The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients

Autor: Thierry Danays, Alain Pages, Stream Study Groups, Peter Sinnaeve, Paul W. Armstrong, Robert C. Welsh, Kris Bogaerts, Frans Van de Werf, Patrick Goldstein
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Time Factors
Cardiac & Cardiovascular Systems
TENECTEPLASE
PRIMARY PCI
Population
PERCUTANEOUS CORONARY INTERVENTION
SEGMENT-ELEVATION
Tenecteplase
030204 cardiovascular system & hematology
Confirmatory trial
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Fibrinolytic Agents
Clinical endpoint
medicine
Humans
FIBRINOLYSIS
Prospective Studies
cardiovascular diseases
030212 general & internal medicine
Myocardial infarction
education
Aged
Randomized Controlled Trials as Topic
UNFRACTIONATED HEPARIN
education.field_of_study
Science & Technology
business.industry
ST elevation
Age Factors
INVASIVE STRATEGY
EFFICACY
Interim analysis
medicine.disease
RANDOMIZED-TRIAL
SAFETY
Emergency medicine
Conventional PCI
Cardiovascular System & Cardiology
ST Elevation Myocardial Infarction
Cardiology and Cardiovascular Medicine
business
Life Sciences & Biomedicine
medicine.drug
Zdroj: American Heart Journal. 226:140-146
ISSN: 0002-8703
Popis: 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. ispartof: AMERICAN HEART JOURNAL vol:226 pages:140-146 ispartof: location:United States status: published
Databáze: OpenAIRE
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