PTRG-DES Consortium

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients : A Consortium From Multi-centered Registries

Conditions
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Platelet Dysfunction, Coronary Artery Disease, Clopidogrel, Poor Metabolism of, Stent Thrombosis

Intervention / Treatment
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* Drug: Clopidogrel Tablets


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PTRG-DES registry<br>After DES implantation, CAD patients were treated with DAPT with clopidogrel and aspirin. During hospitalization, their platelet function, genotype and inflammation biomarker were evaluated. | Drug: Clopidogrel Tablets<br>* DES-treated patients were treated with clopidogrel 75 mg daily and aspirin 100 mg daily<br>* Other names: aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | All-cause death, MI, stroke or stent thrombosis | upto 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | BARC type 3-5 bleeding | upto 10 years | 
| MACE1 | CV death, MI and stent thrombosis | upto 10 years | 
| MACE2 | CV death, MI, stent thrombosis and revascularization | upto 10 years | 
| Each clinical event | all-cause death, CV death, MI, stroke, stent thrombosis, revascularization or major bleeding | upto 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asian population, VerifyNow assay, Genotype, Inflammation