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Stroke: Year in Review 2007. South Carolina Society of Health-System Pharmacists Spring Symposium April D. Miller, PharmD South Carolina College of Pharmacy- USC Campus. True or False.

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stroke year in review 2007

Stroke: Year in Review 2007

South Carolina Society of Health-System Pharmacists Spring Symposium

April D. Miller, PharmD

South Carolina College of Pharmacy-

USC Campus

true or false

True or False

Warfarin therapy is generally contraindicated in atrial fibrillation patients greater than 75 years of age due to fall and bleeding risk

which of the following agents can be used for dvt prophylaxis in patients with ischemic stroke

Which of the following agents can be used for DVT prophylaxis in patients with ischemic stroke?

A: Enoxaparin

B: Unfractionated heparin

C: Fondaparinux

D: Abciximab

objectives
Objectives
  • Discuss new evidence for antiplatelet and anticoagulant therapy for stroke prevention
  • Present evidence on the use of DVT prophylaxis in stroke patients
  • Explain recent studies on non-pharmacologic issues in stroke care
epidemiology of stroke
Epidemiology of Stroke
  • 3rd leading cause of death in United States
  • Approximately 550,000 cases per year
  • Leading cause of disability

National Vital Statistics Reports 2007

disability due to stroke
Disability Due to Stroke

71%

% of Stroke Survivors

31%

20%

Heart and Stroke Facts: 1996 Statistical Supplement

antithrombotics and primary stroke prevention guidelines
Antithrombotics and Primary Stroke Prevention Guidelines
  • “Antithrombotic therapy (warfarin or aspirin) is recommended to prevent stroke in patients with non-valvular atrial fibrillation according to assessment of their absolute stroke risk, estimated bleeding risk, patient preferences, and access to high quality anticoagulation monitoring.” (Class I, Level A evidence)

Stroke 2006;37:1583-1633

slide8

Majority of elderly patients do not receive warfarin therapy

  • Study aim: Determine risk versus benefit of warfarin in an elderly population

Lancet 2007;370:493-503

bafta
BAFTA
  • Study design: prospective, randomized, open-label with blind endpoint assessment
  • Primary objective is compare frequency:
    • Fatal and non-fatal hemorrhagic or ischemic stroke
    • Intracranial hemorrhage
    • Clinically significant arterial embolism

Lancet 2007;370:493-503

bafta1
BAFTA
  • Patients
    • Inclusion criteria:
      • Age > 75 (mean age 81.5 years)
      • Atrial fibrillation diagnosed by ECG within 2 years
    • Exclusion criteria
      • Rheumatic heart disease
      • Major, non-traumatic hemorrhage or ICH within 5 years
      • Peptic ulcer disease or esophageal varices
      • BP > 180/110

Lancet 2007;370:493-503

bafta2
BAFTA
  • Interventions: Aspirin 75mg (n= 488) daily versus warfarin (n= 485) with target INR 2-3 x 5.5 years
    • Frequency or method of INR monitoring not altered by study
  • Results:
    • Ischemic stroke: Warfarin 1.6% versus Aspirin 3.4%
      • RR: 0.46, ARR: 1.8%, NNT: 56, P=0.003
    • Major hemorrhage: Warfarin 1.9% versus Aspirin 2%, P=0.74

Lancet 2007;370:493-503

bafta3
BAFTA
  • Discussion:
    • Selection bias for low-risk stroke patients
    • Patients potentially at lower risk for bleeding
  • Conclusion:
    • Warfarin is effective and safe for stroke prevention in elderly patients with atrial fibrillation

Lancet 2007;370:493-503

slide13

Background: Up to 75% of patients with hemiplegia post-stroke develop DVT and 20% develop PE

    • Unfractionated Heparin and Low Molecular Weight Heparin (LMWH) are shown to be beneficial
    • Optimal agent unknown

Lancet 2007;369:1347-55

prevail dvt prophylaxis
PREVAIL: DVT Prophylaxis
  • Study design: Prospective, randomized, open-label trial
    • Randomization stratified based on stroke severity (severe- NIHSS > 14, less severe NIHSS < 14)
  • Primary endpoint: cumulative occurrence of confirmed venous thromboembolism
  • Secondary endpoints: ICH, thrombocytopenia, adverse events

