- Question
- To determine whether prehospital fibrinolysis followed by timely coronary angiography yields clinical outcomes similar to primary PCI in early ST-segment elevation myocardial infarction (STEMI).
- Design
- Randomized, open-label (no masking), phase 3 trial of 1892 patients with STEMI presenting within 3 hours of symptom onset who could not undergo primary PCI within 1 hour. The primary endpoint was assessed at 30 days.
- Population
- Patients with STEMI presenting within 3 hours of symptom onset in whom primary PCI could not be performed within 1 hour.
- Intervention
- Bolus tenecteplase (amended to half dose in patients aged 75 years or older), plus clopidogrel and enoxaparin before transport to a PCI-capable hospital. Emergency angiography was done if fibrinolysis failed; otherwise angiography was performed 6 to 24 hours after randomization.
- Control
- Standard primary percutaneous coronary intervention.
- Primary outcome
- Composite of death, shock, congestive heart failure, or reinfarction up to 30 days.
- Results
- The primary endpoint occurred in 116 of 939 patients (12.4%) in the fibrinolysis group and in 135 of 943 (14.3%) in the primary PCI group (relative risk 0.86; 95% CI 0.68 to 1.09; P=0.21). Emergency angiography was needed in 36.3% of the fibrinolysis group; the remainder underwent angiography at a median of 17 hours after randomization.
- Safety
- Intracranial hemorrhage was more frequent with fibrinolysis (1.0% vs. 0.2%; P=0.04); after the protocol amendment the rates were 0.5% vs. 0.3% (P=0.45). Nonintracranial bleeding was similar between groups.
- Conclusion
- Prehospital fibrinolysis with timely angiography achieved effective reperfusion in early STEMI when primary PCI was not possible within 1 hour, at the cost of a slightly higher risk of intracranial bleeding.
- Why it matters
- It supported prehospital fibrinolysis within a pharmaco-invasive strategy as a valid alternative when rapid access to primary PCI is not available, and highlighted the importance of dose adjustment in older patients.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026