IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS

Study Overview
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Brief Summary
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We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies.

Detailed Description
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This is an individual patient-level data meta-analysis (IPD Meta-analysis). This study population was incorporated from studies that were previoiusly published. We will perform a systemic review of previously published data and an updated patient-level meta-analysis of studies, including the most recent publications. PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the United States National Institutes of Health registry of clinical trials, and relevant websites were searched for pertinent published studies. The electronic search strategy was complemented by manual examination of references cited by included articles, recent reviews, editorials, and meta-analyses. No restrictions were imposed on language, study period, or sample size. The search keywords include acute coronary syndrome, ACS, primary, percutaneous coronary intervention, PCI, de-escalation, guided, guide, antiplatelet, P2Y12 inhibitor, P2Y12, dual antiplatelet therapy, DAPT. Articles were included when they met the following prespecified criteria: (1) included the ACS patients who underwent PCI with drug-eluting stent (DES); (2) maintained DAPT for 1 year; (3) de-escalation strategy of DAPT was clearly defined; (4) clinical outcomes, including ischemic and bleeding events, were clearly reported; (5) randomized controlled trials were considered for inclusion. Two independent investigators screened titles and abstracts, identified duplicated studies, performed full-article reviews, and determined the study inclusion. The third investigator supervised the searching process and adjudicated all the disagreements. After selecting eligible RCTs, we will incorporate all known randomized controlled trials requesting individual patient data from the principal investigator of each trial.

Official Title
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Comparison of De-escalation Treatment Strategy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome, Coronary Artery Disease

Intervention / Treatment
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* Drug: De-escalation Treatment Strategy of dual antiplatelet therapy


Participation Criteria
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Eligibility Criteria
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This study is a meta-analysis of previously published studies. Therefore, the eligibility criteria may be diverse according to the individual studies. -------------------------- Inclusion Criteria: Subject must have clinical diagnosis of acute coronary syndrome Exclusion Criteria: The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| De-escalation treatment group<br>Patients diagnosed as acute coronary syndrome, and who receive de-escalation antiplatelet therapy after percutaneous coronary intervention | Drug: De-escalation Treatment Strategy of dual antiplatelet therapy<br>* Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention<br>|
| Conventional treatment group<br>Patients diagnosed as acute coronary syndrome, and who receive conventional (non-de-escalation) antiplatelet therapy after percutaneous coronary intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical and cerebral events (NACCE) | composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding. | 1 year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of Major adverse cardiovascular outcomes | all-cause mortality, myocardial infarction, coronary revascularization, stroke | 1 year after intervention | 
| Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria | Bleeding outcomes, defined by the Bleeding Academic Research Consortium criteria | 1 year after intervention | 
| Individual components of the primary outcome | all-cause mortality | 1 year after intervention | 
| Individual components of the primary outcome | cardiovascular mortality | 1 year after intervention | 
| Individual components of the primary outcome | non-cardiovascular mortality | 1 year after intervention | 
| Individual components of the primary outcome | myocardial infarction | 1 year after intervention | 
| Individual components of the primary outcome | stroke | 1 year after intervention | 
| Individual components of the primary outcome | any coronary revascularization | 1 year after intervention | 
| Individual components of the primary outcome | any bleeding | 1 year after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de-escalation, percutaneous coronary intervention, dual antiplatelet therapy