European heart journal · 2026
Intracranial haemorrhage following tenecteplase fibrinolysis for acute myocardial infarction.
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Armstrong Paul W, Danays Thierry, Westerhout Cynthia M
Аннотация
BACKGROUND AND AIMS: Intracranial haemorrhage (ICH) is a significant complication of fibrinolytic therapy for ST-elevation myocardial infarction (STEMI). The risk factors for ICH following tenecteplase (TNK) administration were evaluated, and a clinical risk prediction tool was developed.
METHODS: A pooled individual patient data analysis from STEMI patients who received weight-adjusted TNK with a consistent blood pressure exclusion criterion of >180/110 mmHg in six randomized controlled trials (ASSENT-2, ASSENT-3, ASSENT-3 PLUS, ASSENT-4 PCI, STREAM, STREAM-2) was undertaken. Logistic regression was used to model risk factors, and a nomogram was developed for individual risk prediction.
RESULTS: Among 15 954 patients, 169 developed ICH. Above a systolic blood pressure (SBP) threshold of 110 mmHg, each 1 mmHg increase conferred a 2% relative increase in ICH risk [adjusted odds ratio (aOR) 1.02, 95% confidence interval (CI) 1.01-1.03; P < .0001]; risk accelerated sharply beyond 160 mmHg. With increasing dose, the likelihood of ICH increased with age, rising from 1% per year (30 mg TNK) to nearly 7% per year with 50 mg. The multivariable model incorporating age, sex, SBP, body weight, and TNK dose with the age-dose interaction demonstrated good discrimination (C index 0.718; 95% CI 0.68-0.76). Female sex conferred a 49% increased ICH risk (aOR 1.49, 95% CI 1.06-2.11; P = .023), and each 5 kg decrease in body weight was associated with 16% increased odds of ICH (aOR 1.16, 95% CI 1.03-1.30; P = .014).
CONCLUSIONS: Dose reduction of TNK in older patients and SBP optimization before fibrinolytic administration represent modifiable strategies to potentially reduce ICH.
METHODS: A pooled individual patient data analysis from STEMI patients who received weight-adjusted TNK with a consistent blood pressure exclusion criterion of >180/110 mmHg in six randomized controlled trials (ASSENT-2, ASSENT-3, ASSENT-3 PLUS, ASSENT-4 PCI, STREAM, STREAM-2) was undertaken. Logistic regression was used to model risk factors, and a nomogram was developed for individual risk prediction.
RESULTS: Among 15 954 patients, 169 developed ICH. Above a systolic blood pressure (SBP) threshold of 110 mmHg, each 1 mmHg increase conferred a 2% relative increase in ICH risk [adjusted odds ratio (aOR) 1.02, 95% confidence interval (CI) 1.01-1.03; P < .0001]; risk accelerated sharply beyond 160 mmHg. With increasing dose, the likelihood of ICH increased with age, rising from 1% per year (30 mg TNK) to nearly 7% per year with 50 mg. The multivariable model incorporating age, sex, SBP, body weight, and TNK dose with the age-dose interaction demonstrated good discrimination (C index 0.718; 95% CI 0.68-0.76). Female sex conferred a 49% increased ICH risk (aOR 1.49, 95% CI 1.06-2.11; P = .023), and each 5 kg decrease in body weight was associated with 16% increased odds of ICH (aOR 1.16, 95% CI 1.03-1.30; P = .014).
CONCLUSIONS: Dose reduction of TNK in older patients and SBP optimization before fibrinolytic administration represent modifiable strategies to potentially reduce ICH.