IPD Meta-analysis of De-escalation Treatment Strategy After PCI in ACS
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| De-escalation treatment group 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
Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention
|
| Conventional treatment group Patients diagnosed as acute coronary syndrome, and who receive conventional (non-de-escalation) antiplatelet therapy after percutaneous coronary intervention |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Individual components of the primary outcome [1 year after intervention]
cardiovascular mortality
- Individual components of the primary outcome [1 year after intervention]
non-cardiovascular mortality
- Individual components of the primary outcome [1 year after intervention]
myocardial infarction
- Individual components of the primary outcome [1 year after intervention]
stroke
- Individual components of the primary outcome [1 year after intervention]
any coronary revascularization
- Individual components of the primary outcome [1 year after intervention]
any bleeding
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
- ST. Antonius hospital Nieuwegein
- Ludwig-Maximilians - University of Munich
Investigators
- Study Director: Kyung Woo Park, MD, PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- De-escal-meta