Coronary Artery Disease Clinical Trial
Official title:
Frequency Domain Imaging to Determine Stent Strut Coverage and Duration of Anti-Platelet Treatment After Endeavor Stent Placement
Patients who receive drug-coated stents (as opposed to the less frequently used bare metal
stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or
Ticlid for one year. These guidelines apply to all patients with drug-coated stents,
regardless of the type of stent they received. The purpose of these medications is to
prevent a clot at the stent site when there is poor healing of artery tissues over the
stent. A clot is a serious concern because it can suddenly block blood flow to the heart and
cause a heart attack. These medications have been proven to be helpful in stent patients,
but they do have risks. The common side-effects are related to bleeding which in a few
patients can be serious. A patient may be at risk for forming a clot if they must put these
medications on hold for a surgical procedure to reduce the risk of bleeding. Plavix and
Effient are also expensive for patients who are underinsured or uninsured. There is interest
is finding a way to show that a patient's stent has healed properly before 12 months and
that they can safely stop these medications early.
This study is looking at a way to determine if patients who receive the Endeavor drug-coated
stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead
of 12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor
stent after 3 months.
A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to
look at how much a stent has healed. It allows imaging inside a heart artery and the ability
to see the healing of tissues over the stent.
There is a need to find a personalized approach to prescribing dual anti-platelet therapy
after a stent is placed in a coronary artery. Stenting involves inserting and expanding a
metal tube-shaped device in a heart artery where a blockage is limiting blood flow to the
heart muscle. This device stays in the artery permanently and the body's tissues grow over
it over time.
Patients in the study will have Optical Coherence Tomography (OCT) imaging done before stent
placement and again 3 months later in a follow-up angiography. Patients with sufficient
stent healing at 3 months will stop taking Plavix. Patients who have poor stent healing at 3
months will have to continue Plavix through 12 months. Patients will be called once a month
during the first year to see how they are doing and if they are taking their prescribed
medicines.
Other diagnostic methods that are used when patients have suspected heart blockages include
intravascular ultrasound (a device on a catheter that allows ultrasound imaging inside a
vessel), fractional flow reserve (a measurement of blood flow to determine if a blockages is
serious enough to need treatment), angiography (injection of dye into the arteries to look
for narrowing or blockages). These methods are used to look at the severity of heart
blockages once a patient already has signs and symptoms. They are not appropriate devices
for seeing if a patient's previous stent has healed properly after a certain period of time.
The long-term effectiveness of stenting procedures to treat symptomatic coronary artery
disease is limited by the need to take dual anti-platelet therapy (DAPT) with aspirin and
plavix to prevent complications related to clot formation within these devices due to
incomplete healing of the stented segment. While anti-platelet pharmacologic therapy can
minimize this risk, it is associated with an increased risk of serious bleeding events.
Currently all patients receiving drug eluting stents (DES) are advised to take plavix for
twelve months although a personalized approach for determining the appropriate duration of
anti-platelet therapy on a patient by patient basis would reduce both thrombosis and
bleeding, thereby improving the long-term safety of coronary revascularization procedures.
Optical coherence tomography (OCT) is a new high resolution imaging modality with the
potential to discern stent strut healing at follow-up and thus allow for individual
tailoring of anti-platelet regimens. Among the commercially available coated stents used in
the U.S., the zotarolimus eluting stents (ZES or Endeavor) has demonstrated superior
endothelialization and long term safety data in both preclinical and clinical studies and it
is very likely earlier discontinuation of anti-platelet therapy is safe. In this trial,
patients undergoing ZES placement for symptomatic CAD will undergo 3 months follow-up OCT
imaging to determine stent strut healing. Patients demonstrating complete healing will be
withdrawn from plavix (with aspirin continued) while those with evidence of incomplete
healing will be continued on DAPT for another 9 months. All patients will be followed
clinically for another 9 months and intercurrent adverse events recorded. In the end, this
research will establish OCT determined stent healing as a surrogate measure for determining
optimal anti-platelet therapy following DES implantation.
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Observational Model: Case Control, Time Perspective: Prospective
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