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Oral Anticoagulation and Antiplatelet Therapy and Peripheral Artery Disease New England Journal of M

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Title: Oral Anticoagulation and Antiplatelet Therapy and Peripheral Artery Disease New England Journal of M


1
Oral Anticoagulation and Antiplatelet Therapy and
Peripheral Artery Disease New England Journal
of Medicine, 357 217-227
  • Shayan Rayani, M.D.
  • Georgetown University Hospital

2
Epidemiology
  • The prevalence of peripheral atherosclerosis
    ranges from 3 in persons younger than 60 years
    to greater than 20 in persons 75 years of age
    and older
  • Risk factors include diabetes, smoking,
    hypertension, hyperlipidemia, family history and
    hyperhomocystinemia

3
Background
  • Patients with peripheral artery disease (PAD) are
    at increased risk of acute myocardial infarctions
    (MI), stroke or death from cardiovascular causes
  • Antiplatelet therapy reduces the risk of major
    cardiovascular diseases in patients with PAD
  • American Heart Association and American College
    of Cardiology consider oral anticoagulation in
    combination with aspirin (ASA) an appropriate
    alternative to ASA alone in patients with acute
    ST-elevation MIs

4
Hypothesis
  • Based upon the previous recommendation by the AHA
    and ACC, if anticoagulation antiplatelet
    reduces cardiovascular events in STEMIs then
    what about reducing the risk of cardiovascular
    events in patients with PAD?
  • Is anticoagulation antiplatelet therapy
    superior to antiplatelet therapy alone in PAD
    patients as far as reducing morbidity and
    mortality?

5
Type of Study
  • Randomized, open-label
  • Multi-center trial throughout the world (Canada,
    Poland, Hungary, Ukraine, China, Netherlands,
    Australia)
  • Study time frame was 3.5 years

6
Inclusion Criteria Criteria
  • Men and Women aged 35-85 with PAD
  • (defined as atherosclerosis of the arteries
    of the lower extremities, carotids, or
    subclavians)
  • Lower extremity PAD defined as intermittent
    claudication with objective evidence of PAD,
    ischemic pain at rest, non-healing ulcers or
    focal gangrene, previous amputation, arterial
    revascularization or blue toe syndrome
  • Carotid artery disease defined as TIA or stroke 6
    months before enrollment, carotid endarterectomy,
    or asymptomatic carotid stenosis of more than 50

7
Exclusion Criteria
  • Had an active indication for anticoagulation
  • Actively bleeding or at high risk for bleeding
    (use of NSAIDS long term, history of GI bleed)
  • Had a stroke within 6 months of the enrollment
  • Were on hemodialysis

8
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9
Run In Phase
  • All participants were started on oral
    anticoagulation (warfarin) and antiplatelet
    medications (acceptable agents were 81mg-325mg of
    ASA, ticlopidine, clopidogrel) during a 2-4 week
    trial period
  • If stable INR was achieved (2-3), no side effects
    occurred, and the patient was still willing to
    continue and adhere to therapy, then they were
    randomized

10
Patient Monitoring
  • INR values monitored monthly or more frequently
  • Followed for a minimum of 2.5 years to a max of
    3.5 years
  • Follow up assessments occurred every 3 months
    (where information was collected on
    hospitalizations and adherence)

11
Study Outcomes
  • Coprimary Outcome 1
  • MI, stroke, or death from cardiovascular causes
  • Coprimary Outcome 2
  • MI, stroke, severe ischemia of the peripheral or
    coronaries requiring urgent intervention, or
    death from cardiovascular causes
  • Safety Outcome
  • Life-threatening, moderate or minor bleeding

12
Statistical Analysis
  • Investigators used a log-rank statistic based on
    an intention-to-treat analysis to compare the
    treatment groups
  • Assessment of adherence to therapy was determined
    by comparing centers with good adherence (gt70 of
    patients adhering to therapy) to centers with
    poor adherence (lt70 of patients adhering to
    therapy)

13
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14
Coprimary Outcome Results
Coprimary Outcome 1
Coprimary Outcome 2
15
Bleeding Risk Between Groups
16
Subgroup Analysis
Life-threatening or moderate bleeding
Coprimary Outcome 1
17
Discussion
  • Overall no statistically significant risk
    reduction in cardiovascular events by adding on
    anticoagulation to existing antiplatelet therapy
    in patients with PAD
  • Statistically significant increase risk of
    bleeding in patients with combination
    anticoagulant and antiplatelet therapy (despite
    the fact that only 7.2 of the time was the INR
    above 3.0)

18
Limitations
  • Its possible that PAD patients are at greater
    risk for bleeding complications due to older
    population, more comorbidities, more systemic
    atherosclerosis
  • Open-label design allows patients to know
    medication they are getting (not blinded, no
    placebo effect)

19
Discussion
  • Study did not subset analyze whether the type of
    antiplatelet agents (ASA low dose, ASA high dose,
    clopidogrel, and ticlopidine) had an effect on
    bleeding risk
  • There were not enough patients enrolled in the
    study that were on clopidogrel and ticlopidine
    such that you could even differentiate if
    bleeding risk was worse in these groups vs. ASA

20
Applications to Clinical Practice
  • Considering the above study, we should be
    cautious with patients who have PAD that are on
    antiplatelet and need anticoagulation for other
    reasons (i.e. atrial fibrillation, PE, DVT)
  • We should closely follow these patients because
    of the increase bleeding risk on combination
    therapy
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