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

Not Applicable

Completed

• Conditions: Coronary Artery Disease With Myocardial Infarction
• Interventions: Diagnostic Test: No Routine stress testing; Diagnostic Test: routine stress testing

• Registration Number: NCT03217877
• Lead Sponsor: Seung-Jung Park

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-14
• Study Start: 2017-11-15
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Routine stress testing after PCI	No Routine stress testing	-
Routine stress testing at 9~15 months after PCI	routine stress testing	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Bundang CHA Hospital; 🇰🇷 Seongnam, Korea, Republic of

Eulji General Hospital; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of

Seoul National University Bundang hospital; 🇰🇷 Seongnam, Korea, Republic of

The Catholic University of Korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic university of Korea, ST. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of