data
Marc P. Bonaca, MD, MPH, investigator for the TIMI Study Group, associate physician in cardiovascular medicine at Brigham and Women’s Hospital and assistant professor of medicine at Harvard Medical School, and colleagues reviewed data from 21,162 patients from the PEGASUS-TIMI 54 trial who were randomly assigned 60 mg ticagrelor two times per day (n = 7,045), 90 mg ticagrelor two times per day (n = 7,050) or placebo (n = 7,067) in addition to low-dose aspirin.
Patients were aged at least 50 years, had a spontaneous MI 1 to 3 years before enrollment and at least one high-risk feature such as diabetes that required medication, aged at least 65 years or a second spontaneous MI before enrollment. Follow-up was conducted for a median of 2.7 years.
The primary efficacy endpoint was a composite of MI, CV death or stroke. TIMI major bleeding was the primary safety endpoint.
At the end of the trial, 28% of patients were at least 5 years from their index spontaneous MI. Patients assigned placebo had a constant risk for CV death, stroke or MI.
The benefit conferred by 60 mg ticagrelor for the primary outcome was consistent at the first (HR = 0.82; 95% CI, 0.67-0.99), second (HR = 0.9; 95% CI, 0.74-1.11) and third year (HR = 0.79; 0.62-1), Bonaca and colleagues wrote.
The risk for TIMI major bleeding in patients assigned 60 mg ticagrelor declined over time (HR for first year = 3.22; 95% CI, 1.86-5.57; HR for second year = 2.07; 95% CI, 1.25-3.43; HR for third year = 1.65; 95% CI, 0.84-3.24), according to the researchers.
Primary efficacy event reduction
Compared with patients assigned placebo, the rate of primary efficacy events was reduced by 17% for those assigned ticagrelor 60 mg (incidence rate ratio = 0.83; 95% CI, 0.72-0.95) and 17% for patients assigned ticagrelor 90 mg (incidence rate ratio = 0.83; 95% CI, 0.723-0.95).
“These data may support clinician decision making in evaluating the risk-benefit ratio of long-term ticagrelor in patients with prior MI,” Bonaca and colleagues wrote.
“We agree that prolonged therapy with ticagrelor should be considered in patients with a history of MI who tolerate the drug,” John A. Bittl, MD, a cardiologist at the Interventional Cardiology Group at Munroe Regional Medical Center in Ocala, Florida, and David J. Maron, MD, clinical professor of cardiovascular medicine at Stanford University School of Medicine, wrote in a related editorial. “Although all patients should ideally be treated with all effective preventive and therapeutic measures, this is sometimes unfeasible in practice. If a physician uses the same absolute measure of benefit and harm for different treatments, it is possible to see which interventions are likely to have the biggest payoff and should be given the strongest attention.” – by Darlene Dobkowski
Disclosures: The study was funded by AstraZeneca. Bonaca reports consulting for Aralez, AstraZeneca, Bayer and Merck and receiving grant support from AstraZeneca. Please see the study for all other authors’ relevant financial disclosures. Bittl and Maron report they have no relevant financial disclosures.
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