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Duration of Clopidogrel-Based Dual Antiplatelet Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome Undergoin

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Duration of Clopidogrel-Based Dual Antiplatelet Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome Undergoin Circulation Journal ORIGINAL ARTICLE Circ J 2019; 83: 1317 – 1323 doi: 10.1253/circj.CJ-18-1283 Ischemic Heart Disease Duration of Clopidogrel-Based Dual Antiplatelet Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention ― A Real-World Observation in Taiwan From 2012 to 2015 ― Yi-Heng Li, MD, PhD; Yu-Wei Chiu, MD; Jun-Jack Cheng, MD, PhD; I-Chang Hsieh, MD; Ping-Han Lo, MD; Meng-Huan Lei, MD; Kwo-Chang Ueng, MD, PhD; Fu-Tien Chiang, MD, PhD; Shih-Hsien Sung, MD, PhD; Jen-Yuan Kuo, MD; Ching-Pei Chen, MD; Wen-Ter Lai, MD; Wen-Lieng Lee, MD, PhD; Jyh-Hong Chen, MD, PhD; Taiwan ACS STENT Registry Investigators Background: Little information is available in Asia about the real-world practice of dual antiplatelet therapy (DAPT) duration for acute coronary syndrome (ACS) and its influence on clinical outcomes. Methods and Results: The Taiwan ACS STENT Registry was a prospective, multicenter study to observe ACS patients using clopidogrel-based DAPT after percutaneous coronary intervention (PCI). The primary outcome was a composite of cardiovascular death, myocardial infarction, and stroke. Overall, 2,221 ACS patients (62 years, 83% men) were included. DAPT duration was ≤9 months in 935 (42.1%). The incidence of primary outcome was higher in patients receiving DAPT ≤9 months compared with those receiving DAPT >9 months at 1 year (3.5% vs. 1.6%, P=0.0026). The incidence of stent thrombosis (overall 0.5%) was similar between groups. Multivariable analysis showed that DAPT >9 months was associated with a significantly lower risk of primary out- come (odds ratio 0.725, 95% confidence interval 0.545–0.965). Conclusions: Our data showed that short duration of DAPT (≤9 months) was common (42.1%) in Taiwan for ACS patients under- going PCI. DAPT ≤9 months increased the risk of the primary outcome. Key Words: Acute coronary syndrome; Dual antiplatelet therapy; Taiwan ual antiplatelet therapy (DAPT) with aspirin and Recurrent Events) study and another 2 clinical trials of new- P2Y12 inhibitor is the standard treatment for patients generation P2Y12 inhibitors.5–7 The optimal duration of D with acute coronary syndrome (ACS) undergoing DAPT involves an assessment of the trade-off between isch- percutaneous coronary intervention (PCI). Current American emia and bleeding. Multiple lines of evidence suggest that and European guidelines all recommend DAPT for at least 12 East Asian patients have a higher bleeding risk than white months for ACS patients regardless of the stent used in PCI.1,2 patients when receiving antiplatelet treatment.8,9 In Taiwan, In Asia, guidelines or consensus from Taiwan and Japan also bare metal stents (BMS) are still commonly used because the suggest 12-month DAPT after acute myocardial infarction National Health Insurance only reimburses the price of BMS (MI).3,4 The current suggestion of 12-month DAPT after ACS and patients have to pay at least US$1,500–2,000 for each was arbitrarily determined based on the duration of follow-up drug-eluting stent (DES). The Taiwan National Health Insurance in the CURE (Clopidogrel in Unstable angina to prevent also reimburses only 9-month DAPT for ACS patients under- Received December 4, 2018; revised manuscript received February 12, 2019; accepted March 12, 2019; J-STAGE Advance Publication released online April 27, 2019 Time for primary review: 21 days National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan (Y.-H.L.); Department of Computer Science and Engineering, Yuan Ze University, Far Eastern Memorial Hospital, New Taipei City (Y.-W.C.); Shin Kong Wu Ho-Su Memorial Hospital, Taipei (J.-J.C.); Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan (I.-C.H.); China Medical University Hospital and College of Medicine, Taichung (P.-H.L.); Lotung Poh-Ai Hospital, Lotung (M.-H.L.); Chung Shan Medical University Hospital, Taichung (K.-C.U.); National Taiwan University Hospital and Fu-Jen Catholic University Hospital, Taipei (F.-T.C.); Taipei Veterans General Hospital and National Yang Ming University, Taipei (S.-H.S.); Mackay Memorial Hospital, Taipei (J.-Y.K.); Changhua Christian Hospital, Changhua (C.-P.C.); Kaohsiung Medical University Hospital, Kaohsiung City (W.-T.L.); Taichung Veterans General Hospital, Taichung (W.-L.L.); and College of Medicine, China Medical University, Taichung (J.