Clopidogrel, Poor Metabolism of, Coronary Artery Disease, Platelet Dysfunction, Stent Thrombosis
Conditions
Keywords
Asian population, VerifyNow assay, Genotype, Inflammation
Brief summary
The PTRG-DES consortium is a coalition composed of multi-center, real-world registries including CAD patients treated with DES in South Korea. From 9 academic registries in Korea, a total of 13,160 patients were enrolled for this database between July 2003 and August 2018. The aim of the study was to investigate long-term prognostic implications of platelet function and genotypes after DES implantation for significant CAD in South Korea.
Detailed description
The investigators enrolled patients treated with DES during DAPT including clopidogrel who had at least one of VerifyNow test (PRU and ARU) and genotyping. In this consortium, the investigators tried to find the unique characteristics of East Asians based on platelet function, genotype and inflammatory markers.
Interventions
DES-treated patients were treated with clopidogrel 75 mg daily and aspirin 100 mg daily
Sponsors
Korean Society of Interventional Cardiology
Gyeongsang National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients at every centre successfully treated with one or more DES approved by the US FDA or CE mark and who were adequately loaded with clopidogrel were eligible for enrolment, regardless of patient or lesion complexity.
Exclusion criteria
* the occurrence of a major complication during the procedure or before platelet function testing, or if bypass surgery was planned after PCI. * Any P2Y12 inhibitor other than clopidogrel * PCI strategy other than DES * Needed oral anticoagulant (e.g. atrial fibrillation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | upto 10 years | All-cause death, MI, stroke or stent thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding | upto 10 years | BARC type 3-5 bleeding |
| MACE1 | upto 10 years | CV death, MI and stent thrombosis |
| MACE2 | upto 10 years | CV death, MI, stent thrombosis and revascularization |
| Each clinical event | upto 10 years | all-cause death, CV death, MI, stroke, stent thrombosis, revascularization or major bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical event according to CKD | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to disease entity (AMI vs. non-AMI) | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to gender | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to complex PCI | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to time point post-PCI | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to LV dysfunction (LV EF) | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to age | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to BMI | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to anemia | upto 10 years | prognostic implications of PFT, genotype and CRP |
| Clinical event according to DM | upto 10 years | prognostic implications of PFT, genotype and CRP |
Countries
South Korea
Outcome results
None listed