scholarly journals Effects of Evolocumab Added to Moderate-Intensity Statin Therapy in Chinese Patients With Acute Coronary Syndrome: The EMSIACS Trial Study Protocol

2021 ◽  
Vol 12 ◽  
Author(s):  
Jing Gao ◽  
Jing-Yu Liu ◽  
Peng-Ju Lu ◽  
Jian-Yong Xiao ◽  
Ming-Dong Gao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Statin Therapy ◽  
Acute Phase ◽  
Primary Outcome ◽  
Sample Size Calculation ◽  
Chinese Patients ◽  
Moderate Intensity ◽  
Secondary Outcome ◽  
Coronary Syndrome

Background: Several studies have demonstrated that using a higher dose of statin can easily induce liver injury and myopathy. Low-density lipoprotein cholesterol (LDL-C) is a well-established modifiable risk factor for cardiovascular disease; however, the large majority of Chinese patients cannot meet the target level of LDL-C recommended by the Chinese expert consensus. Evolocumab has been demonstrated to reduce LDL-C by approximately 60% in many studies. Nevertheless, whether combined evolocumab and moderate-intensity statin is as effective in lowering LDL-C and decreasing incidence of MACE in Chinese patients presenting with the acute phase of acute coronary syndrome (ACS) remains unknown. Therefore, the “Evolocumab added to Moderate-Intensity Statin therapy on LDL-C lowering and cardiovascular adverse events in patients with Acute Coronary Syndrome” (EMSIACS) is conducted.Methods: The EMSIACS is a prospective, randomized, open-label, parallel-group, multicenter study involving analyzing the feasibility and efficacy of evolocumab added to moderate-intensity statin therapy on lowering LDL-C levels in adult Chinese patients hospitalized for acute phase ACS. The sample size calculation is based on the primary outcome, and 500 patients will be planned to recruit. Patients are randomized in evolocumab arm (evolocumab 140mg every 2weeks plus rosuvastatin 10mg/day or atorvastatin 20mg/day) and statin-only arm (rosuvastatin 10mg/day or atorvastatin 20mg/day). The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12weeks and 1year of treatment.Discussion: If the EMSIACS trial endpoints prove statistically significant, the evolocumab added to moderate-intensity statin therapy will have the potential to effectively lower subjects’ LDL-C levels, especially for the Chinese patients with acute phase ACS. However, if the risk of MACE is not significantly different between the two groups, we may extend follow-up time for secondary outcome when the clinical trial is over.Clinical trial registration: The study is registered to ClinicalTrials.gov (NCT04100434), which retrospectively registered on November 24, 2020.

scholarly journals Descriptive analysis of real-world medication use pattern of statins and antiplatelet agents among patients with acute coronary syndrome in Hong Kong and the USA

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e024937
Author(s):  
Yun Wang ◽  
Michael B Nichol ◽  
Bryan PY Yan ◽  
Joanne Wu ◽  
Brian Tomlinson ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Hong Kong ◽  
Medication Use ◽  
Antiplatelet Agents ◽  
Chinese Patients ◽  
Lipid Lowering ◽  
Secondary Outcome ◽  
Coronary Syndrome ◽  
The Usa ◽  
Use Pattern

ObjectivesThe objective was to explore the differences in medication use pattern of lipid-lowering drug (LLD) and antiplatelet agents among post-percutaneous coronary intervention patients with acute coronary syndrome aged <65 in Hong Kong (HK) and the USA.DesignRetrospective study.SettingThis study used deidentified claims data from Clinformatics Data Mart database (OptumInsight, Eden Prairie, Minnesota, USA) and electronic health records from HK Hospital Authority Clinical Data Analysis and Reporting System database.ParticipantsWe used 1 year prescription records of LLDs and antiplatelet agents among 1013 USA patients and 270 HK Chinese patients in 2011–2013.Primary and secondary outcome measuresContinuity was investigated on the assumption that one defined daily dose represented 1 day treatment. Medication possession ratio method was used to evaluate the adherence. Multivariate-adjusted logistic regressions were constructed to compare the good continuity and adherence levels in the merged database with the cutoffs set at 80%, and Cox proportional hazard models were built using the time to discontinuation as the dependent variable, to assess the persistence level.ResultsHK Chinese patients were less adherent (67.41% vs 84.60%, adjusted odds ratio (AOR) for Americans over Chinese=2.23 (95% CI=1.60 to 3.12), p<0.001) to antiplatelet agents compared with American patients but better adherent to statins (90.00% vs 78.18%, AOR=0.37 (0.23 to 0.58), p<0.001). The discontinuation with statins was more common in American patients (13.33% vs 34.25%, adjusted hazard ratio (AHR)=2.95 (2.05 to 4.24), p<0.001). Low-to-moderate potency statins and clopidogrel were favoured by our HK local physicians, while American patients received higher doses of statins and prasugrel.ConclusionsWe seemed to find HK physicians tended to prescribe cheaper and lower doses of statins and antiplatelet agents when compared with the privately insured patients in the USA, though the adherence and persistence levels of HK patients with statins were relatively good.

