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.
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.
Study Type
OBSERVATIONAL
Enrollment
9,000
Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention
Seoul National University Hospital
Seoul, South Korea
RECRUITINGNet adverse clinical and cerebral events (NACCE)
composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding.
Time frame: 1 year after intervention
Composite endpoint of Major adverse cardiovascular outcomes
all-cause mortality, myocardial infarction, coronary revascularization, stroke
Time frame: 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
Time frame: 1 year after intervention
Individual components of the primary outcome
all-cause mortality
Time frame: 1 year after intervention
Individual components of the primary outcome
cardiovascular mortality
Time frame: 1 year after intervention
Individual components of the primary outcome
non-cardiovascular mortality
Time frame: 1 year after intervention
Individual components of the primary outcome
myocardial infarction
Time frame: 1 year after intervention
Individual components of the primary outcome
stroke
Time frame: 1 year after intervention
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Individual components of the primary outcome
any coronary revascularization
Time frame: 1 year after intervention
Individual components of the primary outcome
any bleeding
Time frame: 1 year after intervention