The TALOS AMI study suggests DAPT de-escalation 30 days after PCI was associated with lower rates of bleeding and the study's composite endpoint of cardiovascular death, MI, or stroke.
Data from an open-label, multicenter trial conducted in South Korea suggests switching from ticagrelor to clopidogrel 30 days after revascularization may be a safer and more effective management strategy in patients with acute myocardial infarction (MI).
Named TALOS AMI, the study found de-escalation of dual antiplatelet therapy (DAPT) after the first 30 days was associated with a 31% reduction in risk of cardiovascular death, MI, and stroke and a 48% reduction in risk of a major bleeding event.
“We found that the higher-potency DAPT regimen with ticagrelor was needed only during the first 30 days after a heart attack, when the risks of another heart attack or arterial blockage are highest, and that this regimen may be harmful once this early phase has passed,” said Kiyuk Chang, MD, professor of Cardiology, Division of Internal Medicine at the Catholic University of Korea in Seoul, who presented the results the American College of Cardiology’s 70th Annual Scientific Session (ACC.21), in a statement. “Many cardiologists are already using DAPT de-escalation in patient treatment, and the results of this study provide scientific evidence to justify this practice.”
Funded by Chong Kun Dang Pharm, TALOS AMI enrolled acute MI patients without adverse events after the first 30 days following PCI and randomized them in a 1:1 ratio to aspirin 100 mg plus clopidogrel 75 mg daily or aspirin 100 mg plus ticagrelor 90 mg twice daily. The largest trial of its kind to date, 2697 patients underwent randomization and 1349 and 1348 patients were assigned to the clopidogrel and ticagrelor DAPT groups, respectively.
Of note, de-escalation protocol for the study called for uniform, unguided de-escalation. Patients began taking clopidogrel 75 mg without loading dose approximately 12 hours after the final dose of ticagrelor.
The primary endpoint of the trial was defined as a composite of cardiovascular death, MI, stroke, or bleeding type 2, 3, or 5 according to BARC criteria within the first year from index PCI. Secondary endpoints for the study included a composite of cardiovascular death, MI, or stroke, a composite of BARC bleeding type 2, 3, or 45, and a composite of CV death, MI, stroke, or BARC bleeding type 3 or 5.
In their analyses, investigators found a primary endpoint event occurred among 4.6% of patients receiving clopidogrel and 8.2% patients receiving ticagrelor (HR, 0.55; 95% CI, 0.40-0.76). When assessing secondary endpoints, investigators found de-escalation with clopidogrel was associated with a 31% reduction in risk of the composite of cardiovascular death, MI, and stroke. Additionally, clopidogrel use was also associated with a 48% reduction in risk for the composite of BARC bleeding type 2, 3, or 5 (HR, 0.52; 95% CI, 0.35-0.77).
During his presentation, Chang noted the incidence of primary endpoint events was lower than investigators had initially estimated. Specifically, the rate of events in the de-escalation group was 4.6% versus the expected 9.59% and the rate in the ticagrelor group was 8.2% versus the expected 9.35%.
“We have shown that, in patients who have had a heart attack and who’ve been treated with newer-generation stents and guideline-recommended medical therapy, de-escalation of DAPT by switching from ticagrelor to clopidogrel is completely safe and more effective than continuing to treat patients with ticagrelor,” Chang added.
This study, “A Prospective, Multicenter, Randomized, Open-label Trial to Compare Efficacy and Safety Of Clopidogrel Versus Ticagrelor In Stabilized Patients With Acute Myocardial Infarction After Percutaneous Coronary Intervention,” was presented at ACC.21.