Efficacy and safety of ticagrelor versus clopidogrel in acute coronary syndrome in Taiwan: A multicenter retrospective pilot study

on behalf of the ESTATE Investigators

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background The efficacy and safety of ticagrelor compared with clopidogrel in acute coronary syndrome has not previously been evaluated in an Eastern Asian population, which is recognized to have a different response to P2Y12 antagonists compared with the Caucasian population in real-life situations. Methods A multicenter retrospective pilot study was performed to evaluate 928 consecutive patients with acute coronary syndrome, receiving aspirin and one P2Y12 antagonist (324 ticagrelor or 604 clopidogrel). Using propensity score matching, 448 patients were selected and divided into two equal groups. Kaplan–Meier analysis was used to study patient survival and event-free status using the log-rank test. Independent covariates were identified using univariate in a multivariate Cox proportional hazard model. Results In the overall cohort, significant differences were observed for certain variables between the two groups. During the mean 164.3 (±116.4)-day follow-up in the overall cohort, ticagrelor treatment had no significant effect on the primary efficacy endpoint (myocardial infarction, stroke, or vascular death); however, in the matched cohort, ticagrelor showed a lower incidence of primary endpoint (hazard ratio: 0.56; 95% confidence interval: 0.30–1.04; p = 0.07) and stroke (hazard ratio: 0.15; 95% confidence interval: 0.02–1.24; p = 0.08) with marginal statistical significance, and a similar bleeding rate. The protective effect of ticagrelor treatment was consistent for all subgroups. More patients treated with ticagrelor experienced dyspnea (21.0% vs. 11.6%, p = 0.007), and P2Y12 antagonist treatment was consequently discontinued. Conclusion Ticagrelor treatment could provide a marginally favorable effect at the expense of an increased risk of dyspnea in real-life situations. This pilot study provides a scientific basis to call for a larger, suitably powered Phase 4 prospective or observational study in this ethnic population.

Original languageEnglish
Pages (from-to)521-530
Number of pages10
JournalJournal of the Chinese Medical Association
Volume79
Issue number10
DOIs
Publication statusPublished - 2016 Oct 1

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clopidogrel
Acute Coronary Syndrome
Taiwan
Retrospective Studies
Safety
Dyspnea
Stroke
Confidence Intervals
Population
Propensity Score
Therapeutics
Ticagrelor
Proportional Hazards Models
Aspirin
Disease-Free Survival
Observational Studies
Blood Vessels

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{2ab710c3675e4c1787d2033e91f3ab97,
title = "Efficacy and safety of ticagrelor versus clopidogrel in acute coronary syndrome in Taiwan: A multicenter retrospective pilot study",
abstract = "Background The efficacy and safety of ticagrelor compared with clopidogrel in acute coronary syndrome has not previously been evaluated in an Eastern Asian population, which is recognized to have a different response to P2Y12 antagonists compared with the Caucasian population in real-life situations. Methods A multicenter retrospective pilot study was performed to evaluate 928 consecutive patients with acute coronary syndrome, receiving aspirin and one P2Y12 antagonist (324 ticagrelor or 604 clopidogrel). Using propensity score matching, 448 patients were selected and divided into two equal groups. Kaplan–Meier analysis was used to study patient survival and event-free status using the log-rank test. Independent covariates were identified using univariate in a multivariate Cox proportional hazard model. Results In the overall cohort, significant differences were observed for certain variables between the two groups. During the mean 164.3 (±116.4)-day follow-up in the overall cohort, ticagrelor treatment had no significant effect on the primary efficacy endpoint (myocardial infarction, stroke, or vascular death); however, in the matched cohort, ticagrelor showed a lower incidence of primary endpoint (hazard ratio: 0.56; 95{\%} confidence interval: 0.30–1.04; p = 0.07) and stroke (hazard ratio: 0.15; 95{\%} confidence interval: 0.02–1.24; p = 0.08) with marginal statistical significance, and a similar bleeding rate. The protective effect of ticagrelor treatment was consistent for all subgroups. More patients treated with ticagrelor experienced dyspnea (21.0{\%} vs. 11.6{\%}, p = 0.007), and P2Y12 antagonist treatment was consequently discontinued. Conclusion Ticagrelor treatment could provide a marginally favorable effect at the expense of an increased risk of dyspnea in real-life situations. This pilot study provides a scientific basis to call for a larger, suitably powered Phase 4 prospective or observational study in this ethnic population.",
author = "{on behalf of the ESTATE Investigators} and Chen, {I. Chih} and Lee, {Cheng Han} and Fang, {Ching Chang} and Chao, {Ting Hsing} and Cheng, {Ching Lan} and Yi Chen and Yu, {Ching Lung} and Lin, {Chih Chan} and Lin, {Chun Yuan} and Li, {Yi Heng}",
year = "2016",
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doi = "10.1016/j.jcma.2016.02.010",
language = "English",
volume = "79",
pages = "521--530",
journal = "Journal of the Chinese Medical Association",
issn = "1726-4901",
publisher = "Elsevier Taiwan LLC",
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Efficacy and safety of ticagrelor versus clopidogrel in acute coronary syndrome in Taiwan : A multicenter retrospective pilot study. / on behalf of the ESTATE Investigators.

