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
N1 - Funding Information:
This work was supported, in part, by the Tainan Municipal Hospital Research Grant ( RA14005 ), the Multidisciplinary Center of Excellence for Clinical Trial and Research (grant number DOH 102-TD-B-111-002 ) from the Department of Health, Executive Yuan, Taiwan ; a Landmark Project to Promote Innovation and Competitiveness of Clinical Trials by the Excellent Clinical Trial and Research Center in National Cheng Kung University Hospital from the Ministry of Health and Welfare, Taiwan ( MOHW103-TDU-B-211-113002 and MOHW104-TDU-B-211-113002 ); and the Ministry of Science and Technology, Taiwan (grant number MOST 104-2314-B-006-085 ). The funding organizations did not have a role in the design, conduct, or analysis of this study.
Publisher Copyright:
© 2016
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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U2 - 10.1016/j.jcma.2016.02.010
DO - 10.1016/j.jcma.2016.02.010
M3 - Article
C2 - 27339180
AN - SCOPUS:84996995549
VL - 79
SP - 521
EP - 530
JO - Journal of the Chinese Medical Association
JF - Journal of the Chinese Medical Association
SN - 1726-4901
IS - 10
ER -