Ticagrelor-based antiplatelet regimens in patients treated with coronary artery bypass grafting: a meta-analysis of randomized controlled trials

2019 ◽  
Author(s):  
Moritz von Scheidt ◽  
Dario Bongiovanni ◽  
Ulrich Tebbe ◽  
Bernd Nowak ◽  
Jan Stritzke ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Outcomes ◽  
Cardiac Death ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Major Adverse Cardiac Events ◽  
Secondary Outcome ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Adverse Cardiac Events

Abstract OBJECTIVES The optimal antiplatelet strategy in patients undergoing CABG remains unclear. This is the first meta-analysis investigating the clinical outcomes associated with ticagrelor-based antiplatelet regimens in patients receiving CABG. METHODS Relevant scientific databases were searched for studies investigating antiplatelet regimens after CABG from inception until April 1, 2019. Studies which randomly assigned CABG patients to either ticagrelor-based or control antiplatelet regimens were eligible. The primary outcome of this analysis was all-cause death. The main secondary outcome was MI. Other outcomes of interest were cardiac death, major adverse cardiac events, stroke and bleeding. This study is registered with PROSPERO, number CRD42019122192. RESULTS Five trials comprising 3996 patients (2002 assigned to ticagrelor-based and 1994 to control antiplatelet regimens) were eligible for quantitative synthesis. The median follow-up was 12 months. Control antiplatelet regimens consisted of either aspirin or clopidogrel or both. As compared to control, ticagrelor-based regimens reduced the risk of all-cause death [0.61 (0.43–0.87); P = 0.007], cardiac death [0.58 (0.39–0.86); P = 0.007] and major adverse cardiac events [0.79 (0.63–0.98); P = 0.03], without difference in the risk of MI [0.76 (0.50–1.18); P = 0.22], stroke [0.99 (0.56–1.78); P = 0.98] or bleeding [1.04 (0.95–1.14); P = 0.41]. There was a treatment effect modification for the primary outcome associated with trials enrolling predominantly patients with acute coronary syndrome (P for interaction = 0.038). CONCLUSIONS In patients receiving CABG, ticagrelor-based regimens reduce mortality and major adverse cardiac events without excess bleeding risk as compared with aspirin monotherapy or the combination of aspirin and clopidogrel. The benefit of ticagrelor-based regimens is more relevant in those studies enrolling predominantly patients with acute coronary syndrome. These findings require further confirmation in randomized trials focused on this subset of patients and powered for clinical outcomes.

scholarly journals Higher baseline lipid levels amplify the benefit of secondary prevention therapy with statins in Chinese patients with acute coronary syndrome

2020 ◽  
Vol 48 (11) ◽  
pp. 030006052096584
Author(s):  
Ling Zhu ◽  
Ying Liu ◽  
Wei Zhang ◽  
Zhu Zhang ◽  
Liqin Zhou ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Statin Therapy ◽  
Lower Risk ◽  
Chinese Patients ◽  
Lipid Levels ◽  
Coronary Syndrome ◽  
Group 4 ◽  
Group 3 ◽  
Statin Use ◽  
Group 1

Objective Statins are recommended as the first-line treatments for reducing the risk of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS). The present study aimed to establish the baseline lipid levels associated with the greatest benefit from statin therapy in this population. Methods The study used a retrospective cohort methodology. In total, 636 patients with ACS were enrolled at Shaanxi Provincial People’s Hospital from 2011 to 2013. Participants were divided into four groups (group 1, hyperlipidemia with inconsistent statin use; group 2, no hyperlipidemia with inconsistent statin use; group 3, no hyperlipidemia with consistent statin use; and group 4, hyperlipidemia with consistent statin use). Results Patients in groups 3 (hazard ratio [HR] = 0.49, 95% confidence interval [CI] = 0.29–0.82) and 4 (HR = 0.21, 95% CI = 0.10–0.45) had lower risks of MACE than those in group 1. In subgroup analysis, patients in group 4 had a lower risk of MACE than those in group 3 (adjusted HR = 0.43, 95% CI = 0.21–0.89). Conclusion Sustained statin therapy is associated with a lower risk of adverse outcomes in patients with ACS, especially in those with higher baseline lipid levels.

