TALOS-AMI - TALOS-AMI
Contribution To Literature:
The TALOS-AMI trial showed that among patients undergoing PCI for AMI and who had completed 1 month of DAPT with aspirin and ticagrelor uneventfully, switching to aspirin + clopidogrel for the next 11 months met criteria for noninferiority and superiority compared with continuing with aspirin + ticagrelor.
The goal of the trial was to assess whether de-escalating dual antiplatelet therapy (DAPT) with clopidogrel rather than ticagrelor 1 month after percutaneous coronary intervention (PCI) for an acute myocardial infarction (AMI) would be a noninferior strategy.
After successful PCI for AMI, all patients received aspirin + ticagrelor for 30 ± 7 days. Patients without adverse events were randomized to continuing DAPT in a 1:1 open-label fashion with either aspirin + clopidogrel 75 mg daily (de-escalation, n = 1,349) or aspirin + ticagrelor 90 mg BID (n = 1,348). In the de-escalation arm, clopidogrel was administered without a loading dose.
- Total screened: 2,901
- Total number of enrollees: 2,697
- Duration of follow-up: 12 months
- Mean patient age: 60 years
- Percentage female: 17%
- PCI for AMI
- No adverse events for 30 days post-PCI
Other salient features/characteristics:
- Diabetes mellitus: 27%
- Previous myocardial infarction (MI): 16%
- Index PCI: non–ST-segment elevation MI (NSTEMI): 46%, STEMI: 54%
- Infarct-related artery left anterior descending: 49%
- Multivessel PCI: 27%
The primary endpoint of cardiovascular death, MI, stroke, Bleeding Academic Research Consortium (BARC) bleeding 2,3, or 5, for de-escalation vs. active control between 1 and 12 months post-PCI, was: 4.6% vs. 8.2% (p for noninferiority < 0.001, p for superiority < 0.001).
- Cardiovascular death, MI, stroke: 2.1% vs. 3.1% (p = 0.15)
- BARC 2,3, or 5 bleeding: 3% vs. 5.6% (p = 0.001)
The results of this trial indicate that among patients undergoing PCI for AMI and who had completed 1 month of DAPT with aspirin and ticagrelor uneventfully, switching to aspirin + clopidogrel for the next 11 months met criteria for noninferiority and superiority compared with continuing with aspirin + ticagrelor. This was primarily driven by a reduction in major bleeding, but ischemic events were also numerically lower with a de-escalation strategy. De-escalation was performed without genotype testing or reload. These are interesting data and are likely to be clinically relevant and cost-effective. The only caveat is that this trial only included East Asian patients, so the generalizability in the United States is unclear.
We have seen several interesting trials in the DAPT space in the past few years. Trials such as TWILIGHT have shown that it may be possible to continue ticagrelor monotherapy and drop aspirin after 3 months with no penalty in ischemic outcomes and a reduction in bleeding outcomes among patients undergoing PCI. Similarly, STOPDAPT-2 suggested that clopidogrel monotherapy could be continued after 1 month in patients undergoing PCI for stable ischemic heart disease and ACS. In HOST-REDUCE-POLYTECH-ACS, switching to prasugrel 5 mg daily after 1 month was superior to continuing with prasugrel 10 mg daily.
Presented by Dr. Kiyuk Chang at the American College of Cardiology Virtual Annual Scientific Session (ACC 2021), May 16, 2021.
Keywords: ACC21, ACC Annual Scientific Session, Acute Coronary Syndrome, Aspirin, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Stroke
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