Intravascular Optical Coherence Tomography Imaging - Length of Anti-Platelet Therapy After Drug Eluting Stent Placement (FDI-DAPT-ZES)

This study has been withdrawn prior to enrollment.
(Number of patients to meet individual IDE requirements was not obtained.)
Sponsor:
Collaborators:
Medtronic Vascular
Light Lab Imaging, Inc.
St. Jude Medical
Information provided by (Responsible Party):
Aloke V. Finn, Emory University
ClinicalTrials.gov Identifier:
NCT01219894
First received: October 8, 2010
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Frequency Domain Imaging to Determine Stent Strut Coverage and Duration of Anti-Platelet Treatment After Endeavor Stent Placement

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30% of the target stent as determined by OCT pullback of the target stent [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Primary Endpoint: The primary endpoint of this trial will be the frequency of near complete healing 3 months after Endeavor placement defined as a Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤30%.


Secondary Outcome Measures:
  • death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Occurrence of events after 3-month follow-up in the group with OCT guided early discontinuation of DAPT versus those adhering to standard of care (i.e. 12 months of DAPT). Events will be defined as death, stent thrombosis (Academic Research Consortium definition), myocardial infarction (defined as any evidence of troponin elevation above the upper limit of normal), and bleeding (TIMI Bleeding Classification (table 1)). We will also examine the relationship between underlying plaque morphology and 3 month follow-up OCT determined strut coverage.

  • Stent Thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    As defined by the Academic Research Consortium definition.

  • myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as any troponin elevation above the upper limit of normal

  • Bleeding [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    As defined by the TIMI Bleeding Classification.


Enrollment: 0
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
RUTTS Score <30%
Patients with evidence of complete healing of stent at 3 months
RUTTS<30%
Group with evidence of incomplete healing of the stent

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with a single DES (EndeavorTM, zotarolimus, Medtronic Vascular) will be enrolled in this study.

Criteria

Inclusion Criteria:

  • Any patient requiring percutaneous coronary intervention 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219894

Sponsors and Collaborators
Emory University
Medtronic Vascular
Light Lab Imaging, Inc.
St. Jude Medical
Investigators
Principal Investigator: Aloke Finn, MD Emory University
  More Information

Publications:
Responsible Party: Aloke V. Finn, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01219894     History of Changes
Other Study ID Numbers: IRB00045456
Study First Received: October 8, 2010
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Coronary Disease
Stent
Healing
Anti-platelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014