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Background <p>The clinical benefits of prasugrel compared to clopidogrel in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) are well established. However, significant safety concerns persist, particularly in elderly (≥ 75 years) or low-weight (&lt; 60&#xa0;kg) patients, even with reduced-dose prasugrel. We aimed to evaluate the comparative effectiveness and safety of prasugrel versus clopidogrel after PCI in Korean ACS patients, focusing on elderly or low-weight subgroup.</p> Methods <p>We performed post-hoc analysis of data from the EFF-K and COREA-AMI II registries, including 3,744 prasugrel- and 9,588 clopidogrel-treated patients post-PCI. Propensity score (PS) matching created 3,725 patients per treatment arm to compare 1-year primary effectiveness (major adverse cardiac and cerebrovascular events [MACCE]: all-cause death, myocardial infarction, stroke, stent thrombosis, and any revascularization) and safety (Thrombolysis in Myocardial Infarction [TIMI] major or minor bleeding) outcomes. Subgroup analyses focused on age and weight of patients.</p> Results <p>Among PS-matched patients, including 18.5% in the elderly (age ≥ 75 years) or low-body-weight (&lt; 60&#xa0;kg) (ELB) subgroup, the 1-year incidence of MACCE was significantly lower in the prasugrel arm (3.0% vs. 8.3%, HR 0.39, 95% CI 0.32–0.49, <i>P</i> &lt; .001), with comparable TIMI bleeding rates (2.8% vs. 3.2%, HR 0.91, 95% CI 0.70–1.19, <i>P</i> = .495). In the ELB subgroup, 50.8% received 5&#xa0;mg prasugrel. Prasugrel use was associated with a lower risk of MACCE (4.4% vs. 8.6%, HR 0.56, 95% CI 0.36–0.86, <i>P</i> = .009) without a significantly increased risk of bleeding (3.6% vs. 5.8%, HR 0.66, 95% CI 0.40–1.10, <i>P</i> = .111).</p> Conclusions <p>In this Korean PS-matched ACS cohort, prasugrel, even at a reduced dose, was associated with superior effectiveness compared to clopidogrel without a significant increase in bleeding risk. These benefits were consistently observed in ELB patients. Our findings support the use of prasugrel in selected high-risk populations and offer guidance for clinical practice.</p> Registration <p>EFF-K, Cris.nih.go.kr, Identifier: KCT0002356, registered June 13, 2017.&#xa0;COREA-AMI II, Clinicaltrials.gov, Identifier: NCT02806102, registered May 31, 2016</p>

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The efficacy and safety of prasugrel in acute coronary syndrome: a propensity-matched Korean cohort study focused on age and weight of patients

  • 期刊论文

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  • 发表日期：

    2025年11月26日

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  • Sang Hyun Kim,
  • Eun Ho Choo,
  • Jeehoon Kang,
  • Jong-Min Lee,
  • Ki-Dong Yoo,
  • Mahn-Won Park,
  • Chul Soo Park,
  • Hee-Yeol Kim,
  • Min Chul Kim,
  • Youngkeun Ahn,
  • Kiyuk Chang,
  • Hyo-Soo Kim

摘要

Background

The clinical benefits of prasugrel compared to clopidogrel in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) are well established. However, significant safety concerns persist, particularly in elderly (≥ 75 years) or low-weight (< 60 kg) patients, even with reduced-dose prasugrel. We aimed to evaluate the comparative effectiveness and safety of prasugrel versus clopidogrel after PCI in Korean ACS patients, focusing on elderly or low-weight subgroup.

Methods

We performed post-hoc analysis of data from the EFF-K and COREA-AMI II registries, including 3,744 prasugrel- and 9,588 clopidogrel-treated patients post-PCI. Propensity score (PS) matching created 3,725 patients per treatment arm to compare 1-year primary effectiveness (major adverse cardiac and cerebrovascular events [MACCE]: all-cause death, myocardial infarction, stroke, stent thrombosis, and any revascularization) and safety (Thrombolysis in Myocardial Infarction [TIMI] major or minor bleeding) outcomes. Subgroup analyses focused on age and weight of patients.

Results

Among PS-matched patients, including 18.5% in the elderly (age ≥ 75 years) or low-body-weight (< 60 kg) (ELB) subgroup, the 1-year incidence of MACCE was significantly lower in the prasugrel arm (3.0% vs. 8.3%, HR 0.39, 95% CI 0.32–0.49, P < .001), with comparable TIMI bleeding rates (2.8% vs. 3.2%, HR 0.91, 95% CI 0.70–1.19, P = .495). In the ELB subgroup, 50.8% received 5 mg prasugrel. Prasugrel use was associated with a lower risk of MACCE (4.4% vs. 8.6%, HR 0.56, 95% CI 0.36–0.86, P = .009) without a significantly increased risk of bleeding (3.6% vs. 5.8%, HR 0.66, 95% CI 0.40–1.10, P = .111).

Conclusions

In this Korean PS-matched ACS cohort, prasugrel, even at a reduced dose, was associated with superior effectiveness compared to clopidogrel without a significant increase in bleeding risk. These benefits were consistently observed in ELB patients. Our findings support the use of prasugrel in selected high-risk populations and offer guidance for clinical practice.

Registration

EFF-K, Cris.nih.go.kr, Identifier: KCT0002356, registered June 13, 2017. COREA-AMI II, Clinicaltrials.gov, Identifier: NCT02806102, registered May 31, 2016