Patient selection and protocol adherence may improve stroke outcomes1-4

Be proactive

  • Apply established standards of patient selection and follow proven treatment protocols
  • Review eligibility criteria in specific patient populations

Click on the links below to view information about Activase use in specific types of stroke patients.

Patient eligibility—elderly stroke patients
Activase (t-PA) may benefit older stroke patients5-7

In-hospital functional outcomes, according to age, in patients treated with Activase (t-PA)
  • *
  • Assessed by scores on modified Rankin scale (mRS) and National Institutes of Health (NIH) Stroke Scale at hospital discharge. Percentages do not always total 100 because of rounding.6

The risk of symptomatic intracranial hemorrhage (ICH) in patients >77 years of age may be increased and should be weighed against anticipated benefits.

  • Age should not necessarily preclude Activase (t-PA) treatment in eligible patients. The potential benefits and risks in older patients are comparable with those achieved in younger patients5-7:
    • – Similar proportions of favorable outcomes at discharge seen in patients >80 years of age (37%)† vs patients <80 years of age (30%) (P=0.52)6
    • – 54% (P>0.99) of patients in both groups had NIH Stroke Scale scores‡ <5 and 43% (P>0.99) showed marked improvement6

  • †
  • Represented by an mRS score of 0 to 1.
  • ‡
  • Represented by an mRS score of 0 to 5.

Patient eligibility—severe stroke patients
Activase (t-PA) may benefit severe stroke patients8,9

Effect of baseline NIH Stroke Scale score on outcome at 1 year

NIH = National Institutes of Health.

  • §
  • Possible range of NIH Stroke Scale scores = 0 to 42; a higher score reflects more severe disability.
  • ∥
  • Favorable outcome = modified Rankin scale score of 0 or 1.

Activase (t-PA)-treated patients presenting with severe neurologic deficit (eg, NIH Stroke Scale score >22) have an increased risk of symptomatic ICH within the first 36 hours.

At 1 year:

  • Greater percentages of patients on Activase had favorable outcomes vs placebo, regardless of the severity of baseline NIH Stroke Scale scores (post-hoc analysis of the 6- and 12-month data from the NINDS trial)8

Download this study

More eligible patients could benefit
FACT: 72% to 87% of eligible patients may go untreated despite the proven benefits of Activase (t-PA)10-12

Along with in-hospital stroke protocols, quality improvement (QI) programs are critical to delivering Activase (t-PA) to all eligible patients.

  • Review all patient exclusions
  • Evaluate hospital processes to streamline delays in patient assessment and evaluation
  • Promote a better understanding of patient eligibility requirements

Studies about quality improvement and patient exclusion in the use of Activase (t-PA) in acute ischemic stroke:

Barber PA, Zhang J, Demchuk AM, et al. Why are stroke patients excluded from TPA therapy? Neurology. 2001;56:1015-1020.

Deng YZ, Reeves MJ, Jacobs BS, et al. IV tissue plasminogen activator use in acute stroke. Neurology. 2006;66:306-312.

Cocho D, Belvís R, Martí-Fàbregas J, et al. Reasons for exclusion from thrombolytic therapy following acute ischemic stroke. Neurology. 2005;64:719-720.

Protocol adherence improves stroke outcomes
Quality improvement led to decreased protocol violations, improved safety, and increased Activase (t-PA) usage2

The Cleveland Clinic Health System experience

Adapted from Katzan IL, et al. Stroke. 2003;34:799-800.

  • One tertiary care center and 8 community hospitals.
  • #
  • Protocol deviations included: (1) treatment beyond 3 hours (n=7), anticoagulation within 24 hours (n=1), and deviations from blood pressure guidelines (n=3).
  • **
  • t-PA administration among all admitted ischemic stroke patients.

After implementing a quality improvement (QI) program to enhance stroke outcomes, the Cleveland Clinic Health System found evidence of improved outcomes2:

  • Rate of protocol deviations lowered from 33% to 17%
  • Rate of symptomatic ICH lowered from 13.4% to 6.4%
  • Increase from 1.8% to 2.7% in rate of Activase (t-PA) use among all admitted patients with ischemic stroke

Download this study

Indication: Activase is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS in the full prescribing information).

Safety Information: All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. Not all patients with acute ischemic stroke will be eligible for Activase therapy, including patients with evidence of recent or active bleeding; recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke; uncontrolled high blood pressure; or impaired blood clotting.


References:
1.
Graham GD. Tissue plasminogen activator for acute ischemic stroke in clinical practice: a meta-analysis of safety data. Stroke. 2003;34:2847-2850.
2.
Katzan IL, Hammer MD, Furlan AJ, Hixson ED, Nadzam DM, on behalf of the Cleveland Clinic Health System Stroke Quality Improvement Team. Quality improvement and tissue-type plasminogen activator for acute ischemic stroke: a Cleveland update. Stroke. 2003;34:799-800.
3.
Lopez-Yunez AM, Bruno A, Williams LS, Yilmaz E, Zurrú C, Biller J. Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage. Stroke. 2001;32:12-16.
4.
Bravata DM, Kim N, Concato J, Krumholz HM, Brass LM. Thrombolysis for acute stroke in routine clinical practice. Arch Intern Med. 2002;162:1994-2001.
5.
Engelter ST, Reichhart M, Sekoranja L, et al. Thrombolysis in stroke patients aged 80 years and older: Swiss survey of IV thrombolysis. Neurology. 2005;65:1795-1798.
6.
Tanne D, Gorman MJ, Bates VE, et al. Intravenous tissue plasminogen activator for acute ischemic stroke in patients aged 80 years and older. Stroke. 2000;31:370-375.
7.
Parnetti L, Silvestrelli G, Lanari A, et al. Efficacy of thrombolytic (rt-PA) therapy in old stroke patients: the Perugia stroke unit experience. Clin Exp Hypertension. 2006;28:397-404.
8.
Kwiatkowski TG, Libman RB, Frankel M, et al. N Engl J Med. 1999;340:1781-1787.
9.
Brandt T, Grau AJ, Hacke W. Severe stroke. Baillieres Clin Neurol. 1996;5:515-541.
10.
Barber PA, Zhang J, Demchuk AM, et al. Why are stroke patients excluded from TPA therapy? Neurology. 2001;56:1015-1020.
11.
Deng YZ, Reeves MJ, Jacobs BS, et al. IV tissue plasminogen activator use in acute stroke. Neurology. 2006;66:306-312.
12.
Cocho D, Belvís R, Martí-Fàbregas J, et al. Reasons for exclusion from thrombolytic therapy following acute ischemic stroke. Neurology. 2005;64:719-720.
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