Combined Intravenous and Intra-Arterial r-TPA Versus Intra-Arterial Therapy of Acute Ischemic Stroke

Lewandowski, Christopher; Frankel, Michael; Tomsick, Thomas A.; Broderick, Joseph P.; Frey, James L.; Clark, Wayne M.; Starkman, Sidney; Grotta, James C.; Spilker, Judith; Khoury, Jane; Brott, Thomas G.

doi:10.1161/01.str.30.12.2598

Cited by 568 publications

(330 citation statements)

References 19 publications

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“…The use of intracranial angioplasty and stenting for acute stroke has been reported in case series with recanalization rates that approach 90% [25][26][27]. Our recanalization rate of 88%, using multiple modalities, mirror these data, which is notably higher than for intravenous thrombolysis administered within 3 hr of stroke onset or intra-arterial thrombolysis alone [10,24]. Our data demonstrate the safety and efficacy of CBT in the hands of interventional cardiologists with carotid stent experience (in conjunction with stroke neurologists) for patients with acute stroke who are not eligible for intravenous thrombolysis.…”

Section: Discussionsupporting

confidence: 57%

“…Bleeding into the brain (ICH) is more strongly associated with death [39] than intramyocardial hemorrhage. ICH is not rare following CBT, with symptomatic ICH rates of 3-12% across published trials [4,13,20,24,27]. Mortality at 3 months is markedly higher for stroke patients (17-32%) [4,13] than the single digit mortality seen following hospital discharge for heart attack patients [40].…”

Section: Discussionmentioning

confidence: 99%

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Acute stroke intervention by interventional cardiologists

DeVries

White

Collins

et al. 2009

Cathet Cardio Intervent

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Objectives: To report the technical success and clinical outcomes of catheter-based therapy (CBT) for acute ischemic stroke in patients ineligible for intravenous thrombolysis. Background: Acute ischemic stroke is common but undertreated. CBT for acute ischemic stroke is a therapeutic option in selected patients who are not candidates for intravenous thrombolysis. Methods: Consecutive stroke patients who were ineligible for intravenous thrombolysis and underwent CBT were identified by retrospective chart review. Demographic information, National Institutes of Health Stroke Scale (NIHSS), procedural characteristics, and clinical outcomes during hospitalization and at 90 days follow up were collected. Experienced interventional cardiologists with the consultative support of stroke neurologists were on call for acute strokes. Results: A total of 33 acute ischemic stroke patients underwent emergency cerebral angiography, with 26 patients undergoing CBT. Successful ' 'culprit' ' artery recanalization was achieved in 23 (88%) of the 26 patients. In-hospital adverse events occurred in 4 (15%) patients, with intracerebral hemorrhage (ICH) (12%) representing the most common adverse event. The baseline NIHSS for patients who underwent intervention was 16.5 6 9.9 (median 16) and improved significantly to 9.9 6 8.7 (median 9) (P < 0.001) at hospital discharge. A modified Rankin score of two or less (indicating mild disability) was achieved in half (n 5 13) of the CBT treated patients. All cause mortality at 90 days was 8% (2/26). Conclusions: In selected patients, CBT provided by qualified interventional cardiologists supported by stroke neurologists, offers a safe and effective option for patients with acute stroke who are not eligible for intravenous thrombolysis. '

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Section: Discussionsupporting

confidence: 57%

Section: Discussionmentioning

confidence: 99%

Acute stroke intervention by interventional cardiologists

DeVries

White

Collins

et al. 2009

Cathet Cardio Intervent

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“…Although proper use of t-PA is beneficial in salvaging ischemic brain tissue (Busch et al, 1998;Clark et al, 1999;Hacke et al, 1995Hacke et al, , 1998Lewandowski et al, 1999;NINDS, 1995;Shen et al, 2004a,b;Hara et al, 1990), improper use of t-PA could induce serious brain damages (Fiorelli et al, 1999;Kano et al, 2000, Larrue et al, 2001Wardlaw et al, 2003). t-PA-induced brain damages are generally categorized into neurotoxicity and blood-brain barrier disruption.…”

