Benefits of ticagrelor, aspirin for stroke outweigh risks over 30 days

The benefits of ticagrelor and aspirin outweighed the risk for major hemorrhage in patients with mild to moderate ischemic stroke or at high risk for transient ischemic attack during 30 days of treatment, according to a Neurology study.

“Due to their pharmacological effects, long-term treatment with P2Y₁₂ inhibitors is associated with an increased risk of bleeding, which has triggered interest in defining the duration of therapy with the best benefit-risk profile,” Yongjun Wang, MD, of Beijing Tiantan Hospital and Capital Medical University, and colleagues wrote.

Researchers sought to determine the short-term benefits and risks of ticagrelor with aspirin in patients with acute mild to moderate ischemic stroke or high-risk TIA in the THALES (The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and ASA for Prevention of Stroke and Death) trial.

They analyzed 11,016 patients (5,523 in the ticagrelor-aspirin group, 5,493 in the aspirin-only group; mean age, 65 years; 39% women) and evaluated the cumulative incidence of irreversible efficacy and safety outcomes at various intervals during the 30-day treatment period. Researchers categorized efficacy as major ischemic events, defined as a composite of ischemic stroke or non-hemorrhagic death, and safety as major hemorrhage, defined as a composite of intracranial hemorrhage and fatal bleedings. They classified net clinical impact as the combination of the two.

Results showed the reduction of major ischemic events by ticagrelor occurred in the first week (4.1% vs. 5.3%; absolute risk reduction = 1.15%; 95% CI, 0.36-1.94) and remained through 30 days. In addition, researchers observed an increase in major hemorrhage during the first week, which remained relatively constant in subsequent weeks (absolute risk increase = 0.3%). Cumulative analysis also showed that net clinical impact favored the ticagrelor-aspirin group within the first week (aRR = 0.97%; 95% CI, 0.17-1.77) and remained constant through the treatment period.

“This analysis does not support shortening the 30-day regimen of (dual anti-platelet therapy) with ticagrelor and aspirin, and shorter treatment period has not been studied,” Wang and colleagues wrote.