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BRIEF COMMUNICATIONS: P. D. Mitsias, M. Lu, B. Silver, D. Morris, J. R. Ewing, S. Daley, C. Lewandowski, A. Katramados, N. I. Papamitsakis, H. B. Ebadian, Q. Zhao, H. Soltanian-Zadeh, D. Hearshen, S. C. Patel, and M. Chopp MRI-guided, open trial of abciximab for ischemic stroke within a 3- to 24-hour window Neurology 2005; 65: 612-615 [Abstract] [Full text] [PDF]

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MRI-guided, open trial of abciximab for ischemic stroke within a 3- to 24-hour window

Pitchaiah Mandava, Jane A. Anderson, Thomas A Kent, The Michael E DeBakey VA Medical Center Stroke Program and the Dept. of Neurology, Baylor College of Medicine, Houston, TX   (8 November 2005)

MRI-guided, open trial of abciximab for ischemic stroke within a 3- to 24-hour window 8 November 2005
Pitchaiah Mandava, Baylor College of Medicine MEDVAMC 2002 Holcombe (127) Houston TX 77030, Jane A. Anderson, Thomas A Kent, The Michael E DeBakey VA Medical Center Stroke Program and the Dept. of Neurology, Baylor College of Medicine, Houston, TX Send Correspondence to journal: Re: MRI-guided, open trial of abciximab for ischemic stroke within a 3- to 24-hour window pmandava{at}bcm.tmc.edu Pitchaiah Mandava, et al.	We read with interest the excellent article by Mitsias et al [1] providing MRI evidence for early benefit of abciximab on stroke progression. This report joins others exploring abciximab in the acute stroke setting [2], including ours. [3] The purpose of this letter is to compare these protocols, explain the rationale for differences and report interim results. A common finding of the AbESTT trial [2] and Mitsias et al [1] are the uncertain long-term benefits. We hypothesized that efficacy would be improved with concomitant use of heparin based on reports of enhanced thrombolytic activity with this combination and that a lower abciximab dose would convey additional safety. [3] We noted a long track record of safety for abciximab in anticoagulated patients in the cardiac literature [3], yet anticoagulation is an exclusion in both these stroke protocols. [1,2] Our open label protocol utilizes a 0.2mg/kg bolus and a 12-hour infusion of 0.05ug/kg/hr in conjunction with short course intravenous heparin and permits a time window of 6 hours for anterior circulation and 24 hours for posterior. [3] This lower abciximab bolus dose showed identical efficacy with a lower incidence of bleeding in the dose-escalation precursor to AbESTT. [4] Results of our first 14 patients have been published [3] and 22 patients have now achieved 90-day outcomes and are reported here. Many were treated in the context of a surgical or other invasive procedure. The median baseline NIHSS of the 22 subjects was 22, considerably more severe than that in Mitsias et al [1] (median NIHSS: 10). Our safety results are comparable, including no symptomatic ICH, and a 12.5% incidence of asymptomatic hemorrhages (compared to 20% in Mitsias et al). There were no serious bleeding events. Although comparison is difficult because cohorts are dissimilar, functional outcome appears promising, with mean ± S.D. change in 3 month NIHSS of 12.5±7.86 vs. 5.7±4.4 in Mitsias et al (p<0.01; t-test). Because of concern that this lower dose may not sufficiently inhibit platelet GP IIb/IIIa activity, inhibition was measured in our most recent two patients. [5] Activity was reduced by 97 and 90% after the bolus and by 85% -73% at 1-2 hours after the 12-hour infusion. The initial values are within a range considered effective in the cardiac literature. [5] We agree with Mitsias et al that abciximab is a promising treatment in acute stroke. Our experience indicates that, used somewhat differently, it may provide an alternative for patients more severely affected. A Phase 2 trial is planned.* References 1. Mitsias PD, Lu M, Silver B, et al. MRI-guided, open trial of abciximab for ischemic stroke within a 3- to 24-hour window. Neurology 2005;65:612-615. 2. Abciximab Emergent Stroke Treatment Trial (AbESTT) Investigators. Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial. Stroke. 2005;36:880-90. 3. Mandava P, Lick SD, Rahman MA, et al. Initial safety experience of abciximab and heparin for acute ischemic stroke. Cerebrovasc Dis 2005;19:276-278 4.The Abciximab in Ischemic Stroke Investigators: Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose escalation study. Stroke 2000; 31: 601-609. 5. Coller BS. Monitoring platelet GP IIb/IIIa antagonist therapy. Circulation 1998;97:5-9. *Footnote: Since submission of our letter, the AbESTT II trial has been stopped (http://www.strokecenter.org/trials/trialDetail.aspx?tid=568&search_string=abestt) for a "high rate of intracranial hemorrhage", although it is said that unblinding is not expected until March. We plan on continuing our study, using the lower dose of abciximab described here and monitoring platelet GP IIb/IIIa inhibition. Disclosure: The authors report no conflicts of interest. The authors of the article had the opportunity to repsond to this Correspondence but did not.