Coronary disease & ACSRandomised controlled trial
STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment–Elevation Myocardial Infarction: A Randomized, Open-Label Trial
- Randomised controlled trial
- investigator-initiated
- open-label
- multicentre
- 2:1 randomisation
Authors' 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)
Primary result
As reported in the abstract
Relative risk
0.96
95% CI 0.62–1.48
By group
Pharmaco-invasive
85.2%
≥50% ST resolution after last angiography · Residual median sum of ST deviations 4.5 mm · 30-day composite 12.8% (51/400)
Primary PCI
78.4%
≥50% ST resolution after last angiography · Residual median sum of ST deviations 5.5 mm · 30-day composite 13.3% (27/203)
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 |
- 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