Acute Coronary Syndrome, Drug-Eluting Stents, Percutaneous Coronary Intervention
Conditions
Keywords
Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug-Eluting Stents, Platelet Aggregation Inhibitors, Ticagrelor, clopidogrel, Purinergic P2Y Receptor Antagonists
Brief summary
Acute coronary syndrome (ACS) guidelines have been changed, favoring dual antiplatelet therapy (DAPT) with the more potent P2Y12 inhibitor ticagrelor over clopidogrel (besides aspirin). This change is based on studies that showed benefits of ticagrelor. However, study participants were only partly treated by percutaneous coronary intervention (PCI). In patients who were treated by PCI, this was generally performed using of bare metal or first-generation drug-eluting stents (DES). CHANGE DAPT is an investigator-initiated, prospective, single centre registry, in which we evaluate the impact of the guideline suggested change in the primary DAPT regimen (from clopidogrel to ticagrelor) on 1-year clinical outcome in ACS patients treated by PCI with newer-generation DES in the Thoraxcentrum Twente.
Interventions
DRUGClopidogrel
DRUGTicagrelor
Sponsors
Thorax Centrum Twente
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Presentation with acute coronary syndrome (ACS) * Treated with newer-generation drug-eluting stent (DES) in coronary artery or bypass graft lesion
Exclusion criteria
* Known pregnancy * Life expectancy less than one year * Planned elective surgery requiring interruption of DAPT in the first 6 months * Known intolerance to components of the DES available * Indication for oral anticoagulation at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical and cerebral events (NACCE) | 1 year | A composite of all-cause death, any myocardial infarction, stroke, or major bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any myocardial infarction | 1 year | According to the Academic Research Consortium (ARC) definition |
| All-cause death | 1 year | All-cause mortality |
| Stroke | 1 year | Focal loss of neurologic function caused by an ischemic or hemorrhagic event with residual symptoms lasting at least 24 hours or leading to death |
| Major Bleeding | 1 year | Defined by Thrombolysis in Myocardial Infarction (TIMI) major bleeding or TIMI in the setting of coronary artery bypass grafting, and/or any Bleeding Academic Research Consortium (BARC) class 3 or 5. |
| Any clinically indicated revascularization | 1 year | Revascularization by PCI or CABG |
| Stent thrombosis | 1 year | According to the Academic Research Consortium (ARC) definition |
Countries
Netherlands
Outcome results
None listed