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Thrombolysis in Cardiac Arrest - TROICA
Description:
The goal of the trial was to evaluate the safety and efficacy of treatment with the fibrinolytic agent tenecteplase (TNK) compared with placebo among patients with cardiac arrest.
Study Design
Patients Enrolled: 827
Mean Follow Up: 30 days
Mean Patient Age: Mean age 65 years
Female: 18
Patient Populations:
Witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, and treated with advanced life support-CPR started within 10 minutes of onset
Exclusions:
In-hospital cardiac arrest, cardiac arrest of presumed noncardiac origin, obvious significant internal bleeding, known neurological impairment, known coagulation disorder, or known hypersensitivity to study medication
Primary Endpoints:
1) Survival at 30 days, and 2) hospital admission
Secondary Endpoints:
Return of spontaneous circulation, survival at 24 hours, survival to hospital discharge or day 30 whichever is first, and distribution of neurological and overall outcome scores
Drug/Procedures Used:
Patients were randomized to single bolus TNK (0.5 mg/kg) (n = 412) or placebo (n = 415) administered immediately after first vasopressor given during the cardiopulmonary resuscitation (CPR). Patients were randomized immediately after insertion of an intravenous line. CPR was to be administered for an additional 10 minutes after TNK bolus, and could continue for an additional 30 minutes as needed. A protocol amendment excluded patients with asystole from inclusion.
Principal Findings:
Initial ECG rhythm was ventricular fibrillation in 69% of patients, ventricular tachycardia in 2%, and pulseless in 29% of patients. Bystander CPR was performed in 30% of patients. Cause of cardiac arrest was myocardial infarction (MI) (62%), pulmonary embolism (4%), primary arrhythmia (21%), and unknown/other (13%). Adrenaline was given in 96% of cases.
The trial was discontinued prematurely at the recommendation of the data safety monitoring board for futility. There was no difference between groups in the primary endpoint of hospital admission (59.0% for TNK vs. 59.5% for placebo, p = 0.93) or the coprimary endpoint of survival at 30 days (18.2% vs. 20.2%, p = 0.51). There was also no difference in survival at 24 hours (35.4% vs. 37.9%, p = 0.51), return of spontaneous circulation (59.6% vs. 59.2%, p = 0.98), or survival at discharge or 30 days (18.8% vs. 21.0%). Major bleeding occurred in 8.9% of the TNK group and 7.4% of the placebo group (p = 0.53).
Interpretation:
Among patients with cardiac arrest, treatment with the thrombolytic agent TNK was not associated with a difference in the primary endpoints of hospital admission or survival at 30 days compared with placebo.
Approximately 70% of patients with cardiac arrest have underlying acute MI or pulmonary embolism. The authors hypothesized that since thrombolytic therapy is indicated for both of these underlying conditions, that it could be effective in the setting of cardiac arrest. Additionally, thrombolytic therapy was considered potentially beneficial since cardiac arrest is associated with systemic coagulation activation. Despite the rationale, no benefit of TNK was observed in the present study for treatment of cardiac arrest.
References:
Böttiger BW, Arntz HR, Chamberlain DA, Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62.
Presented by B.W. Boettiger, European Society of Cardiology Scientific Congress, September 2006.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Tachycardia, Ventricular, Out-of-Hospital Cardiac Arrest, Epinephrine, Pulmonary Embolism, Cardiopulmonary Resuscitation, Ventricular Fibrillation, Medical Futility, Fibrinolytic Agents, Electrocardiography, Tissue Plasminogen Activator
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