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Clinical Trial
. 2024 Dec;17(12):e014251.
doi: 10.1161/CIRCINTERVENTIONS.124.014251. Epub 2024 Dec 17.

Pharmaco-Invasive Strategy With Half-Dose Tenecteplase in Patients With STEMI: Prespecified Pooled Analysis of Patients Aged ≥75 Years in STREAM-1 and 2

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Clinical Trial

Pharmaco-Invasive Strategy With Half-Dose Tenecteplase in Patients With STEMI: Prespecified Pooled Analysis of Patients Aged ≥75 Years in STREAM-1 and 2

Kevin R Bainey et al. Circ Cardiovasc Interv. 2024 Dec.

Abstract

Background: In STREAM-1 (Strategic Reperfusion Early After Myocardial Infarction), excess intracranial hemorrhage occurred in patients aged ≥75 years receiving full-dose tenecteplase as part of a pharmaco-invasive strategy, whereas no further intracranial hemorrhage occurred after halving the tenecteplase dose. In STREAM-2 (Second Strategic Reperfusion Early After Myocardial Infarction), half-dose tenecteplase was an effective and safe pharmaco-invasive strategy in older patients with ST-segment-elevation myocardial infarction presenting within <3 hours, compared with primary percutaneous coronary intervention (PCI). We prespecified evaluating the efficacy and safety of a half-dose versus full-dose pharmaco-invasive strategy and compared the half-dose pharmaco-invasive strategy to primary PCI in patients aged ≥75 years.

Methods: We pooled data sets in patients aged ≥75 years from STREAM-1 and STREAM-2 receiving a pharmaco-invasive strategy versus primary PCI. Resolution of ST-segment-elevation after fibrinolysis and angiography was assessed, as was the relative risk of the primary composite of 30-day all-cause death, myocardial infarction, heart failure, and shock, along with bleeding.

Results: A total of 390 patients were included: 42 patients were randomized to full-dose pharmaco-invasive treatment, 205 patients to half-dose pharmaco-invasive treatment, and 143 patients to primary PCI. Half-dose versus full-dose pharmaco-invasive treatment resulted in similar proportions of patients achieving ≥50% ST-segment resolution posttenecteplase (63.2% versus 62.6%), with reduced intracranial hemorrhage (7.1% versus 0%, respectively). Half-dose pharmaco-invasive treatment and primary PCI also had similar proportions of patients with ≥50% ST-segment resolution postangiography (77.9% versus 72.4%; P=0.277) and comparable composite end points (23.4% versus 28.0%; relative risk, 0.90 [95% CI, 0.62-1.30]; P=0.567) without occurrence of intracranial hemorrhage.

Conclusions: Comparable efficacy exists between half- and full-dose tenecteplase pharmaco-invasive treatments with improved safety in patients with ST-segment-elevation myocardial infarction aged ≥75 years. Half-dose pharmaco-invasive therapy is a legitimate therapeutic option for elderly patients with ST-segment-elevation myocardial infarction unable to access timely primary PCI.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00623623. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02777580.

Keywords: fibrinolysis; intracranial hemorrhages; myocardial infarction; percutaneous coronary intervention; reperfusion.

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Conflict of interest statement

Dr Bainey reports personal fees from Bayer, AstraZeneca, Boehringer Ingelheim, and HLS Therapeutics. Dr Welsh reports research grants from AstraZeneca and personal and travel fees from AstraZeneca, Bayer, and Boehringer Ingelheim. Dr Arias-Mendoza reports grants from Merck and Novo Nordisk, as well as personal fees from Novartis, Roche, Bayer, Boehringer Ingelheim, and Asofarma. Dr Ristic reports grants from Boehringer Ingelheim and Novartis, as well as travel fees from AstraZeneca and Pfizer. Dr Kerr Saraiva reports consulting fees from Boehringer Ingelheim, AstraZeneca, Novo Nordisk, Lilly, Janssen, Daiichi-Sankyo, and Bayer and payment or honoraria for lectures, presentations, speakers bureaus, article writing, or educational events from Novartis, Nova Quimica Brazil, Boehringer Ingelheim, AstraZeneca, Novo Nordisk, Lilly, Janssen, Daiichi-Sankyo, and Bayer. Dr French reports an unrestricted educational grant to partly support STREAM-2 (Strategic Reperfusion Early After Myocardial Infarction) recruitment in Australia. Dr Musić reports a grant from Boehringer Ingelheim and travel fees from AstraZeneca and Pfizer. Dr Sinnaeve reports consulting fees from Boehringer Ingelheim to his institution (KU Leuven). Dr Westerhout reports consulting fees from Bayer Canada. Dr Danays reports consulting fees from Boehringer Ingelheim. Dr Van de Werf reports institutional grants from Boehringer Ingelheim. Dr Armstrong reports institutional and personal grants from Merck, Bayer, CLS, Ltd, Eli Lilly, and Boehringer Ingelheim, and personal fees from Merck, Boehringer Ingelheim, Bayer, and Novo Nordisk. The other authors report no conflicts.

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