-H.C.), Taiwan Mailing address: Jyh-Hong Chen, MD, PhD, College of Medicine, China Medical University, No. 91 Hsueh-Shih Road, Taichung 40402, Taiwan. E-mail: [email protected] ISSN-1346-9843 All rights are reserved to the Japanese Circulation Society. For permissions, please e-mail: [email protected] Circulation Journal Vol.83, June 2019 1318 LI YH et al. from the study. The clinical data, including age, sex, vascular risk factors, previous disease history, clinical presentation, laboratory data, medications, and procedures used during the index admission, were collected prospectively according to a predetermined protocol. Follow-up The patients were followed up regularly and clinical data were collected at discharge and at 1, 3, 6, 9, and 12 months after discharge. The use of DAPT and the timing of dis- continuation were recorded during each follow-up visit. The reasons for discontinuation were answered by the in- charge cardiologists and were related to adverse events, insurance regulations, doctor’s decision, preparation for invasive procedure or surgery, need for anticoagulation, or other unidentified cause. The patients were stratified according to DAPT duration (≤9 months vs. >9 months), and baseline characteristics, treatment variables, and pri- mary outcome events were compared. The primary out- come was a composite endpoint of cardiovascular (CV) death, stroke, and MI at 12-month follow-up. The second- Figure 1. Study population flowchart. ACS, acute coronary ary outcome was the individual incidence of CV death, syndrome; DAPT, dual antiplatelet therapy; PCI, percutane- stroke, MI, stent thrombosis, and bleeding events. A bleed- ous coronary intervention. ing event was defined as any spontaneous bleeding episode that was considered clinically significant by the in-charge physicians and reported as an adverse event during the follow-up. going PCI. These considerations and insurance regulations may influence physicians’ determination of DAPT duration Statistical Analysis and potentially cause deviation from guideline recommenda- Continuous and categorical variables are presented as tions. Most of the real-world data about DAPT duration come mean ± standard deviation or number (percentage). from Western countries, showing that 12-month DAPT is used Comparisons between DAPT groups were performed by in most patients with ACS and prolonged use of DAPT unpaired t test for continuous variables and chi-square test beyond 12 months is common.10–12 Information is scarce in for categorical variables. A multivariable logistic regres- Asia about contemporary real-world practice patterns of sion analysis was performed to identify independent pre- DAPT duration and the effect on clinical outcomes following dicting factors of DAPT duration ≤9 months. The odds PCI for ACS. ratios (ORs) and associated 95% confidence intervals (CIs) In the present prospective cohort study, we used an ACS were calculated. Kaplan-Meier curves were used to evalu- registry data in Taiwan to examine real-world practice pat- ate the time to primary outcome events and the log-rank terns, patient characteristics, and clinical outcomes following test was applied to compare the differences between groups PCI for ACS in relation to DAPT duration. of DAPT duration. To further assess the effect of DAPT duration on clinical outcome, propensity score adjustment Methods was performed using logistic regression models with the following covariates: age, oral anticoagulant, cardiac Study Participants arrest, prior MI, prior PCI, heart failure, transient isch- This study was a nationwide ACS registry performed from emic attack/stroke, atrial fibrillation, prior coronary artery April 2012 to December 2015 in Taiwan by the Taiwan Society bypass grafting, hypertension, diabetes, hyperlipidemia of Cardiology.13 Adult patients (age ≥20 years) admitted and clinical presentation. Marginal mean weighting because of ACS, including ST-segment elevation MI through stratification (MMWS) was adopted to perform (STEMI), non-STEMI (NSTEMI) and unstable angina, were the propensity score analysis. All propensity scores were enrolled consecutively from 24 major hospitals across Taiwan. estimated by multinomial logistic regression, with 4 pro- The diagnosis was based on clinical symptoms, ECG and pensity scores for each patient. The MMWS computed cardiac markers changes, and further confirmed by the in- weights on the basis of stratified propensity scores and charge cardiologists. In this registry, only patients undergoing equated the pretreatment composition of different groups PCI with stent placement during admission, treated with under the assumption that unmeasured covariates did not DAPT, and surviving to discharge were included. Because the confound the treatment effects. We stratified propensity 1st-generation DES were no longer used after 2012 in Taiwan, score into 5 quintiles per stratum in each DAPT duration all patients received 2nd- or newer generation DES and/or group, followed by the MMWS calculation in each stratum BMS. Because clopidogrel was the most commonly used and DAPT duration group. Data balance was
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