Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator

NCT ID: NCT05527717

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2028-12-31

Brief Summary

This study is a prospective, open-label, two-arm, randomized multicenter trial to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with an advanced form of CS patients who require veno-arterial extracorporeal membrane oxygenator (VA-ECMO).

Detailed Description

Cardiogenic shock (CS) is a fatal complication of acute myocardial infarction (AMI). Until now, in this setting, it has been well-known that early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) was associated with improved clinical outcomes although the rate of mortality remains still high in the mechanical circulatory support (MCS) era. In real-world practice, since clinically significant non-infarct related artery (non-IRA) stenosis or occlusion in addition to an IRA can be found in 70% to 80% of patients with AMI complicated by CS, the decision of revascularization strategy is a crucial issue to improve clinical outcomes in CS patients with multivessel disease. The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) and the 2017 European Society of Cardiology (ESC) guidelines recommend considering PCI of severe stenosis in non-IRA during a primary procedure to improve overall myocardial perfusion and hemodynamic stability for patients with AMI and CS. However, the CULPRIT-SHOCK trial, which is the largest randomized trial in CS, demonstrated the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was higher in the immediate multi-vessel PCI than in the culprit lesion-only PCI group. In this regard, the recently updated guidelines do not recommend the routine non-IRA revascularization during primary PCI and it should be considered in selected cases in which there is a very severe flow-limiting non-IRA stenosis irrigating a large myocardial area. Nevertheless, there is still some unsolved issue regarding the role of non-IRA revascularization in AMI patients with CS. Majority of enrolled patients in the CULPRIT-SHOCK trial might have a mild form of CS (median systolic blood pressure of 100) and few patients received MCS devices (28.3% of study population). Furthermore, the mortality benefits of culprit-only PCI were attenuated at 1-year follow-up with an increased risk of repeat revascularization and hospitalization for heart failure. In contrast to the CULPRIT-SHOCK trial, the recent large United State registry from National Cardiovascular Data Registry demonstrated that the benefits of multi-vessel PCI in patients with non-ST-segment elevation MI and CS was more pronounced in those requiring MCS. In addition, recent data from the Korea Acute Myocardial Infarction National Health Registry showed that multivessel PCI was associated with a lower risk of all-cause death than culprit-only PCI, suggesting possible benefit of nonculprit lesion revascularization during the index hospitalization on long-term clinical outcomes.

Therefore, the current randomized trial sought to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with advanced form of CS patients who requiring veno-arterial extracorporeal membrane oxygenator (VA-ECMO).

Conditions

Cardiogenic Shock; Acute Myocardial Infarction; Multi Vessel Coronary Artery Disease; Extracorporeal Membrane Oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Culprit-lesion only PCI arm

Patients will receive culprit-lesion only PCI.

Group Type: ACTIVE_COMPARATOR

Culprit lesion only PCI

Intervention Type: PROCEDURE

Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio.

This group will be taken culprit-lesion only PCI during primary PCI.

Immediate multi-vesesl PCI arm

Patients will receive immediate multi-vessel PCI.

Group Type: EXPERIMENTAL

Immediate multi-vessel PCI

Intervention Type: PROCEDURE

Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio.

This group will be taken immediate multi-vesesl PCI during primary PCI.

Interventions

Culprit lesion only PCI

Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio.

This group will be taken culprit-lesion only PCI during primary PCI.

Intervention Type: PROCEDURE

Immediate multi-vessel PCI

Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio.

This group will be taken immediate multi-vesesl PCI during primary PCI.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subject must be at least 19 years of age
• Patients presented with AMI (ST-segment elevation MI [STEMI] or non-ST-segment elevation MI [NSTEMI]) complicated by CS (SCAI Shock classification C, D or E) who requiring VA-ECMO.
• Target lesions amenable for planned primary PCI by operators' decision
• Patients with multi-vessel disease

Exclusion Criteria

• Other causes of shock (hypovolemia, sepsis, obstructive shock).
• Shock due to mechanical complication to MI (rupture of papillary muscle, the ventricular septum, or free wall).
• Unwitnessed out of hospital cardiac arrest with persistent Glasgow coma scale <8 after the return of spontaneous circulation.
• Patients with single-vessel disease (Patients with single-vessel disease will be enrolled in the RESCUE-SHOCK registry)
• Onset of shock >24 hours.
• Known heparin intolerance.
• Other severe concomitant disease with limited life expectancy < 6 months
• Pregnancy or breast feeding
• Do not resuscitate wish

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeong Hoon Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Hoon Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jeong Hoon Yang, MD

Role: CONTACT

jhysmc@gmail.com

82-2-3410-3419

Ki Hong Choi, MD

Role: CONTACT

cardiokh@gmail.com

82-2-3410-6653

Facility Contacts

Jeong Hoon Yang, MD

Role: primary

jhysmc@gmail.com

82-2-3410-3419

Other Identifiers

RESCUE-SHOCK

Identifier Type: -

Identifier Source: org_study_id