In: Journal of the Chinese Medical Association, Vol. 79, No. 10, 01.10.2016, p. 521-530.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of ticagrelor versus clopidogrel in acute coronary syndrome in Taiwan

T2 - A multicenter retrospective pilot study

AU - on behalf of the ESTATE Investigators

AU - Chen, I. Chih

AU - Lee, Cheng Han

AU - Fang, Ching Chang

AU - Chao, Ting Hsing

AU - Cheng, Ching Lan

AU - Chen, Yi

AU - Yu, Ching Lung

AU - Lin, Chih Chan

AU - Lin, Chun Yuan

AU - Li, Yi Heng

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Background The efficacy and safety of ticagrelor compared with clopidogrel in acute coronary syndrome has not previously been evaluated in an Eastern Asian population, which is recognized to have a different response to P2Y12 antagonists compared with the Caucasian population in real-life situations. Methods A multicenter retrospective pilot study was performed to evaluate 928 consecutive patients with acute coronary syndrome, receiving aspirin and one P2Y12 antagonist (324 ticagrelor or 604 clopidogrel). Using propensity score matching, 448 patients were selected and divided into two equal groups. Kaplan–Meier analysis was used to study patient survival and event-free status using the log-rank test. Independent covariates were identified using univariate in a multivariate Cox proportional hazard model. Results In the overall cohort, significant differences were observed for certain variables between the two groups. During the mean 164.3 (±116.4)-day follow-up in the overall cohort, ticagrelor treatment had no significant effect on the primary efficacy endpoint (myocardial infarction, stroke, or vascular death); however, in the matched cohort, ticagrelor showed a lower incidence of primary endpoint (hazard ratio: 0.56; 95% confidence interval: 0.30–1.04; p = 0.07) and stroke (hazard ratio: 0.15; 95% confidence interval: 0.02–1.24; p = 0.08) with marginal statistical significance, and a similar bleeding rate. The protective effect of ticagrelor treatment was consistent for all subgroups. More patients treated with ticagrelor experienced dyspnea (21.0% vs. 11.6%, p = 0.007), and P2Y12 antagonist treatment was consequently discontinued. Conclusion Ticagrelor treatment could provide a marginally favorable effect at the expense of an increased risk of dyspnea in real-life situations. This pilot study provides a scientific basis to call for a larger, suitably powered Phase 4 prospective or observational study in this ethnic population.

AB - Background The efficacy and safety of ticagrelor compared with clopidogrel in acute coronary syndrome has not previously been evaluated in an Eastern Asian population, which is recognized to have a different response to P2Y12 antagonists compared with the Caucasian population in real-life situations. Methods A multicenter retrospective pilot study was performed to evaluate 928 consecutive patients with acute coronary syndrome, receiving aspirin and one P2Y12 antagonist (324 ticagrelor or 604 clopidogrel). Using propensity score matching, 448 patients were selected and divided into two equal groups. Kaplan–Meier analysis was used to study patient survival and event-free status using the log-rank test. Independent covariates were identified using univariate in a multivariate Cox proportional hazard model. Results In the overall cohort, significant differences were observed for certain variables between the two groups. During the mean 164.3 (±116.4)-day follow-up in the overall cohort, ticagrelor treatment had no significant effect on the primary efficacy endpoint (myocardial infarction, stroke, or vascular death); however, in the matched cohort, ticagrelor showed a lower incidence of primary endpoint (hazard ratio: 0.56; 95% confidence interval: 0.30–1.04; p = 0.07) and stroke (hazard ratio: 0.15; 95% confidence interval: 0.02–1.24; p = 0.08) with marginal statistical significance, and a similar bleeding rate. The protective effect of ticagrelor treatment was consistent for all subgroups. More patients treated with ticagrelor experienced dyspnea (21.0% vs. 11.6%, p = 0.007), and P2Y12 antagonist treatment was consequently discontinued. Conclusion Ticagrelor treatment could provide a marginally favorable effect at the expense of an increased risk of dyspnea in real-life situations. This pilot study provides a scientific basis to call for a larger, suitably powered Phase 4 prospective or observational study in this ethnic population.

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