TALOS-AMI clinical trial review

TALOS-AMI clinical trial review

TALOS-AMI (TicAgrelor Versus CLOpidogrel in Stabilized Patients With Acute Myocardial Infarction) was an investigator initiated open label, assessor masked, multicentre, non-inferiority, randomized trial which assessed unguided de-escalation from ticagrelor to clopidogrel in stabilized patients with acute myocardial infarction undergoing coronary intervention. Patients receiving aspirin and ticagrelor without major ischemic or bleeding events during the first month after index percutaneous coronary intervention were randomized to de-escalation to clopidogrel plus aspirin or ticagrelor plus aspirin. No loading dose of clopidogrel was used [1].

Primary end point in the TALOS-AMI trial was a composite of cardiovascular death, myocardial infarction, stroke or bleeding type 2,3, or 5 according to Bleeding Academic Research Consortium criteria from 1 to 12 months. There were 1349 patients in the de-escalation group and 1348 patients in the active control group. There was no difference in the composite of cardiovascular death, myocardial infarction or stroke between the two groups at 12 months. But bleeding was less frequent in the de-escalation group with P=0.0012. Authors concluded that in stabilized patients with acute myocardial infarction after index PCI, unguided de-escalation to clopidogrel plus aspirin significantly reduced the risk of net clinical events up to 12 months, mainly by reducing bleeding events.

Interestingly, there are some similarities between TALOS-AMI and HOST-EXAM (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy) trial, another trial which showed benefit with clopidogrel [2]. Both were investigator initiated, open label trials from the same geographic region and published in the same journal. While TALOS-AMI showed an advantage over ticagrelor, HOST-EXAM showed an advantage over aspirin. The rationale for the TALOS-AMI trial was that ischemic complications are highest in the early phase while bleeding events occur predominantly in the maintenance phase. There was only limited data on de-escalation of dual anti-platelet therapy by switching from ticagrelor to clopidogrel in stabilized patients after index PCI after acute myocardial infarction [3]. What we now need is a blinded study involving multiple geographical regions, on the same aspect, to establish the evidence on a firmer footing.

References

1. Kim CJ, Park MW, Kim MC, Choo EH, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Shin ES, Jeong YH, Seung KB, Jeong MH, Yim HW, Ahn Y, Chang K; TALOS-AMI investigators. Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial. Lancet. 2021 Oct 9;398(10308):1305-1316. doi: 10.1016/S0140-6736(21)01445-8. PMID: 34627490.
2. Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16. PMID: 34010616.
3. Park MW, Kim CJ, Kim MC, Choo EH, Hwang BH, Park CS, Kim HY, Yoo KD, Jeon DS, Jeong MH, Seung KB, Ahn Y, Chang K. A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALOS-AMI trial. EuroIntervention. 2021 Feb 19;16(14):1170-1176. doi: 10.4244/EIJ-D-20-00187. PMID: 32718912.