Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

Beijing Anzhen Hospital176 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

ECMO High-risk PCI

Interventions

Standby cannulated ECMOPROCEDURE

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.

Prophylactic ECMOPROCEDURE

Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Composite rate of 9 major adverse events

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

Time frame: 30 days

Secondary Outcomes

Post-procedural hemoglobin decline

The relative decrease in hemoglobin from the pre-procedural value to the nadir post-procedural value

Time frame: 30 days

Post-procedural platelet count decline

The relative decrease in platelet count from the pre-procedural value to the nadir post-procedural value

Time frame: 30 days

RBC transfusion rate

The percentage of patients who receive at least one unit of packed red blood cells

Time frame: 30 days

Serum interleukin-6 concentration

Highest level of IL-6 during concentration

Time frame: 30 days

Duration of ECMO support

Time on ECMO support

Time frame: 30 days

Length of hospital stay

Time of hospitalization

Time frame: 30 days

Hospitalization cost

The total cost until the discharge from the hospital

Time frame: 30 days

Central Contacts

Xiaotong Hou, MD

CONTACT

010-64456631 xt.hou@ccmu.edu.cn

Data from ClinicalTrials.gov

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