- Design
- Pooled individual-patient analysis of six randomised trials
- Population
- 15,954 patients with STEMI given weight-adjusted tenecteplase
- Primary outcome
- Intracranial haemorrhage (169 events)
- Effect
- aOR 1.02 per mmHg SBP above 110; female sex aOR 1.49 (1.06–2.11); per 5 kg lower weight aOR 1.16
A pooled individual-patient analysis in the European Heart Journal (21 September) combined six tenecteplase trials in ST-elevation myocardial infarction (STEMI), from ASSENT-2 to STREAM-2 — 15,954 patients, of whom 169 had an intracranial haemorrhage.
Above a systolic pressure of 110 mmHg, each extra mmHg raised the odds by about 2%, with a steep rise beyond 160. Age mattered more at higher doses: the per-year increase in risk was about 1% at 30 mg and nearly 7% at 50 mg. Women had about 49% higher odds, and every 5 kg less body weight added about 16%. A model built from these factors discriminated reasonably well.
This matters most where fibrinolysis is still the default reperfusion strategy, as it is across much of India. The reduced-dose approach the STREAM trials used in older patients fits this pattern. Lowering systolic pressure before giving the drug is a modifiable step, though the analysis cannot prove that doing so lowers bleeding.
- Measure and treat systolic pressure before tenecteplase; risk climbs steeply above 160 mmHg
- Consider a reduced dose in older patients, as the STREAM trials did
- Weigh female sex and low body weight as added bleeding risks when choosing the dose
- Dose by weight with the actual weight, not an estimate, where the patient can be weighed
Why it matters
Intracranial bleeding is the complication that makes clinicians hesitate over fibrinolysis, and most of its drivers are visible at the bedside.
Don't overread it
These are associations from pooled trials — the study did not test whether lowering pressure or dose prevents haemorrhage.
The statistics, in plain English
An odds ratio of 1.02 per mmHg sounds small, but it compounds: 30 mmHg above the threshold multiplies the odds by roughly 1.8. A C index of 0.72 means the model ranks a bleeder above a non-bleeder about 72% of the time — useful, not definitive.
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