Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention, dual antiplatelet therapy, de-escalation
Brief summary
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
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.
Interventions
DRUGDe-escalation Treatment Strategy of dual antiplatelet therapy
Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention
Sponsors
St. Antonius Hospital
Ludwig-Maximilians - University of Munich
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical and cerebral events (NACCE) | 1 year after intervention | composite of all-cause death, myocardial infarction, coronary revascularization, stroke and major bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of Major adverse cardiovascular outcomes | 1 year after intervention | all-cause mortality, myocardial infarction, coronary revascularization, stroke |
| Major Bleeding outcome defined by the Bleeding Academic Research Consortium (BARC) criteria | 1 year after intervention | Bleeding outcomes, defined by the Bleeding Academic Research Consortium criteria |
| Individual components of the primary outcome | 1 year after intervention | all-cause mortality |
Countries
South Korea
Contacts
Primary ContactHyo-Soo Kim, MD, PhD
Backup ContactJeehoon Kang, MD
Outcome results
None listed