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

Jeong, Young‐Hoon; Jeong, Myung Ho; Yim, Hyeon Woo; Kim, Chan Joon; Park, Mahn‐Won; Kim, Min Chul; Choo, Eun Ho; Hwang, Byung‐Hee; Lee, Kwan Yong; Choi, Yun Seok; Kim, Hee-Yeol; Yoo, Ki‐Dong; Jeon, Doo-Soo; Shin, Eun‐Seok; Jeong, Yong‐Hoon; Seung, Ki‐Bae; Jeon, Myung Ho; Ahn, Youngkeun; Chang, Kiyuk; Oh, Ju‐Hyeon; Ha, Sang Jin; Baek, Ju Yeol; Jung, Kyung Tae; Doh, Joon‐Hyung; Kim, Won; Kim, Dong‐Bin; Soo, Kwang; Yoon, Myeong‐Ho; Hur, Seung‐Ho; Lee, Seung Hwan; Cho, Byung Ryul; Park, Jong Seon; Koh, Jin Shin; Kim, Sang-Hyun; Cho, Jang Hyun; Shim, Bong Suk; Kim, Sang Wook; Jang, Jae‐Sik; Kim, Kee‐Sik; Shin, Won-Yong; Sung, Ki‐Chul

doi:10.1016/s0140-6736(21)01445-8

Cited by 99 publications

(93 citation statements)

References 37 publications

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“…Figure 1 depicts the treatment sequel in each arm of the included studies. Three studies evaluated non-guided deescalation vs conventional treatment with ticagrelor/prasugrel (19,21,22,35) (N=3,473). In these three studies on de-escalation, the mean timing of the switch to clopidogrel was 25 days after PCI.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…In these three studies on de-escalation, the mean timing of the switch to clopidogrel was 25 days after PCI. (19,21,22,35) Three studies considered a guided clopidogrel therapy (N=7,533): two a genotype-guided clopidogrel therapy vs conventional treatment with ticagrelor/prasugrel (16,20), whereas one (TROPICAL ACS) compared a platelet function testing-guided (by the Multiplate Analyser, Roche Diagnostics, Rotkreuz, Switzerland) de-escalation from prasugrel to clopidogrel two weeks after PCI vs conventional treatment with prasugrel (17). Patients with ACS only were enrolled in four trials (16,17,19,21,35) and patients with either ACS or chronic coronary syndrome in the remaining two (20,22).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…Based on the study design, from TROPICAL ACS we considered the guided de-escalation group on clopidogrel without high residual platelet reactivity vs conventional treatment on prasugrel (control group plus guided group with high platelet reactivity on clopidogrel) (17). Follow-up duration was 12 months in five investigations (16,17,(19)(20)(21)35) and 1•5 months in the study by Ueno et al (22). The overall mean duration was 10•3 months.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

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Safety and Efficacy of Selective, Clopidogrel-Based Strategies in Acute Coronary Syndrome: A Study-Level Meta-analysis

et al. 2022

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Objectives. To investigate outcome with selective, clopidogrel-based therapies vs conventional treatment in patients undergoing percutaneous coronary intervention (PCI), especially for acute coronary syndrome. Background. Safety and efficacy of alternative, selective, clopidogrel-based therapies after PCI are not robustly established. Methods. We performed a study-level meta-analysis on six randomized trials investigating selective clopidogrel-based therapies (three on unguided de-escalation, N=3,473; three on guided clopidogrel therapy, N=7,533). Control groups received ticagrelor or prasugrel treatment. Main endpoints were major bleeding, any bleeding, major adverse cardiovascular events (MACE) and net clinical endpoint. Results. The incidence of major bleeding and MACE was similar in the selective, clopidogrel-based therapy vs conventional treatment arm (OR 0·72, 95% CI 0·51-1·01, p=0·06; OR 0·93, 0·72-1·20, p=0·58; respectively). The rates of any bleeding were lower in the selective, clopidogrel-based therapy vs conventional treatment group (OR 0·57, 0·40-0·80, p=0·001); this greater safety was significant for unguided de-escalation (OR 0·43, 0·32-0·58, p=0·00001) and non-significant for guided clopidogrel therapy (OR 0·72, 0·51-1·02, p=0·07; p for interaction 0·03). The incidence of the net clinical endpoint was fewer in the selective, clopidogrel-based therapy vs conventional treatment arm (OR 0·59, 0·41-0·85, p=0·004); this benefit was significant for unguided de-escalation (OR 0·50, 0·39-0·64, p<0·00001) and non-significant for guided clopidogrel therapy (OR 0·85, 0·62-1·16, p=0·30; p for interaction 0·01). Conclusions. As compared with prasugrel/ticagrelor treatment, alternative, selective, clopidogrel-based approaches provide a similar protection from cardiovascular events, reduce the risk of any bleeding and are associated with a greater net benefit. These beneficial effects were prevalent with unguided de-escalation to clopidogrel.