Section: Discussionmentioning

confidence: 99%

“…In acute thromboembolic stroke, one major therapeutic strategy is to recanalize the occluded artery and rescue brain tissues from ischemic damage. The efficacy of fibrinolytic agents, such as the recombinant tissue plasminogen activator (t-PA), has been amply demonstrated to successfully recanalize arterial obstruction and improve clinical outcome Hacke et al, 1995Hacke et al, , 1998Lewandowski et al, 1999; National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group (NINDS), 1995). While this treatment is very successful, a significant number of patients who received fibrinolytic therapy showed increased risk of hemorrhage in a time-dependent manner (Dirnagl et al, 1999;Fisher, 2003;Jaillard et al, 1999).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of recombinant annexin 2 for fibrinolytic therapy in a rat embolic stroke model: A magnetic resonance imaging study

et al. 2007

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Efficacy of recombinant annexin 2 (rAN II) in a rat model of embolic stroke was examined using a magnetic resonance imaging (MRI) and histology. The right middle cerebral artery of male Wistar rats was occluded by autologous clots under anesthesia. Four doses of rAN II (0.125, 0.25, 0.5 and 1.0 mg/kg, n = 10 for each group) or saline (1 ml/kg, n = 10) were administrated intravenously within 5 min before clot infusion. Serial changes in apparent diffusion coefficient (ADC) and relative blood flow (CBF) were measured with the use of MRI in half of the animals in each group. The remaining half of the animals in each group was evaluated for hemorrhage and final infarct size by histology at 48 h after embolization. At 3 h after embolization, lesion volumes with ADC were abnormality and CBF in the peripheral lesion was improved in groups treated with 0.25, 0.5 and 1.0 mg/kg, but not 0.125 mg/kg, of rAN II in comparison with the saline-treated group (P < 0.05). Histological analyses were consistent with MRI findings. More importantly, no hemorrhagic transformation was documented in rats treated with 0.125 and 0.25 mg/kg of rAN II, whereas it was observed at higher doses. We concluded that rAN II at 0.25 mg/kg significantly reduced infarct size and improved CBF without hemorrhagic complications. rAN II is a novel compound that has the potential to be a promising fibrinolytic agent to treat embolic stroke.

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“…The NINDS trial demonstrated the efficacy of recombinant tissue plasminogen activator (rt‐PA) compared with a placebo control 22. Small randomized trial23 and two single‐group trials24, 25 reported improved efficacy of intravenous rt‐PA (IV rt‐PA) followed by endovascular therapy. Based on this preliminary work, the IMS III trial evaluated the efficacy of combining IV rt‐PA with intra‐arterial recanalization endovascular therapy against the IV rt‐PA alone control in moderate/severe stroke patients.…”

Section: Case Studymentioning

confidence: 99%

Bayesian selective response‐adaptive design using the historical control

Kim

Harun

Liu

et al. 2018

Statistics in Medicine

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High quality historical control data, if incorporated, may reduce sample size, trial cost, and duration. A too optimistic use of the data, however, may result in bias under prior‐data conflict. Motivated by well‐publicized two‐arm comparative trials in stroke, we propose a Bayesian design that both adaptively incorporates historical control data and selectively adapt the treatment allocation ratios within an ongoing trial responsively to the relative treatment effects. The proposed design differs from existing designs that borrow from historical controls. As opposed to reducing the number of subjects assigned to the control arm blindly, this design does so adaptively to the relative treatment effects only if evaluation of cumulated current trial data combined with the historical control suggests the superiority of the intervention arm. We used the effective historical sample size approach to quantify borrowed information on the control arm and modified the treatment allocation rules of the doubly adaptive biased coin design to incorporate the quantity. The modified allocation rules were then implemented under the Bayesian framework with commensurate priors addressing prior‐data conflict. Trials were also more frequently concluded earlier in line with the underlying truth, reducing trial cost, and duration and yielded parameter estimates with smaller standard errors.

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Combined Intravenous and Intra-Arterial r-TPA Versus Intra-Arterial Therapy of Acute Ischemic Stroke

Cited by 568 publications

References 19 publications

Acute stroke intervention by interventional cardiologists

Acute stroke intervention by interventional cardiologists

Efficacy of recombinant annexin 2 for fibrinolytic therapy in a rat embolic stroke model: A magnetic resonance imaging study

Bayesian selective response‐adaptive design using the historical control

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