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- Title
Early Administration of Reteplase Plus Abciximab vs Abciximab Alone in Patients With Acute Myocardial Infarction Referred for Percutaneous Coronary Intervention: A Randomized Controlled Trial.
- Authors
Kastrati, Adnan; Mehilli, Julinda; Schlotterbeck, Klaus; Dotzer, Franz; Dirschinger, Josef; Schmitt, Claus; Nekolla, Stephan G.; Seyfarth, Melchior; Martinoff, Stefan; Markwardt, Christina; Clermont, Günther; Gerbig, Hans-Wilhelm; Leiss, Johannes; Schwaiger, Markus; Schömig, Albert
- Abstract
Context: The optimal pharmacological strategy for bridging the delay between admission and performance of percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (MI) is not known. Objective: To assess whether early administration of reteplase plus abciximab produces better results compared with abciximab alone in patients with acute MI referred for PCI. Design, Setting, and Patients: Open-label, randomized controlled study conducted from May 3, 2001, through June 2, 2003, of 253 patients who were admitted to 13 community hospitals without catheterization facilities (n = 186) and to 5 hospitals with catheterization facilities (n = 67), with the diagnosis of an ST-segment elevation acute MI within 12 hours from onset of symptoms. Interventions: Patients received intravenously either the combination of a half-dose reteplase (two 5-U boluses, 30 minutes apart) with a standard dose of abciximab (0.25 mg/kg bolus, 0.125 µg/kg per minute infusion [maximum 10 µg/min for 12 hours]) or the standard dose of abciximab alone; all patients were then transferred for PCI. Main Outcome Measure: Final infarct size according to a single-photon emission computed tomography study with technetium Tc 99m sestamibi performed between 5 and 10 days after randomization in 228 patients (90.1% of entire sample). Results: Of the 253 patients enrolled, 125 were assigned to reteplase plus abciximab and 128 to abciximab alone. The median (interquartile range) of the final infarct size of the left ventricle was 13.0% (3.0%-28.0%) in the reteplase plus abciximab group and 11.5% (3.0%-26.3%) in the abciximab-alone group (P = .81). The mean difference in final infarct size of left ventricle between the reteplase plus abciximab group and the abciximab group was 1.3% (95% confidence interval [CI], –3.1% to 5.7%). Within 6 months after randomization, the composite secondary end point of death, recurrent MI, or stroke occurred in 8 patients (6.4%) in the r...
- Subjects
MYOCARDIAL infarction treatment; CORONARY disease; HEART diseases; CATHETERIZATION; THERAPEUTICS; CLINICAL trials; HEALTH outcome assessment
- Publication
JAMA: Journal of the American Medical Association, 2004, Vol 291, Issue 8, p947
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.291.8.947