Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 176
- Locations
- 2
- Primary Endpoint
- Composite rate of 9 major adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinicians decide to perform PCI during ECMO support.
- •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)
- •Informed consent
Exclusion Criteria
- •Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP >90mmHg)
- •Presence of moderate to severe aortic insufficiency
- •Severe peripheral vascular disease
- •creatinine≥4mg/dL
- •Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN
- •History of recent (within 1 month) stroke or TIA
- •Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L)
- •Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.
Arms & Interventions
Standby cannulated ECMO
For standby cannulated ECMO procedures, femoral cannulas are inserted either by percutaneous approach or surgical approach. The primed circuit is connected to the inserted ECMO cannulas, clamps are kept on circuit, and ECMO is on standby during PCI. When PCI cause hemodynamic instability, clamps on circuit are removed, and VA-ECMO is initiated to maintain maintain adequate systemic pressure and perfusion.
Intervention: Standby cannulated ECMO (Procedure)
Prophylactic ECMO
Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI. Femoral cannulas are inserted either by percutaneous approach or surgical approach. Following cannula placement, VA-ECMO is initiated to maintain adequate systemic pressure and perfusion during PCI.
Intervention: Prophylactic ECMO (Procedure)
Outcomes
Primary Outcomes
Composite rate of 9 major adverse events
Time Frame: 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 Outcomes
- Platelet drop(30 days)
- Hemoglobin drop(30 days)
- RBC transfusion rate(30 days)
- Serum interleukin-6 concentration(30 days)
- Duration of ECMO support(30 days)
- Length of hospital stay(30 days)
- Hospitalization cost(30 days)
- Post-procedural hemoglobin decline(30 days)
- Post-procedural platelet count decline(30 days)
- Use of intra-aortic balloon pump (IABP)(30 days)
- Each component of the composite primary outcome(30 days)
Investigators
Xiaotong Hou
Professor
Beijing Anzhen Hospital