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Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial

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Author(s)
Duk-Woo ParkOsung KwonJae-Sik JangSung-Cheol YunHanbit ParkDo-Yoon KangJung-Min AhnPil Hyung LeeSeung-Whan LeeSeong-Wook ParkSi Wan ChoiSang-Gon LeeHyuck-Jun YoonTaehoon AhnMoo Hyun KimDeuk Young NahSung Yun LeeJei Keon ChaeSeung-Jung Park
Keimyung Author(s)
Yoon, Hyuck Jun
Department
Dept. of Internal Medicine (내과학)
Journal Title
Circulation
Issued Date
2019
Volume
140
Issue
23
Keyword
acute coronary syndromeclopidogrelticagrelor
Abstract
BACKGROUND:
Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain.

METHODS:
In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months.

RESULTS:
At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P=0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P=0.04) and fatal bleeding (1% [4/400] vs 0%, P=0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P=0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups.

CONCLUSIONS:
In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy
Keimyung Author(s)(Kor)
윤혁준
Publisher
School of Medicine (의과대학)
Citation
Duk-Woo Park et al. (2019). Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial. Circulation, 140(23), 1865–1877. doi: 10.1161/CIRCULATIONAHA.119.041766
Type
Article
ISSN
1524-4539
Source
https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.119.041766
DOI
10.1161/CIRCULATIONAHA.119.041766
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42331
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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