{"id":"8762f9b70ddf","type":"article","url":"https://hartvaat.nl/2019/01/01/laaggedoseerd-intracoronair-alteplase-bij-primaire-pci-jama-t-time/","title":"Laaggedoseerd intracoronair alteplase bij primaire PCI: JAMA T-TIME","title_en":"Effect of Low-Dose Intracoronary Alteplase During Primary Percutaneous Coronary Intervention on Microvascular Obstruction in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"JAMA","doi":"10.1001/jama.2018.19802","source_url":"https://doi.org/10.1001/jama.2018.19802","authors":["Peter J McCartney","Hany Eteiba","Annette M Maznyczka","Margaret McEntegart","John P Greenwood","Douglas F Muir","Saqib Chowdhary","Anthony H Gershlick","Clare Appleby","James M Cotton","Andrew Wragg","Nick Curzen","Keith G Oldroyd","Mitchell Lindsay","J Paul Rocchiccioli","Aadil Shaukat","Richard Good","Stuart Watkins","Keith Robertson","Christopher Malkin","Lynn Martin","Lynsey Gillespie","Thomas J Ford","Mark C Petrie","Peter W Macfarlane","R Campbell Tait","Paul Welsh","Naveed Sattar","Robin A Weir","Keith A Fox","Ian Ford","Alex McConnachie","Colin Berry"],"significance":7,"published":"2019-01-01","source_date":"2019-01-01","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The T-TIME trial showed that low-dose intracoronary alteplase during primary PCI did not reduce microvascular obstruction in STEMI patients. The negative result dampened enthusiasm for adjunctive intracoronary fibrinolysis during primary PCI.","created":"2026-07-03T10:27:42Z","updated":"2026-07-03T13:26:55Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JAMA T-TIME gerandomiseerde trial naar laaggedoseerd intracoronair alteplase tijdens primaire PCI voor vermindering van microvasculaire obstructie bij STEMI.","abstract_original":"IMPORTANCE: Microvascular obstruction commonly affects patients with acute ST-segment elevation myocardial infarction (STEMI) and is associated with adverse outcomes. OBJECTIVE: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with alteplase infused early after coronary reperfusion will reduce microvascular obstruction. DESIGN, SETTING, AND PARTICIPANTS: Between March 17, 2016, and December 21, 2017, 440 patients presenting at 11 hospitals in the United Kingdom within 6 hours of STEMI due to a proximal-mid-vessel occlusion of a major coronary artery were randomized in a 1:1:1 dose-ranging trial design. Patient follow-up to 3 months was completed on April 12, 2018. INTERVENTIONS: Participants were randomly assigned to treatment with placebo (n = 151), alteplase 10 mg (n = 144), or alteplase 20 mg (n = 145) by manual infusion over 5 to 10 minutes. The intervention was scheduled to occur early during the primary PCI procedure, after reperfusion of the infarct-related coronary artery and before stent implant. MAIN OUTCOMES AND MEASURES: The primary outcome was the amount of microvascular obstruction (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment. The primary comparison was the alteplase 20-mg group vs the placebo group; if not significant, the alteplase 10-mg group vs the placebo group was considered a secondary analysis. RESULTS: Recruitment stopped on December 21, 2017, because conditional power for the primary outcome based on a prespecified analysis of the first 267 randomized participants was less than 30% in both treatment groups (futility criterion). Among the 440 patients randomized (mean age, 60.5 years; 15% women), the primary end point was achieved in 396 patients (90%), 17 (3.9%) withdrew, and all others were followed up to 3 months. In the primary analysis, the mean microvascular obstruction did not differ between the 20-mg alteplase and placebo groups (3.5% vs 2.3%; estimated difference, 1.16%; 95% CI, -0.08% to 2.41%; P = .32) nor in the analysis of 10-mg alteplase vs placebo groups (2.6% vs 2.3%; estimated difference, 0.29%; 95% CI, -0.76% to 1.35%; P = .74). Major adverse cardiac events (cardiac death, nonfatal MI, unplanned hospitalization for heart failure) occurred in 15 patients (10.1%) in the placebo group, 18 (12.9%) in the 10-mg alteplase group, and 12 (8.2%) in the 20-mg alteplase group. CONCLUSIONS AND RELEVANCE: Among patients with acute STEMI presenting within 6 hours of symptoms, adjunctive low-dose intracoronary alteplase given during the primary percutaneous intervention did not reduce microvascular obstruction. The study findings do not support this treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02257294."}