1. Low-dose intracoronary alteplase during primary percutaneous coronary intervention in patients with acute myocardial infarction: the T-TIME three-arm RCT
- Author
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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, and Colin Berry
- Subjects
st elevation myocardial infarction ,myocardial reperfusion fibrinolysis ,thrombolytic therapy ,coronary vessels ,percutaneous coronary intervention ,angioplasty, balloon, coronary ,tissue plasminogen activator ,medical futility ,follow-up studies ,magnetic resonance imaging ,heart failure ,stents ,Medicine - Abstract
Background: Microvascular obstruction commonly affects patients with acute ST-segment elevation myocardial infarction and is independently associated with adverse outcomes. Objective: To determine whether or not a strategy involving low-dose intracoronary fibrinolytic therapy infused early after coronary reperfusion will reduce microvascular obstruction. Design: This was a multicentre, randomised, double-blind, parallel-group, placebo-controlled, dose-ranging trial. Setting: The trial took place at 11 hospitals in the UK between 17 March 2016 and 21 December 2017. Participants: Patients with acute ST-segment elevation myocardial infarction and a symptom onset to reperfusion time of ≤ 6 hours were eligible for randomisation. Radial artery access was a requirement, and further angiographic criteria included a proximal-to-middle coronary artery occlusion or impaired coronary flow in the presence of a definite thrombus in the culprit coronary artery. Exclusion criteria included a functional coronary collateral supply to the infarct-related artery, any contraindication to fibrinolysis and lack of informed consent. Additional exclusion criteria for safety were (1) requirement for immunosuppressive drug therapy for ≤ 3 months and (2) treatment with an antimicrobial agent. Intervention: A total of 440 participants were randomly assigned 1 : 1 : 1 to treatment with placebo (n = 151), 10 mg of alteplase (n = 144) or 20 mg of alteplase (n = 145) administered by manual infusion directly into the infarct-related coronary artery over 5–10 minutes. The intervention was scheduled to happen after reperfusion and before stent implantation. Outcomes: The primary outcome was the amount of microvascular obstruction (percentage of left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging at 2–7 days after enrolment. The primary analysis was the comparison between the 20 mg of alteplase group and the placebo group; if this comparison was not significant, the comparison of the 10 mg of alteplase group with the placebo group was considered as a secondary analysis. Sample size: A total of 618 patients (minimum of 558 patients). Recruitment was halted on 21 December 2017 given that conditional power for the primary outcome based on a prespecified analysis of the first 267 randomised participants was
- Published
- 2020
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