Coronary disease & ACSRandomised controlled trial
Intracoronary Low-Dose Recombinant Tissue Plasminogen Activator in Primary Percutaneous Coronary Intervention (PCI) for ST-Segment Elevation Myocardial Infarction and Large Thrombus Burden
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
Authors' conclusion
Among patients undergoing primary PCI for STEMI and large thrombus burden, intracoronary administration of alteplase was not superior to placebo in reducing the composite primary outcome of MACE at 30 days, myocardial blush grade 0/1, distal embolization, or failure to achieve ≥50% ST-segment resolution.
Study context
- Population
- Patients undergoing primary PCI for large territory STEMI and high thrombus burden207 received study drug
- Participants
- 210 patients
- Comparison
- Intracoronary low-dose alteplase vs placebo in primary PCI
- Alteplase 10 mgn = 68
- Alteplase 20 mgn = 69
- Placebon = 70reference
- Primary endpoint
- Composite of:
- Major adverse cardiac events (MACE) (CV death, re-infarction, cardiogenic shock or new-onset HF at 30 days)
- Myocardial blush grade 0/1
- Distal embolization
- Failure to achieve ≥50% ST-segment resolution at 30 minutes post-PCI
Primary result
As reported in the abstract
Relative risk
1.00
95% CI 0.76–1.31
P > 0.99
Events by treatment group
Combined alteplase vs Placebo
RR 1.00 (95% CI 0.76–1.31); P > 0.99
Further findings
Components of the primary outcome; each dose vs placebo
- Results consistent across all components and for each dose group vs placebo
Safety
| Outcome | Alteplase 10 mg | Alteplase 20 mg | Placebo | RR (95% CI) | P value | |
|---|---|---|---|---|---|---|
| VF during study drug administration · trend | Not reported in the abstract | Not reported in the abstract | 1.4% | 6.86 (0.91–51.4) | P = 0.06 | |
| 0.050.21520Relative risk (log scale) |
| Outcome | Alteplase 10 mg | Alteplase 20 mg | Placebo | Estimate | P value |
|---|---|---|---|---|---|
| Major or clinically significant bleeding | Not reported in the abstract | 1 events | Not reported in the abstract |
- Major or clinically significant bleeding: 1 patient in the trial
- VF during study drug administration: Combined alteplase 10.2%
Original publication
Intracoronary Low-Dose Recombinant Tissue Plasminogen Activator in Primary PCI for ST-Segment Elevation Myocardial Infarction and Large Thrombus Burden. J Am Coll Cardiol. Published 28 October 2025. doi:10.1016/j.jacc.2025.10.008
Summarised from the published abstract; every number is checked against it