ECMO, High-risk PCI
Conditions
Keywords
ECMO, PCI
Brief summary
The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is : • If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI
Detailed description
Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy.
Interventions
PROCEDUREStandby cannulated ECMO
Femoral cannulas are inserted and connected to the primed circuit. Clamps are kept on circuit, and ECMO is on standby during PCI. ECMO is initiated if needed.
PROCEDUREProphylactic ECMO
Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.
Sponsors
Beijing Anzhen Hospital
Wuhan Asia Heart Hospital
First Affiliated Hospital of Harbin Medical University
People's Hospital of Xinjiang Uygur Autonomous Region
People's Hospital of Guangxi Zhuang Autonomous Region
The First Affiliated Hospital of Lanzhou Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
The Second Affiliated Hospital of Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinicians decide to perform PCI during ECMO support. 2. Age of ≥18 3. Patient presents with a compromised ejection fraction of less than 35% or at risk of hemodynamic deterioration, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33) 4. Informed consent
Exclusion criteria
1. Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP \>90mmHg) 2. Presence of moderate to severe aortic insufficiency 3. Severe peripheral vascular disease 4. creatinine≥4mg/dL 5. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN 6. History of recent (within 1 month) stroke or TIA 7. Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L) 8. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite rate of 9 major adverse events | 30 days | included all-cause death, myocardial infraction, repeat revascularization, stroke, percutaneous coronary intervention failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-procedural hemoglobin decline | 30 days | The relative decrease in hemoglobin from the pre-procedural value to the nadir post-procedural value |
| Post-procedural platelet count decline | 30 days | The relative decrease in platelet count from the pre-procedural value to the nadir post-procedural value |
| RBC transfusion rate | 30 days | The percentage of patients who receive at least one unit of packed red blood cells |
| Serum interleukin-6 concentration | 30 days | Highest level of IL-6 during concentration |
| Duration of ECMO support | 30 days | Time on ECMO support |
| Length of hospital stay | 30 days | Time of hospitalization |
| Hospitalization cost | 30 days | The total cost until the discharge from the hospital |
| Use of intra-aortic balloon pump (IABP) | 30 days | Unplanned initiation of IABP after randomization |
| Each component of the composite major adverse events | 30 days | The incidence of all-cause death, myocardial infraction, repeat revascularization, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, or need for RRT |
Countries
China
Contacts
CONTACTXiaotong Hou, MD
PRINCIPAL_INVESTIGATORXiaotong Hou, MD
Beijing Anzhen Hospital
Outcome results
None listed