PTRG-DES Consortium (PTRG)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Stent Thrombosis; Clopidogrel, Poor Metabolism of; Platelet Dysfunction
• Intervention / Treatment: Drug: Clopidogrel Tablets

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.

• Study Type: Observational
• Enrollment (Actual): 13160

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeongsangnam-do
    • Changwon, Gyeongsangnam-do, Korea, Republic of, 51472
      • Gyeongsang National University Changwon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Significant CAD patients treated with uneventful DES implantation

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTRG-DES registry; 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; DES-treated patients were treated with clopidogrel 75 mg daily and aspirin 100 mg daily; Other Names: aspirin

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical event according to gender	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to age	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to BMI	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to anemia	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to DM	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to CKD	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to disease entity (AMI vs. non-AMI)	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to LV dysfunction (LV EF)	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to complex PCI	prognostic implications of PFT, genotype and CRP	upto 10 years
Clinical event according to time point post-PCI	prognostic implications of PFT, genotype and CRP	upto 10 years

Collaborators and Investigators

• Sponsor: Gyeongsang National University Hospital
• Collaborators: Korean Society of Interventional Cardiology
• Investigators: Study Chair: Do-Sun Lim, MD, PhD, Korea University Anam Hospital, Korea University School of Medicine

Publications and helpful links

General Publications

• Kim HK, Tantry US, Smith SC Jr, Jeong MH, Park SJ, Kim MH, Lim DS, Shin ES, Park DW, Huo Y, Chen SL, Bo Z, Goto S, Kimura T, Yasuda S, Chen WJ, Chan M, Aradi D, Geisler T, Gorog DA, Sibbing D, Lip GYH, Angiolillo DJ, Gurbel PA, Jeong YH. The East Asian Paradox: An Updated Position Statement on the Challenges to the Current Antithrombotic Strategy in Patients with Cardiovascular Disease. Thromb Haemost. 2021 Apr;121(4):422-432. doi: 10.1055/s-0040-1718729. Epub 2020 Nov 10.
• Her AY, Jeong YH, Kim BK, Joo HJ, Chang K, Park Y, Song YB, Ahn SG, Suh JW, Lee SY, Cho JR, Kim HS, Kim MH, Lim DS, Shin ES; PTRG-DES Consortium Investigators. Platelet Function and Genotype after DES Implantation in East Asian Patients: Rationale and Characteristics of the PTRG-DES Consortium. Yonsei Med J. 2022 May;63(5):413-421. doi: 10.3349/ymj.2022.63.5.413.

Helpful Links

• Thrombosis and Haemostasis

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2003
• Primary Completion (ACTUAL): August 7, 2018
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (ACTUAL): February 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Genotype; Asian population; VerifyNow assay
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Disease; Coronary Artery Disease; Thrombosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: PTRG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If there are the chances of collaboration work, we will share IPD with other groups.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No