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Randomized Controlled Trial
. 2025 Feb 3;8(2):e2461916.
doi: 10.1001/jamanetworkopen.2024.61916.

BMI and Deescalation From Ticagrelor to Clopidogrel in Patients With Acute Myocardial Infarction: A Post Hoc Analysis of the TALOS-AMI Trial

Seonghyeon Bu  1   2 , Chan Joon Kim  1 , Sungmin Lim  1 , Jaehyuk Jang  1 , Mahn-Won Park  3 , Ik Jun Choi  4 , Donggyu Moon  5 , Byung-Hee Hwang  6 , Eun Ho Choo  6 , Kwan Yong Lee  6 , Yun Seok Choi  6 , Hee-Yeol Kim  7 , Ki-Dong Yoo  5 , Doo Soo Jeon  4 , Kiyuk Chang  2   6 ; TALOS-AMI investigators
Collaborators, Affiliations
Randomized Controlled Trial

BMI and Deescalation From Ticagrelor to Clopidogrel in Patients With Acute Myocardial Infarction: A Post Hoc Analysis of the TALOS-AMI Trial

Seonghyeon Bu et al. JAMA Netw Open. .

Erratum in

  • Error in Figure 1.
    [No authors listed] [No authors listed] JAMA Netw Open. 2025 Apr 1;8(4):e258167. doi: 10.1001/jamanetworkopen.2025.8167. JAMA Netw Open. 2025. PMID: 40168030 Free PMC article. No abstract available.

Abstract

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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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Spline Curve of the Event Rates
The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, and Bleeding Academic Research Consortium (BARC) bleeding type 2, 3, or 5 from 1 to 12 months after percutaneous coronary intervention. Major adverse cardiac event (MACE) is defined as the composite of cardiovascular death, stroke, and myocardial infarction. BARC bleeding comprises bleeding event type 2, 3, or 5 according to the BARC criteria. BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared).
Figure 2.
Figure 2.. Kaplan-Meier Estimates for Patients With Body Mass Index Less Than 28
The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, and Bleeding Academic Research Consortium (BARC) bleeding type 2, 3, or 5 from 1 to 12 months after percutaneous coronary intervention. Major adverse cardiac event (MACE) is defined as the composite of cardiovascular death, stroke, and myocardial infarction. BARC bleeding comprises bleeding event type 2, 3, or 5 according to the BARC criteria.
Figure 3.
Figure 3.. Kaplan-Meier Estimates for Patients With Body Mass Index of 28 or Greater
The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, and Bleeding Academic Research Consortium (BARC) bleeding type 2, 3, or 5 from 1 to 12 months after percutaneous coronary intervention. Major adverse cardiac event (MACE) is defined as the composite of cardiovascular death, stroke, and myocardial infarction. BARC bleeding comprises bleeding event type 2, 3, or 5 according to the BARC criteria.
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References

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