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Title: Effect of Low-Dose Intracoronary Alteplase During Primary Percutaneous Coronary Intervention on Microvascular Obstruction in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
Authors: Ford, Tom ;McCartney, P.J.;Eteiba, H.;Maznyczka, A.M.;McEntegart, M.;Greenwood, J.P.;Muir, D.F.;Chowdhary, S.;Gershlick, A.H.;Appleby, C.;Cotton, J.M.;Wragg, A.;Curzen, N.;Oldroyd, K.G.;Lindsay, M.;Rocchiccioli, J;Shaukat, A.;Good, R.;Watkins, S.;Robertson, K.;Malkin, C.;Martin, L.;Gillespie, L.;Petrie, M.C.;Macfarlane, P.W.;Tait, R.C.;Welsh, P.;Sattar, N.;Weir, R.A.;Fox, K.A.;Ford, I.;McConnachie, A.;Berry, C.
Affliation: Central Coast Local Health District
Gosford Hospital
Issue Date: Jan-2019
Source: 321(1):56-68
Journal title: JAMA Cardiology
Department: Cardiology
Abstract: 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: Identifier: NCT02257294.
DOI: 10.1001/jama.2018.19802
ISSN: 0098-7484
Publicaton type: Journal Article
Keywords: Cardiology
Cardiovascular Disease
Drug Therapy
Heart Disease
Appears in Collections:Cardiology

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