Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention (POST PCI)

a Multi-center, Open-label, Nationwide Registry-based, Randomized, Pragmatic Trial Comparing 2 Post-PCI Management Strategies in High-risk PCI Patients With Complex Clinical and Lesion Characteristics

The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease With Myocardial Infarction
• Intervention / Treatment: Diagnostic test: No Routine stress testing; Diagnostic test: routine stress testing

• Study Type: Interventional
• Enrollment (Actual): 1700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Seongnam, Korea, Republic of
    • Bundang CHA Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Eulji General Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Suwon, Korea, Republic of
    • The Catholic University of Korea, St. Vincent'S Hospital
  • Wonju, Korea, Republic of
    • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject was > 19 years of age.
2. Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.

3. Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.

   3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).

   3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented

4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Cardiogenic shock at the index admission
2. Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
3. Pregnant and/or lactating women.
4. Concurrent medical condition with a life expectancy of less than 1 years
5. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

6 Subject was unable to provide written informed consent or participate in long-term follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Routine stress testing after PCI	Diagnostic test: No Routine stress testing; In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.
Experimental: Routine stress testing at 9~15 months after PCI	Diagnostic test: routine stress testing; In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9~15 months after the procedure according to the practice pattern of each participating center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite of major cardiovascular events	a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		2 year
Myocardial infarction		2 year
Unstable angina hospitalization		2 year
Death or myocardial infarction		2 year
Any hospitalization	cardiac cause vs. noncardiac cause	2 year
Invasive catheterization		2 year
Repeat revascularization procedure	Repeat revascularization procedure during follow-up; target vs. non-target lesion (or vessel), ischemia-driven vs. not ischemia-driven.	2 year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Publications and helpful links

General Publications

• Park DW, Kang DY, Ahn JM, Yun SC, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Yoon JH, Choi JW, Kim KS, Choi SW, Lee SN, Park SJ; POST-PCI Investigators. Routine Functional Testing or Standard Care in High-Risk Patients after PCI. N Engl J Med. 2022 Sep 8;387(10):905-915. doi: 10.1056/NEJMoa2208335. Epub 2022 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PCI; unstable angina; high risk; noninvasive stress testing
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: AMCCV2017-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No