Dual antiplatelet therapy is a cornerstone of medical therapy for patients undergoing percutaneous coronary intervention (PCI) for coronary artery disease to prevent stent thrombosis. ACC/AHA (2009 focused update) guidelines recommend dual antiplatelet - PowerPoint PPT Presentation

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Dual antiplatelet therapy is a cornerstone of medical therapy for patients undergoing percutaneous coronary intervention (PCI) for coronary artery disease to prevent stent thrombosis. ACC/AHA (2009 focused update) guidelines recommend dual antiplatelet

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Prescribing Patterns of Proton Pump Inhibitors in Patients Treated with ... guidelines recommend dual antiplatelet therapy with aspirin plus a thienopyridine for ... – PowerPoint PPT presentation

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Title: Dual antiplatelet therapy is a cornerstone of medical therapy for patients undergoing percutaneous coronary intervention (PCI) for coronary artery disease to prevent stent thrombosis. ACC/AHA (2009 focused update) guidelines recommend dual antiplatelet


1
Prescribing Patterns of Proton Pump Inhibitors in
Patients Treated with Clopidogrel Post-Drug
Eluting Stent Placement Jill Cwik,
PharmD1, Ashish Shah, DO2, Sarosh Bukhari, DO2,
Alex Waldman,  Parag Patel, DO2,3, and M. Nagui
Sabri, MD, FACC, FSCAI2,3 (1)Department of
Pharmacy, (2)Department of Medicine, (3)
Department of Cardiology, Advocate Lutheran
General Hospital
INTRODUCTION
RESULTS
ADVERSE CARDIAC EVENTS
BASELINE CHARACTERISTICS
  • Dual antiplatelet therapy is a cornerstone of
    medical therapy for patients undergoing
    percutaneous coronary intervention (PCI) for
    coronary artery disease to prevent stent
    thrombosis. ACC/AHA (2009 focused update)
    guidelines recommend dual antiplatelet therapy
    with aspirin plus a thienopyridine for at least
    one year post drug-eluting stent (DES)
    implantation (Class IB). The current FDA
    approved thienopyridines include clopidogrel,
    prasugrel and ticlopidine with clopidogrel being
    the most commonly used thienopyridine.
  • The American College of Gastroenterology (ACG)
    and America Heart Association (AHA) recommend
    prophylactic proton pump inhibitors (PPIs) in
    order to prevent gastrointestinal (GI)
    complications such as ulceration and bleeding
    when patients are receiving aspirin and
    clopidogrel concomitantly following an acute
    coronary syndrome (ACS). Although the data are
    limited and retrospective in design, it has been
    demonstrated that there is a significant decrease
    in platelet aggregation when patients are taking
    PPIs with clopidogrel, resulting in adverse
    cardiac outcomes. To date, the only prospective
    trial published COGENT (The Clopidogrel and the
    Optimization of Gastrointestinal Events) did not
    show any difference in cardiovascular and GI
    outcomes in patients on dual antiplatelet therapy
    with aspirin and clopidogrel.
  • In November, the FDA published an alert regarding
    an interaction between clopidogrel and
    omeprazole. Omeprazole inhibits CYP2C19, which is
    responsible for conversion of clopidogrel to its
    active form. It has been shown that omeprazole
    reduces the conversion of clopidogrels active
    metabolite by about 45 and reduces clopidogrels
    effects on platelets by up to 47. With this
    decrease in the effect of clopidogrel there is
    potential to increase rates of in stent
    thrombosis and other adverse cardiac effects.

