Abciximab as an Adjunct to High-risk Carotid or Vertebrobasilar Angioplasty: Preliminary Experience

Qureshi, Adnan I.; Suri, M. Fareed K.; Khan, Jehanzeb; Fessler, Richard D.; Guterman, Lee R.; Hopkins, L. Nelson

doi:10.1097/00006123-200006000-00007

Cited by 61 publications

(29 citation statements)

References 33 publications

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“…It also has been used as an adjunct to endovascular procedures or thrombolysis in an animal model 4 and for treatment of patients with ischemic cerebrovascular disease, including patients with acute ischemic stroke. [5][6][7][8][9][10][11][12] A dose-escalation study in 74 subjects suggested a low risk of symptomatic intracranial hemorrhage (ICH) when the agent was given up to 24 hours after onset of stroke. 13 The results of the study suggested that abciximab given as a bolus dose (0.25 mg/kg) followed by a 12-hour infusion at a rate of 0.125 g/kg per minute was reasonably safe.…”

mentioning

confidence: 99%

Emergency Administration of Abciximab for Treatment of Patients With Acute Ischemic Stroke: Results of an International Phase III Trial

Adams

Effron

Torner

et al. 2008

Stroke

351

197

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Background and Purpose-A previous randomized, placebo-controlled, double-blind study suggested that abciximab may be safe and effective in treatment of acute ischemic stroke. The current phase 3 study was planned to test the relative efficacy and safety of abciximab in patients with acute ischemic stroke with planned treatment within 5 hours since symptoms onset. Methods-An international, randomized, placebo-controlled, double-blind phase 3 trial tested intravenous administration of abciximab in 2 study cohorts using stratification variables of time since onset and stroke severity. The planned enrollment was 1800 patients. The primary cohort enrolled those patients who could be treated within 5 hours of onset of stroke. A companion cohort enrolled patients that were treated 5 to 6 hours after stroke as well as a smaller cohort of patients who could be treated within 3 hours of stroke present on awakening. The primary efficacy measure was the dichotomous modified Rankin Scale score at 3 months as adjusted to the baseline severity of stroke among subjects in the primary cohort. The primary safety outcome was the rate of symptomatic or fatal intracranial hemorrhage that occurred within 5 days of stroke. Results-The trial was terminated prematurely after 808 patients in all cohorts were enrolled by recommendation of an independent safety and efficacy monitoring board due to an unfavorable benefit-risk profile. At 3 months, approximately 33% of patients assigned placebo (72/218) and 32% of patients assigned abciximab (71/221; Pϭ0.944) in the primary cohort were judged to have a favorable response to treatment. The distributions of outcomes on the modified Rankin Scale were similar between the treated and control groups. Within 5 days of enrollment, Ϸ5.5% of abciximab-treated and 0.5% of placebo-treated patients in the primary cohort had symptomatic or fatal intracranial hemorrhage (Pϭ0.002). The trial also did not demonstrate an improvement in outcomes with abciximab among patients in the companion and wake-up cohorts. Although the number of patients was small, an increased rate of hemorrhage was noted within 5 days among patients in the wake-up population who received abciximab (13.6% versus 5% for placebo). Conclusions-This trial did not demonstrate either safety or efficacy of intravenous administration of abciximab for the treatment of patients with acute ischemic stroke regardless of end point or population studied. There was an increased rate of symptomatic or fatal intracranial hemorrhage in the primary and wake-up cohorts. (Stroke. 2008;39:87-99.)

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mentioning

confidence: 99%

Emergency Administration of Abciximab for Treatment of Patients With Acute Ischemic Stroke: Results of an International Phase III Trial

Adams

Effron

Torner

et al. 2008

Stroke

351

197

View full text Add to dashboard Cite

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“…8,31 The guidelines of the American Stroke Association do not recommend combined IA and IV therapy, 4 but previous reports concerning acute coronary syndrome and acute cerebral ischemia point out some advantages of the combined therapy, which include significant reduction in the total amount of thrombolytic drug required, easy conversion to mechanical thrombolysis, and the safety of ReoPro in acute ischemic stroke, even with a full dosage for acute coronary syndrome. 5,6,30,[34][35][36] Some previous studies performed the combined IV/IA therapy in a prospective manner, evaluating IA therapy for acute stroke following IV-tPA administration. In these studies, IV-tPA doses were at the reduced level of 0.6 mg/kg and the remaining dose of tPA was administered via the arterial route.…”

Section: Discussionmentioning

confidence: 99%

Therapeutic Results of Intra-Arterial Thrombolysis after Full-Dose Intravenous Tissue Plasminogen Activator Administration: Fig 1.

Yoo¹,

Won²,

Huh³

et al. 2010

AJNR Am J Neuroradiol

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“…The study did not include a control group. Qureshi et al 15 administered abciximab only prophylactically in 20 high-risk procedures involving not only the carotid arteries but also the vertebral and basilar arteries. Stents were not used in all patients.…”

Section: Discussionmentioning

confidence: 99%

Abciximab Bolus Injection Does Not Reduce Cerebral Ischemic Complications of Elective Carotid Artery Stenting

Hofmann

Kerschner

Steinwender

et al. 2002

Stroke

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Background and Purpose-Abciximab has been shown to significantly reduce thromboembolic complications of coronary artery stenting. A prospective, randomized study was performed to test whether abciximab has comparable beneficial effects in carotid artery stenting. Methods-Seventy-four consecutive patients undergoing elective stenting of the carotid artery were included in the study.Standard antithrombotic medication consisted of aspirin, clopidogrel, and heparin. In addition, half of the patients received an abciximab bolus of 0.25 mg/kg body weight given prophylactically before the intervention. Results-The procedure was successful in all but 1 patient. In patients receiving abciximab, ischemic complications consisted of 4 transient ischemic attacks, 1 minor stroke, 1 nonfatal major stroke, and 1 fatal stroke caused by cerebral hemorrhage. In the control group, 2 transient ischemic attacks and 1 major nonfatal stroke occurred. In summary, the total number of periprocedural ischemic events was 7 (19%) in the abciximab group and 3 (8%) in the control group. Nonischemic complications consisted of 1 inguinal hematoma requiring blood transfusions in each group. Conclusions-Abciximab

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Abciximab as an Adjunct to High-risk Carotid or Vertebrobasilar Angioplasty: Preliminary Experience

Cited by 61 publications

References 33 publications

Emergency Administration of Abciximab for Treatment of Patients With Acute Ischemic Stroke: Results of an International Phase III Trial

Emergency Administration of Abciximab for Treatment of Patients With Acute Ischemic Stroke: Results of an International Phase III Trial

Therapeutic Results of Intra-Arterial Thrombolysis after Full-Dose Intravenous Tissue Plasminogen Activator Administration: Fig 1.

Abciximab Bolus Injection Does Not Reduce Cerebral Ischemic Complications of Elective Carotid Artery Stenting

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