The preference for the use of potent P2Y12 inhibitors such as ticagrelor and prasugrel in patients with high risk of acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is based on randomized studies and current guideline recommendations. However, clopidogrel is still recommended for patients at high risk of bleeding. Several strategies have been looked into to balance thrombotic and bleeding risk.
The TALOS AMI (TicAgrelor Versus CLOpidogrel in Stabilized Patients with Acute Myocardial Infarction) looked into de-escalating from ticagrelor to clopidogrel one month after AMI, showing a reduction in bleeding events vs. the standard 12-month ticagrelor therapy.
The aim of this substudy of the TALOS AMI (a multicenter, randomized, non-inferiority study) was to examine the efficacy and safety of de-escalating from ticagrelor to clopidogrel after PCI, taking into account bleeding risk.
Primary end point was defined as incidence of clinical adverse events, including cardiovascular death, AMI, stroke and BARC bleeding types 3 or 5. The secondary end point focused on BARC bleeding types 3 or 5. The study also included other secondary points such as major adverse cardiac and cerebrovascular events (MACCE), BARC bleeding types 2, 3 or 5, all cause death, cardiovascular death, AMI, ischemia driven revascularization and stent thrombosis.
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22.4% of analyzed patients, (589 patients) presented high risk of bleeding (HBR), while 77.6% (2036 patients) did not. The HBR patients were older, with a bigger proportion of women. They also presented a higher incidence of hypertension, diabetes, prior PCI, stroke and ejection fraction lower than 40%. In both groups, the most affected coronary artery was the anterior descending and HBR patients received multivessel treatment more frequently, vs. non-HBR patients (P=0.034).
Primary end point incidence was significantly higher in the HBR group (8.7% vs 5.2%, HR 1.75, CI 95%: 1.26-2.45; P=0.001). BARC bleeding 2, 3 or 5, was more frequent in the HBR group (2.5% vs 1.3%, HR: 2.01, CI 95%: 1.07-3.78; P=0.030). Also, MACCE, BARC bleeding 3 or 5, all cause death, cardiovascular and AMI incidence were higher in this same group. There were no differences in the incidence of stroke, ischemia driven revascularization or thrombosis stent.
Conclusion
De-escalating from ticagrelor to clopidogrel 1 month after AMI resulted safe and effective in terms of a lower rate of clinical adverse events, irrespective of bleeding risk. Also, this strategy was showed more effective in reducing BARC bleeding types 3 or 5 among patients at high bleeding risk. Therefore, de-escalating from ticagrelor to clopidogrel could be considered a reasonable option in AMI patients at high risk of bleeding.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: De-escalation from ticagrelor to clopidogrel in patients with acute myocardial infarction: the TALOS-AMI HBR substudy.
Reference: Min Chul Kim1 , MD, PhD et al EuroIntervention 2023;19.
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