The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
14
02
2020
accepted:
27
04
2020
pubmed:
20
6
2020
medline:
9
10
2020
entrez:
20
6
2020
Statut:
ppublish
Résumé
The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years. STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial. The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.
Sections du résumé
BACKGROUND
The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
METHODS
STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
DISCUSSION
The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.
Identifiants
pubmed: 32553932
pii: S0002-8703(20)30145-9
doi: 10.1016/j.ahj.2020.04.029
pii:
doi:
Substances chimiques
Fibrinolytic Agents
0
Tenecteplase
WGD229O42W
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
140-146Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosures The study is sponsored by Leuven Research & Development at the University of Leuven (KU Leuven) Belgium and supported by a grant from Boehringer Ingelheim GmbH to KU Leuven. The executive committee was responsible for the design and conduct of the trial. The academic authors vouch for the integrity and completeness of the data and analyses. Paul W. Armstrong has served as a consultant for Bayer and Merck. He has received research grants from CSL, Boehringer-Ingelheim, Bayer and Merck. Kris Bogaerts received consultancy fees through his institution from Boehringer Ingelheim GmbH. Robert Welsh has received research funding and honoraria from Astra Zeneca, Bayer, Boerhinger Ingelheim GmbH, and Pfizer. Peter Sinnaeve received Speaker’s and consultancy fees from Boehringer-Ingelheim. Patrick Goldstein reports travel support and lecture fees from Boehringer Ingelheim GmbH. Alain Pages is an employee of Boehringer Ingelheim GmbH. Thierry Danays is a former employee of Boehringer Ingelheim France, received consultancy fees from Boehringer Ingelheim GmbH. Frans Van de Werf received study grants to institution and lectures fees from Boehringer Ingelheim GmbH.