Approximately 70% of people that have an out-of-hospital cardiac arrest have underlying acute myocardial infarction or pulmonary embolism. Therefore, thrombolysis during cardiopulmonary resuscitation may improve survival.
The Thrombolysis in Cardiac Arrest (TROICA) trial was a prospective double-blind, randomised, placebo-controlled trial in 66 European emergency medical-service systems that compared thrombolysis with tenecteplase with placebo during cardiopulmonary resuscitation.
The TROICA study randomly assigned 1,050 adult patients with witnessed out-of-hospital cardiac arrest of presumed cardiac origin and with initiation of basic or advanced life support within 10 minutes after collapse, to receive tenecteplase or placebo during cardiopulmonary resuscitation. Adjunctive heparin or aspirin was not used.
The primary endpoint was survival at 30 days.
Secondary endpoints included hospital admission, return of spontaneous circulation, 24-h survival, survival to hospital discharge, and neurologic outcome of surviving patients.
After a blinded review of data from the first 443 patients, the TROICA Data and Safety Monitoring Board recommended discontinuation of enrolment of asystolic patients because of low survival. The trial was stopped prematurely for futility after 1,050 patients had been enrolled.
The 30-day clinical outcomes do not support use of tenecteplase over placebo for patients with out-of-hospital cardiac arrest. There was no significant difference in the primary endpoint of 30-day survival between the tenecteplase and placebo groups (14.7% versus 17.0%; p=0.36; relative risk 0.87; 95% confidence interval [CI] 0.65 to 1.15). Similarly, there were no significant differences in any of the secondary endpoints between groups. There were more intracranial haemorrhages in the tenecteplase group (2.7% versus 0.4%; p=0.006; relative risk 6.95; 95% CI 1.59 to 30.41).
- Tenecteplase without an adjunctive anti-thrombotic during CPR does not improve outcome for out-of-hospital cardiac arrest.