scholarly journals Impact of timing of randomization after an acute coronary syndrome and subsequent events in patients with type 2 diabetes mellitus: an analysis of the EXAMINE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Elharram ◽  
A Sharma ◽  
W White ◽  
G Bakris ◽  
P Rossignol ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Primary Outcome ◽  
Funding Source ◽  
Coronary Syndrome ◽  
The Impact

Abstract Background The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes. Methods EXAMINE was a randomized trial of alogliptin versus placebo in 5380 patients with T2DM and a recent ACS. The primary outcome was a composite of CV death, non-fatal myocardial infarction [MI], or non-fatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8–34, 35–56, and 57–141 days. Results Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs. 33.0%), prior coronary artery bypass graft (9.6% vs. 15.9%), or atrial fibrillation (5.9% vs. 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio [aHR] 1.47; 95% CI 1.21–1.74) (Figure 1). Similarly, patients randomized early had an increased risk of recurrent MI (aHR 1.51; 95% CI 1.17–1.96) and HF hospitalization (1.49; 95% CI 1.05–2.10). Conclusion In a contemporary cohort of T2DM with a recent ACS, early randomization following the ACS increases the risk of CV events including recurrent MI and HF hospitalization. This should be taken into account when designing future clinical trials. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Takeda Pharmaceutical

scholarly journals Benefit and Harm of Extended Dual Antiplatelet Therapy After PCI in high-risk TWILIGHT-like patients with acute coronary syndrome

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
HY Wang ◽  
R Zhang ◽  
ZX Cai ◽  
KF Dou
Keyword(s):  
Acute Coronary Syndrome ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Cardiovascular Death ◽  
Secondary Outcome ◽  
Short Term ◽  
Bleeding Events ◽  
Coronary Syndrome

Abstract Funding Acknowledgements Type of funding sources: None. Background Recent emphasis on reduced duration and/or intensity of antiplatelet therapy following PCI irrespective of indication for PCI may fail to account for the substantial risk of subsequent nontarget lesion events in acute coronary syndrome (ACS) patients. This study sought to investigate the benefits and risks of extended-term (&gt;12-month) DAPT as compared with short-term DAPT in high-risk "TWILIGHT-like" ACS patients undergoing PCI. Methods All consecutive patients fulfilling the "TWILIGHT-like" criteria undergoing PCI from January 2013 to December 2013 were identified from the prospective Fuwai PCI Registry. High-risk "TWILIGHT-like" patients were defined by at least 1 clinical and 1 angiographic feature based on TWILIGHT trial selection criteria. The present analysis evaluated 4,875 high-risk "TWILIGHT-like" patients with ACS who were event-free at 12 months after PCI. The primary outcome was the composite of all-cause death, myocardial infarction (MI), or stroke at 30 months while BARC type 2, 3, or 5 bleeding was key secondary outcome. Results Extended DAPT compared with shorter DAPT reduced the composite outcome of all-cause death, MI, or stroke by 63% (1.5% vs. 3.8%; HRadj: 0.374, 95% CI: 0.256 to 0.548; HRmatched: 0.361, 95% CI: 0.221-0.590). The HR for cardiovascular death was 0.049 (0.007 to 0.362) and that for MI 0.45 (0.153 to 1.320) and definite/probable stent thrombosis 0.296 (0.080-1.095) in propensity-matched analyses. Rates of BARC type 2, 3, or 5 bleeding (0.9% vs. 1.3%; HRadj: 0.668 [0.379 to 1.178]; HRmatched: 0.721 [0.369-1.410]) did not differ significantly in patients treated with DAPT &gt; 12-month or DAPT ≤ 12-month. The effect of long-term DAPT on primary and key secondary outcome across the proportion of ACS patients with 1-3, 4-5, or 6-9 risk factors showed a consistent manner (Pinteraction &gt; 0.05). Conclusion Among high-risk "TWILIGHT-like" patients with ACS after PCI, long-term DAPT reduced ischemic events without increasing clinically meaningful bleeding events as compared with short-term DAPT, suggesting that extended DAPT might be considered in the treatment of ACS patients who present with a particularly higher risk for thrombotic complications. Abstract Figure.

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