Clinical trial NCT05527717: Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiogenic Shock
Acute Myocardial Infarction
Multi Vessel Coronary Artery Disease
Extracorporeal Membrane Oxygenation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 560
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open-label, two-arm, randomized controlled trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy
timeFrame: 90 days after primary PCI
Secondary outcomes:
measure: Rates of In-hospital mortality
timeFrame: Up to 30 days
measure: Rates of In-hospital cardiac mortality
timeFrame: Up to 30 days
measure: Rates of VA-ECMO weaning success
timeFrame: Up to 30 days
measure: Time to VA-ECMO weaning
timeFrame: Up to 30 days
measure: Rates of critical limb ischemia after successful VA-ECMO weaning
timeFrame: Up to 30 days
measure: Cerebral Performance Category (CPC) 3-5 at discharge
timeFrame: Up to 30 days
measure: Length of intensive-care unit (ICU) stay
timeFrame: Up to 30 days
measure: Total procedural time
timeFrame: Immediate after the index procedure
measure: Total amount of contrast use
timeFrame: Immediate after the index procedure
measure: Rates of all-cause mortality
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of cardiac mortality
timeFrame: 90 Days and 12 months after primary PCI
measure: Requirement of cardiac replacement therapy
timeFrame: 90 Days and 12 months after primary PCI
measure: Requirement of renal replacement therapy
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of myocardial infarction (MI)
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of MI related to culprit vessel
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of MI related to non-culprit vessel
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of stent thrombosis
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of Re-hospitalization due to heart failure
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of Re-hospitalization due to any cause
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of target-lesion revascularization (TLR)
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of target-vessel revascularization (TVR)
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of repeat revascularization
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of cerebrovascular accident
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of bleeding
timeFrame: 90 Days and 12 months after primary PCI
measure: Rates of major bleeding
timeFrame: 90 Days and 12 months after primary PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong Hoon Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: