Key result
Deescalating ticagrelor to clopidogrel cuts major events ~46% vs continuation in AMI patients with BMI <28.
Why the study?
The potential benefits of P2Y12 inhibitor deescalation after acute myocardial infarction treated with PCI may be influenced by body mass index (BMI).
Does a deescalation strategy of switching from ticagrelor to clopidogrel improve clinical outcomes in stabilized patients with acute myocardial infarction after percutaneous coronary intervention, and is this effect modified by BMI?
RCT (n=2,686)
randomized
Yes
Does a deescalation strategy of switching from ticagrelor to clopidogrel improve clinical outcomes in stabilized patients with acute myocardial infarction after percutaneous coronary intervention, and is this effect modified by BMI?
An unguided deescalation strategy from ticagrelor to clopidogrel 1 month after AMI PCI improves net clinical outcomes primarily by reducing bleeding in patients with BMI <28, but not in those with BMI ≥28.
Importance: The potential benefits of P2Y12 inhibitor deescalation for acute myocardial infarction after percutaneous coronary intervention may be influenced by body mass index (BMI). Objectives: To investigate the association of BMI on deescalation outcomes after 12 months in patients with acute myocardial infarction after percutaneous coronary intervention who were initially treated with aspirin plus ticagrelor for 1 month, and to assess whether BMI-based switching from aspirin plus ticagrelor (active control strategy) to aspirin plus clopidogrel (deescalation strategy) is associated with individualized benefits. Design, Setting, and Participants: This study is a post hoc analysis, based on BMI, of data from the TALOS-AMI (Ticagrelor vs Clopidogrel in Stabilized Patients with Acute Myocardial Infarction) randomized clinical trial. Data were collected from February 14, 2014, to December 31, 2018, with follow-up to January 21, 2021. Analyses were conducted from December 1, 2021, to August 21, 2024. Among 2697 trial participants from 32 centers in South Korea, 2686 participants whose BMI data were available were included. Exposure: All patients received aspirin plus ticagrelor for 1 month after percutaneous coronary intervention. Stabilized patients were then randomized to either the active control or deescalation strategy for an additional 11 months. Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, and Bleeding Academic Research Consortium bleeding type 2, 3, or 5 at 12 months after percutaneous coronary intervention. The trial compared the active control and deescalation strategies according to BMIs, including an interaction test. Results: Of the 2686 patients included (mean [SD] age, 60.0 [11.4] years; 2234 [83.2%] male), 2344 (1161 in the deescalation group and 1183 in the active control group) had a BMI less than 28, and 342 (184 in the deescalation group and 158 in the active control group) had a BMI of 28 or greater. The deescalation strategy was associated with significantly reduced composite outcomes compared with the active control strategy in the group with a BMI less than 28 (53 [4.6%] vs 98 [8.3%]; adjusted hazard ratio, 0.54; 95% CI, 0.39-0.76; P < .001), primarily due to fewer bleeding complications. There was no association in the group with a BMI of 28 or greater (6 [3.3%] vs 5 [3.2%]; adjusted hazard ratio, 1.07; 95% CI, 0.33-3.50; P = .91). Conclusions and Relevance: In this post hoc analysis of the TALOS-AMI randomized clinical trial, in stabilized patients with acute myocardial infarction, an unguided deescalation strategy of switching from ticagrelor to clopidogrel after 1 month was associated with better clinical outcomes in those with lower BMIs. Trial Registration: ClinicalTrials.gov Identifier: NCT02018055.
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Bu et al. (2025) conducted an RCT in acute myocardial infarction (n=2,686). Deescalation strategy (aspirin plus clopidogrel) vs. Active control strategy (aspirin plus ticagrelor) was evaluated on composite of cardiovascular death, myocardial infarction, stroke, and Bleeding Academic Research Consortium bleeding type 2, 3, or 5 at 12 months after percutaneous coronary intervention (adjusted HR 0.54, 95% CI 0.39-0.76, p=<.001). Deescalation from ticagrelor to clopidogrel reduced the primary composite outcome compared to continuing ticagrelor in AMI patients with BMI <28 (4.6% vs 8.3%; HR 0.54; 95% CI 0.39-0.76; P<0.001).
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