Lancet 2007;369:1347-55

prevail dvt prophylaxis1
PREVAIL: DVT Prophylaxis
  • Interventions initiated within 48 hours of stroke symptoms and continued ~10days:
    • Enoxaparin 40mg SC daily (n=604) OR
    • Unfractionated heparin 5000 units SC q12h (n=609)
  • Results
    • Frequency of VTE at day 14
      • Enoxaparin 10% versus UFH 18%
      • P= 0.0001, RRR= 43%, ARR= 8%, NNT= 13

Lancet 2007;369:1347-55

prevail dvt prophylaxis3
PREVAIL: DVT Prophylaxis
  • Results
    • Bleeding at end of treatment + 48h
      • Enoxaparin and UFH = 8%
    • Extracranial hemorrhage incidence slightly increased in enoxaparin group (1% n= 7 versus 0)

Lancet 2007;369:1347-55

prevail dvt prophylaxis4
PREVAIL: DVT Prophylaxis
  • Important considerations
    • 95% of DVTs detected were asymptomatic and detected routine venography
    • Comparison with BID unfractionated heparin
  • Conclusions
    • Enoxaparin more effective for DVT prophylaxis in ischemic stroke
    • Increased incidence of clinically significant bleeding with enoxaparin

Lancet 2007;369:1347-55

slide20
Pooled analysis of 3 prior studies (93 patients total)
    • DECIMAL
    • DESTINY
    • HAMLET

Lancet Neurol 2007;6:215-22

patient outcomes
Patient Outcomes

Surgery

Conservative

Lancet Neurol 2007;6:215-22

upcoming studies
Upcoming Studies
  • FASTER: Fast Assessment of Stroke and TIA to prevent Early Recurence
    • Use of clopidogrel, aspirin and simvastatin to reduce subsequent stroke in patients presenting with TIA
  • SELESTIAL: Trial of insulin to control blood sugar after acute stroke using MRI endpoints

http://www.clinicaltrials.gov

upcoming studies1
Upcoming Studies
  • PRoFESS: Prevention Regimen for Effectively avoiding Second Strokes
    • Aspirin/dipyridamole versus clopidogrel
  • CLEAR stroke: Combined approach to Lysis utilizing eptifibatide and rt-TPA in acute ischemic stroke

http://www.clinicaltrials.gov

true or

False

True or

Warfarin therapy is generally contraindicated in atrial fibrillation patients greater than 75 years of age due to fall and bleeding risk

which of the following agents can be used for dvt prophylaxis in patients with ischemic stroke1

Which of the following agents can be used for DVT prophylaxis in patients with ischemic stroke?

A: Enoxaparin

B: Unfractionated Heparin

C: Fondaparinux

D: Abciximab

references
References
  • Minino AM, Heron MP, Murphy SL, et al. Deaths: Final data for 2004. National Vital Statistics Reports; 55 (19). Hyattsville, MD: National Center for Health Statistics 2007.
  • Heart and Stroke Facts: 1996 Statistical supplement. Dallas: American Heart Association 1996.
  • Goldstein LB, Adams R, Alberts MJ, et al. Primary prevention of ischemic stroke. Stroke 2006;37:1583-1633.
  • Mant J, Hobbs R, Fletcher K et al. Warfarin versus aspirin for stroke prevention with atrial fibrillation (BAFTA): a randomised controlled trial. Lancet 2007;370: 493-503
  • Sherman DG, Albers GW, Bladin C, et al. The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of VTE after acute ischemic stroke (PREVAIL study): an open-label randomised comparison. Lancet 2007;369:1347-55
  • Handke M, Harloff A, Olschewski M, et al. Patent foramen ovale and cryptogenic stroke in older patients. N Eng J Med 2007;357:2262-8
  • Vahedi K, Hofmejer J, Juettler E, et al. Early decompressive surgery in malignant infarction of the MCA: a pooled analysis of three randomised trials. Lancet Neurol 2007;6:215-22.
  • Boden-Albala B, Sacco RL, Lee HS. Metabolic syndrome and ischemic stroke risk. Stroke 2008;39:30-35
stroke year in review 20071

Stroke: Year in Review 2007

South Carolina Society of Health-System Pharmacists Spring Symposium

April D. Miller, PharmD

South Carolina College of Pharmacy-

USC Campus