Intravascular Optical Coherence Tomography Imaging to Determine the Length of Anti-Platelet Therapy After Drug Eluting Stent Placement
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 80 |
| Updated: | 10/2/2013 |
| Start Date: | November 2010 |
| End Date: | November 2012 |
| Contact: | Aloke Finn, MD |
| Email: | avfinn@emory.edu |
| Phone: | 404 686 2508 |
Frequency Domain Imaging to Determine Stent Strut Coverage and Duration of Anti-Platelet Treatment After Endeavor Stent Placement
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 is 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 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. Patients in the study will have 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 narrowings 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.
Inclusion Criteria:
- Any patient requiring PCI and meeting criteria (as determined by the performing
physician) for Endeavor Drug Eluting Stent Placement
Exclusion Criteria:
- Patients requiring >1 stent per treated lesion
- ST segment elevation MI (STEMI)
- inability to comply with study follow-up including 12 months of DAPT
- current or planned pregnancy (for women of childbearing age)
We found this trial at
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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