There were 6 patients in the PPI group and 14
patients in the no PPI group that had limited
information documented regarding their past
medical history.
OBJECTIVES
The purpose of the study is to determine if PPIs
are appropriately prescribed in patients
receiving clopidogrel following drug eluting
stent (DES) implantation at Advocate Lutheran
General Hospital. The PPI currently on formulary
is omeprazole and for those patients
concomitantly on clopidogrel the recommended PPI
for use is pantoprazole. The primary objectives
include evaluation of the prevalence of PPI
prescribed concomitantly with clopidogrel after
placement of a DES. This includes evaluation of
the indication for use, timing of PPI prescribed
and the incidence of cardiac events within one
year post implantation of the DES. The secondary
objectives include characterization of
prescribing patterns of PPIs in patients
receiving clopidogrel and the prevalence of
cardiac events post-DES placement. This data
collection is part of a multi-center analysis to
determine if there is an association with adverse
cardiac events including association with
in-stent thrombosis for up to one year post-DES
placement in patients who received a PPI
receiving concomitant clopidogrel therapy.
LIMITATIONS
There are several limitations to this study
including the lack of documentation including
medications at baseline and those patients were
taking up to one year post-DES. This lack of
documentation significantly decrease the sample
of patients that were ale to be included in the
analysis. In addition, a majority of the
patients did not have any documentation for the
indication of the PPI. Most of the PPIs are
available over the counter and the use is
difficult to track. There were a large amount of
patients that were lost during the follow up
period which is a limitation because the
potential adverse events would not be able to be
accounted for or tracked. Lastly another
limitation due to this study being retrospective
in design, patients were not able to be
questioned about compliance regarding their
medication use.
METHODS
This study involved a retrospective chart review
including the patients that were greater than 18
years of age and older that were prescribed
clopidogrel post-DES placement at Advocate
Lutheran General Hospital beginning September
2007 until September 2008 plus a one year
follow-up. Patients were identified using the
cardiology catheterization laboratory database
and were included if they had at least one DES
placed during September 2007 until September
2008. There were 390 patients that were eligible
and 279 that were included in this analysis.
Patients that were excluded included those that
were it was not known whether they continued
clopidogrel therapy for up at least up to one
year post DES placement.
CONCLUSIONS
There were 5911 patients in the PPI group that
had no medications listed at baseline or in the
available notes for up to 1 year follow-up in
Care Connection. In addition, there were 79
patients in the non-PPI group that had no
available medications at baseline or follow-up.
The adverse cardiac events evaluated in this
study included incidence of unstable angina,
non-ST segment elevation myocardial infarction,
and restenosis. Although there were a small
incidence in cardiac events, it was a
statistically significant difference in those
patients prescribed a PPI concomitantly with
clopidogrel. A statistical analysis was
performed to determine if there was an
association between which PPIs have a higher
incidence of cardiovascular events when
prescribed concomitantly with clopidogrel and
there was no statistically significant
difference. Although the sample size in this
study is limited, clinicians should be more
selective about which patient should be
discharged with a PPI after stent placement. It
is also important to ensure the medication list
is updated and the indication for medications are
appropriately documented. Indication for PPIs
should be addressed at stent implantation to
determine appropriateness of continuing upon
discharge.
PATIENT DEMOGRAPHICS
REFERENCES
  1. The American Heart Association. 2004 Heart and
    Stroke Statistical Update. Dallas, TX American
    Heart Association, 2004.
  2. Maisel W, Laskey W. Drug-Eluting Stents.
    Circulation. 2007 115e426-e427.
  3. Ong AT, Serruys PW. Drug-Eluting Stents.
    Presented at the Texas Heart Institutes
    symposium Current issues in Cardiology.
    Orlando, Florida, USA 2005.
  4. 2009 Focused Updates ACC/AHA Guidelines for the
    Management of Patients With ST-Elevation
    Myocardial Infarction and ACC/AHA/SCAI Guidelines
    on Percutaneous Coronary Intervention. J Am Coll
    Cardiol. 2009542205-2241
  5. ACC/AHA 2007 Guideline for the Management of
    Patients with Unstable Angina/Non-ST-Elevation
    Myocardial Infarction. J Am Coll Cardiol.
    200750(7)e1-e162.
  6. Ho MP, Maddox TM, Wang L, Fihn SD, et al. Risk of
    Adverse Outcomes Associated With Concomitant Use
    of Clopidogrel and Proton Pump Inhibitors
    Following Acute Coronary Syndrome. JAMA. 2009
    301(9)937-944.
  7. Juurlink DN, Gomes T, Ko DT, Szmitko PE, et al. A
    population-based study of the drug interaction
    between proton pump inhibitors and clopidogrel.
    CMAJ. 2009 180(7)713-718.
  8. Gilard M, Arnaud B, Cornily JC, Gregoire LG, et
    al. Influence of Omeprazole on the Antiplatelet
    Action of Clopidogrel Associated With Aspirin
    the randomized, double-blind OCLA (Omeprazole
    CLopidogrel Aspirin) study. J Am Coll Cardiol.
    200851256-60.
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