Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials - 08/03/25
on behalf of the
STREAM-2 Investigators
Highlights |
• | The STREAM-1 trial demonstrated similar outcomes with a PI strategy compared to primary PCI (PPCI) in STEMI patients presenting <3 hours of symptom onset and unable to undergo timely cardiac catheterization within 1 hour. |
• | However, an excess of intracranial hemorrhage (ICH) in those ≥75 years receiving PI treatment was observed early in the trial prompting a dose reduction amendment of tenecteplase (TNK) to half-dose after which no further ICH occurred. |
• | An analysis of STREAM-1 and STREAM-2 patients 60 to <75 years, found similar ST resolution and TIMI-3 patency with both half- and full-dose PI strategies with PI treatment (irrespective of TNK dose). These findings were also at least comparable than that achieved after their PPCI comparators. |
• | Whereas the risk of ICH with half-dose PI treatment was 2.1% compared to 1.5% with full-dose PI therapy, there was substantially less major (non-ICH) bleeding. Clinical outcomes were similar to those with their respective within trial PPCI comparators. |
ABSTRACT |
Background |
Previous studies indicate a safety risk with full-dose TNK in elderly patients. In a study of patients ≥60 years STREAM-2 (STrategic Reperfusion Early After Myocardial infarction-2), a pharmaco-invasive (PI) strategy with half-dose TNK was similar (in efficacy and safety) to primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) patients presenting <3 hours. While no treatment difference ± 75 years was observed, the role of this half-dose PI strategy in patients <75 years is unknown. In this comparison of STEAM-1 and -2, we analyzed PI strategies with full-dose (STREAM-1) versus half-dose TNK (STREAM-2) to evaluate their relative efficacy and safety in this younger STEMI cohort.
Methods |
We evaluated patients 60 to <75 years from STREAM-1 and STREAM-2 receiving PI treatment versus PPCI for their resolution of ST-elevation after fibrinolysis and angiography, primary efficacy composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, and safety events.
Results |
Among 1103 patients, 327 received a full-dose PI strategy (STREAM-1), 289 a half-dose PI strategy (STREAM-2) and 487 PPCI (338 in STREAM-1; 149 in STREAM-2). Half- compared to full-dose TNK resulted in similar proportions of patients achieving ST resolution ≥50% (71.2% vs 68.7%, P = .519): their ICH risks were 2.1% vs 1.5%, P = .605 respectively). Following angiography, PI patients had nominally better ST resolution ≥50% compared to their PPCI counterpart (STREAM-1: 87.7% vs. 83.2%, P = .120; STREAM-2: 88.2% vs. 81.0%, P = .048) with similar primary composite outcome at 30 days (STREAM-1: 14.4% vs. 16.3%, 0.90 [0.62, 1.31]; STREAM-2: 9.0% vs 8.1%, 1.29 [0.64, 2.61]). Major (non-ICH) bleeding markedly declined in STREAM-2 compared to STREAM-1 in both treatment groups (STREAM-1: 7.1% vs. 6.0%; STREAM-2: 0.3% vs. 0.7%).
Conclusions |
In STEMI patients 60 to <75 years presenting within 3 hours of symptoms, half-dose PI treatment appears as efficacious as a full-dose PI strategy with a low systemic bleeding risk. Half-dose PI treatment deserves consideration when timely PPCI is not attainable in this important STEMI sub-group.
Clinicaltrials.gov registration numbers |
NCT00623623, NCT02777580.
Le texte complet de cet article est disponible en PDF.Graphical Abstract |
Abbreviations : STREAM, ICH, STEMI, PPCI, PI, RR, ECG, TIMI, CABG, TRIANA, ESC
Plan
Vol 284
P. 20-31 - juin 2025 Retour au numéro
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