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Section: Accepted Manuscriptmentioning

confidence: 99%

Section: Accepted Manuscriptmentioning

confidence: 99%

Section: Accepted Manuscriptmentioning

confidence: 99%

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Safety and Efficacy of Selective, Clopidogrel-Based Strategies in Acute Coronary Syndrome: A Study-Level Meta-analysis

et al. 2022

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“…Our analysis showed that in patients with ACS post PCI, unguided DAPT de-escalation strategy was associated with a higher net clinical benefits in comparison to continuation strategy with more potent P2Y12 inhibitors, Our results are consistent with current evidence. 3,4 The superiority of the potent P2Y 12 inhibitors (ticagrelor, prasugrel) over (clopidogrel) has been demonstrated in ACS patients mainly in the acute phase, because of greater ischemic benefit, but there is an associated increased risk of bleeding after that. Therefore, superiority of (ticagrelor, prasugrel) beyond 30 days of cardiac events is questionable.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…clinical practice. 3,4 Therefore, we conducted a meta-analysis of randomized clinical trials to investigate the unguided de-escalation of DAPT in ACS patients undergoing PCI.…”

mentioning

confidence: 99%

Meta-analysis of Unguided Deescalation of Dual Antiplatelet Therapy in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Mohamed

Shaikh

Kheiri

2022

TH Open

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Dual Antiplatelet Therapy De-Escalation in Stabilized Myocardial Infarction With High Ischemic Risk

Lee,

Byun,

Lim

et al. 2024

JAMA Cardiol

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ImportanceIn patients with acute myocardial infarction (AMI) who have high ischemic risk, data on the efficacy and safety of the de-escalation strategy of switching from ticagrelor to clopidogrel are lacking.ObjectiveTo evaluate the outcomes of the de-escalation strategy compared with dual antiplatelet therapy (DAPT) with ticagrelor in stabilized patients with AMI and high ischemic risk following percutaneous coronary intervention (PCI).Design, Setting, and ParticipantsThis was a post hoc analysis of the Ticagrelor vs Clopidogrel in Stabilized Patients With Acute Myocardial Infarction (TALOS-AMI) trial, an open-label, assessor-blinded, multicenter, randomized clinical trial. Patients with AMI who had no event during 1 month of ticagrelor-based DAPT after PCI were included. High ischemic risk was defined as having a history of diabetes or chronic kidney disease, multivessel PCI, at least 3 lesions treated, total stent length greater than 60 mm, at least 3 stents implanted, left main PCI, or bifurcation PCI with at least 2 stents. Data were collected from February 14, 2014, to January 21, 2021, and analyzed from December 1, 2021, to June 30, 2022.InterventionPatients were randomly assigned to either de-escalation from ticagrelor to clopidogrel or ticagrelor-based DAPT.Main Outcomes and MeasuresIschemic outcomes (composite of cardiovascular death, myocardial infarction, ischemic stroke, ischemia-driven revascularization, or stent thrombosis) and bleeding outcomes (Bleeding Academic Research Consortium type 2, 3, or 5 bleeding) were evaluated.ResultsOf 2697 patients with AMI (mean [SD] age, 60.0 [11.4] years; 454 [16.8%] female), 1371 (50.8%; 684 assigned to de-escalation and 687 assigned to ticagrelor-based DAPT) had high ischemic risk features and a significantly higher risk of ischemic outcomes than those without high ischemic risk (1326 patients [49.2%], including 665 assigned to de-escalation and 661 assigned to ticagrelor-based DAPT) (hazard ratio [HR], 1.74; 95% CI, 1.15-2.63; P = .01). De-escalation to clopidogrel, compared with ticagrelor-based DAPT, showed no significant difference in ischemic risk across the high ischemic risk group (HR, 0.88; 95% CI, 0.54-1.45; P = .62) and the non–high ischemic risk group (HR, 0.65; 95% CI, 0.33-1.28; P = .21), without heterogeneity (P for interaction = .47). The bleeding risk of the de-escalation group was consistent in both the high ischemic risk group (HR, 0.64; 95% CI, 0.37-1.11; P = .11) and the non–high ischemic risk group (HR, 0.42; 95% CI, 0.24-0.75; P = .003), without heterogeneity (P for interaction = .32).Conclusions and RelevanceIn stabilized patients with AMI, the ischemic and bleeding outcomes of an unguided de-escalation strategy with clopidogrel compared with a ticagrelor-based DAPT strategy were consistent without significant interaction, regardless of the presence of high ischemic risk.

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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

Cited by 99 publications

References 37 publications

Safety and Efficacy of Selective, Clopidogrel-Based Strategies in Acute Coronary Syndrome: A Study-Level Meta-analysis

Safety and Efficacy of Selective, Clopidogrel-Based Strategies in Acute Coronary Syndrome: A Study-Level Meta-analysis

Meta-analysis of Unguided Deescalation of Dual Antiplatelet Therapy in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Dual Antiplatelet Therapy De-Escalation in Stabilized Myocardial Infarction With High Ischemic Risk

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