Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standby cannulated ECMO, Prophylactic ECMO.
- Who it may be relevant to
- Registry conditions: ECMO, High-risk PCI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
Overview
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
- Procedure Standby 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. - Procedure Prophylactic ECMO
Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.
Primary outcome measures
- Composite rate of 9 major adverse events [Time frame: 30 days]
Secondary outcome measures (9)
- Post-procedural hemoglobin decline [Time frame: 30 days]
- Post-procedural platelet count decline [Time frame: 30 days]
- RBC transfusion rate [Time frame: 30 days]
- Serum interleukin-6 concentration [Time frame: 30 days]
- Duration of ECMO support [Time frame: 30 days]
- Length of hospital stay [Time frame: 30 days]
- Hospitalization cost [Time frame: 30 days]
- Use of intra-aortic balloon pump (IABP) [Time frame: 30 days]
- Each component of the composite major adverse events [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Clinicians decide to perform PCI during ECMO support.
- Age of ≥18
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT06274411 · KS2024014