Revascularization Strategy of Multivessel Disease for Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator (RESCUE-SHOCK)

REvaSCUlarization StratEgy of Multivessel Coronary Artery Disease for Patients With Acute Myocardial Infarction Complicated by Cardiogenic SHOCK Undergoing Veno-arterial Extracorporeal Membrane Oxygenator: Randomized-Controlled Trial (RESCUE-SHOCK)

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).

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Acute Myocardial Infarction; Cardiogenic Shock; Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Procedure: Culprit lesion only PCI; Procedure: Immediate multi-vessel PCI

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).

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ki Hong Choi, MD; Phone Number: 82-2-3410-6653; Email: cardiokh@gmail.com
• Study Contact Backup: Name: Jeong Hoon Yang, MD; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Jeong Hoon Yang, MD; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Culprit-lesion only PCI arm; Patients will receive culprit-lesion only PCI.	Procedure: 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.
Experimental: Immediate multi-vesesl PCI arm; Patients will receive immediate multi-vessel PCI.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy	all-cause mortality or requiring left ventricular assisted device (LVAD) insertion or heart transplantation)	90 days after primary PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of In-hospital mortality	Death by any cause in hospital	Up to 30 days
Rates of In-hospital cardiac mortality	Death by cardiac cause in hospital	Up to 30 days
Rates of VA-ECMO weaning success	Successful weaning of VA-ECMO was defined as successful removal of VA-ECMO and not requiring further mechanical support because of recurring cardiogenic shock over the following 48 hours.	Up to 30 days
Time to VA-ECMO weaning	Time from VA-ECMO insertion to VA-ECMO weaning	Up to 30 days
Rates of critical limb ischemia after successful VA-ECMO weaning	Critical limb ischemia is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. (Rutherford classification 4, 5, or 6)	Up to 30 days
Cerebral Performance Category (CPC) 3-5 at discharge	Neurologic performance scale at discharge	Up to 30 days
Length of intensive-care unit (ICU) stay	ICU stay day	Up to 30 days
Total procedural time	Procedural time (minutes)	Immediate after the index procedure
Total amount of contrast use	Contrast use (cc)	Immediate after the index procedure
Rates of all-cause mortality	Death by any cause	90 Days and 12 months after primary PCI
Rates of cardiac mortality	Death by cardiac cause	90 Days and 12 months after primary PCI
Requirement of cardiac replacement therapy	LVAD insertion or heart transplantation	90 Days and 12 months after primary PCI
Requirement of renal replacement therapy	Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis	90 Days and 12 months after primary PCI
Rates of myocardial infarction (MI)	spontaneous MI during follow-up	90 Days and 12 months after primary PCI
Rates of MI related to culprit vessel	MI related to culprit vessel during follow-up	90 Days and 12 months after primary PCI
Rates of MI related to non-culprit vessel	MI related to non-culprit vessel during follow-up	90 Days and 12 months after primary PCI
Rates of stent thrombosis	Academic Research Consortium (ARC)-defined definite or probable stent thrombosis	90 Days and 12 months after primary PCI
Rates of Re-hospitalization due to heart failure	Re-hospitalization due to heart failure during follow-up	90 Days and 12 months after primary PCI
Rates of Re-hospitalization due to any cause	Re-hospitalization due to any cause during follow-up	90 Days and 12 months after primary PCI
Rates of target-lesion revascularization (TLR)	TLR during follow-up	90 Days and 12 months after primary PCI
Rates of target-vessel revascularization (TVR)	TVR during follow-up	90 Days and 12 months after primary PCI
Rates of repeat revascularization	Repeat revascularization during follow-up	90 Days and 12 months after primary PCI
Rates of cerebrovascular accident	Cerebrovascular accident during follow-up	90 Days and 12 months after primary PCI
Rates of bleeding	Bleeding ARC [BARC] type 2, 3, or 5	90 Days and 12 months after primary PCI
Rates of major bleeding	(BARC type 3 or 5	90 Days and 12 months after primary PCI

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jeong Hoon Yang, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: August 27, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Shock; Shock, Cardiogenic
• Other Study ID Numbers: RESCUE-SHOCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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