STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment–Elevation Myocardial Infarction: A Randomized, Open-Label Trial
Primary result · 30-day compositeResult — go to the resultRelative risk 0.96 95% CI 0.62–1.48Authors' conclusion
Halving the dose of tenecteplase in a pharmaco-invasive strategy in this early-presenting, older STEMI population was associated with electrocardiographic changes that were at least comparable to those after primary PCI. Similar clinical efficacy and angiographic end points occurred in both treatment groups. The risk of intracranial hemorrhage was higher with half-dose tenecteplase than with primary PCI.
Study context
- Population
- Patients ≥60 years with STEMI (≥2 mm ST elevation in 2 contiguous leads) unable to undergo primary percutaneous coronary intervention (PCI) within 1 hour
- Participants
- 401 vs 203
- Comparison
- Pharmaco-invasive strategy with half-dose tenecteplase vs primary PCI
- Pharmaco-invasiven = 401
- Primary PCIn = 203reference
- Primary endpoint
- ST resolution and composite of death, shock, HF or reinfarction (efficacy end points of primary interest)
- Follow-up
- 30 days (composite)
Methodological detailsinvestigator-initiated, open-label, multicentre, 2:1 randomisation
- Investigator-initiated
- Open-label
- Multicentre
- 2:1 randomisation
Primary result
30-day composite
Relative risk
0.96
95% CI 0.62–1.48
By group
Pharmaco-invasive
- ≥50% ST resolution after last angiography
- 85.2%
- Residual median sum of ST deviations
- 4.5 mm
- 30-day composite
- 12.8% (51/400)
Primary PCI
- ≥50% ST resolution after last angiography
- 78.4%
- Residual median sum of ST deviations
- 5.5 mm
- 30-day composite
- 13.3% (27/203)
≥50% ST resolution after last angiography
Residual median sum of ST deviations
30-day composite
As reported in the abstract
Further findings
Median time from randomization to tenecteplase or sheath insertion
TIMI flow grade 3 at last angiography
- ≈87% in both groups
Safety
| Outcome | Pharmaco-invasive | Primary PCI | |
|---|---|---|---|
| Intracranial haemorrhage | 1.5% | Not reported in the abstract | Primary PCI: not reported in the abstract |
- Intracranial haemorrhage: 3 were protocol violations (excess anticoagulation in 2, uncontrolled hypertension in 1)
Intracranial haemorrhage
- No intracranial bleeding in the primary PCI arm
Major nonintracranial bleeding
- Low in both groups
- <1.5%
Original publication
Summarised from the published abstract; every number is checked against it