TICO-STEMI: Opening the door for Ticagrelor monotherapy in patients after STEMI?
Reported from the TCT Congress 2020
At TCT Connect 2020, Byeong-Keuk Kim presented the results of the TICO-STEMI, from the randomized TICO trial of ticagrelor monotherapy vs ticagrelor with aspirin in ACS. Dejan Milasinovic provides a summary of the key messages.
The TICO trial evaluated the effects of Ticagrelor monotherapy after 3 months of initial DAPT in patients with ACS. The results of TICO-STEMI, a prespecified analysis in patients with STEMI, were in concert with the overall trial results, which suggested that dropping Aspirin after the initial 3 months of Ticagrelor-based DAPT is associated with less bleeding and no difference in MACE, when compared with a standard 12-month DAPT regimen.
What to consider when translating results into practice
At first glance, there appear to be at least 3 issues that should be considered when translating the results of TICO-STEMI into clinical practice.
First, patients were randomized to Ticagrelor monotherapy (after 3 months of DAPT) vs. 12-month DAPT at the time of index STEMI. This is not entirely reflective of the clinical decision-making that often demands reassessing bleeding vs. ischemic risks after a fixed course of DAPT. In addition, given that both study arms received the same DAPT regimen in the initial 3 months, any difference in the occurrence of adverse events in this period is likely due to play of chance or perhaps inherent differences in the baseline risk. This is relevant, as judging from the reported Kaplan Meier curves, there seems to be an excess (at least numerical) of both ischemic and bleeding events in the first 3 months in the 12-month DAPT group. That being said, a landmark analysis did confirm neutrality in terms of post-3-month ischemic events and a benefit in terms of bleeding events for the same period in patients with Ticagrelor monotherapy.
Second, low overall rates of both MACE (around 2.5% at 12 months) and major bleeding (around 2%, with 0% in the Ticagrelor-only group after 3 months) suggest a lower-risk population of STEMI included in this study compared with the real world.
Third, there was no significant interaction between neither PRECISE DAPT-assessed high bleeding risk nor complex PCI (as a maker of increased ischemic risk) and the effects of Ticagrelor monotherapy on bleeding events or MACE, respectively. Nevertheless, the numerically highest rates of bleeding were observed in patients on 12-month DAPT regimen who were deemed to be of high bleeding risk according to the PRECISE DAPT score. Also, MACE was the most frequent in the group of patients with complex PCI and treated with Ticagrelor alone after 3 months.
Highlighting the need for an optimal distinction between the risk factors of bleeding and ischemia in post-PCI patients
Taken together, the observations from TICO-STEMI appear to further highlight the need for optimal distinction between the risk factors of bleeding and ischemia in post-PCI patients. This is not an easy endeavour given the documented overlap between the two. However, it is a goal worth pursuing, as a proper stratification tool may have the capacity to improve prognosis given that both thrombotic and bleeding events are associated with increased mortality.
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