Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
- Conditions
- Multi Vessel Coronary Artery DiseaseCardiogenic ShockExtracorporeal Membrane OxygenationAcute Myocardial Infarction
- Interventions
- Procedure: Immediate multi-vessel PCIProcedure: Culprit lesion only PCI
- Registration Number
- NCT05527717
- Lead Sponsor
- Samsung Medical Center
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 560
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate multi-vesesl PCI arm Immediate multi-vessel PCI Patients will receive immediate multi-vessel PCI. Culprit-lesion only PCI arm Culprit lesion only PCI Patients will receive culprit-lesion only PCI.
- Primary Outcome Measures
Name Time Method Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy 90 days after primary PCI all-cause mortality or requiring left ventricular assisted device (LVAD) insertion or heart transplantation)
- Secondary Outcome Measures
Name Time Method Rates of In-hospital mortality Up to 30 days Death by any cause in hospital
Rates of In-hospital cardiac mortality Up to 30 days Death by cardiac cause in hospital
Rates of target-lesion revascularization (TLR) 90 Days and 12 months after primary PCI TLR during follow-up
Rates of VA-ECMO weaning success Up to 30 days 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.
Rates of critical limb ischemia after successful VA-ECMO weaning Up to 30 days 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)
Rates of myocardial infarction (MI) 90 Days and 12 months after primary PCI spontaneous MI during follow-up
Rates of Re-hospitalization due to any cause 90 Days and 12 months after primary PCI Re-hospitalization due to any cause during follow-up
Rates of all-cause mortality 90 Days and 12 months after primary PCI Death by any cause
Rates of MI related to non-culprit vessel 90 Days and 12 months after primary PCI MI related to non-culprit vessel during follow-up
Rates of major bleeding 90 Days and 12 months after primary PCI (BARC type 3 or 5
Length of intensive-care unit (ICU) stay Up to 30 days ICU stay day
Total procedural time Immediate after the index procedure Procedural time (minutes)
Rates of cardiac mortality 90 Days and 12 months after primary PCI Death by cardiac cause
Requirement of renal replacement therapy 90 Days and 12 months after primary PCI Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
Rates of MI related to culprit vessel 90 Days and 12 months after primary PCI MI related to culprit vessel during follow-up
Time to VA-ECMO weaning Up to 30 days Time from VA-ECMO insertion to VA-ECMO weaning
Cerebral Performance Category (CPC) 3-5 at discharge Up to 30 days Neurologic performance scale at discharge
Total amount of contrast use Immediate after the index procedure Contrast use (cc)
Requirement of cardiac replacement therapy 90 Days and 12 months after primary PCI LVAD insertion or heart transplantation
Rates of stent thrombosis 90 Days and 12 months after primary PCI Academic Research Consortium (ARC)-defined definite or probable stent thrombosis
Rates of Re-hospitalization due to heart failure 90 Days and 12 months after primary PCI Re-hospitalization due to heart failure during follow-up
Rates of target-vessel revascularization (TVR) 90 Days and 12 months after primary PCI TVR during follow-up
Rates of repeat revascularization 90 Days and 12 months after primary PCI Repeat revascularization during follow-up
Rates of cerebrovascular accident 90 Days and 12 months after primary PCI Cerebrovascular accident during follow-up
Rates of bleeding 90 Days and 12 months after primary PCI Bleeding ARC \[BARC\] type 2, 3, or 5
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of