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Arthur Stillman, M.D., Ph.D., PI Pamela Woodard, M.D., Study Co-chair - PowerPoint PPT Presentation


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R andomized  E valuation of Patients with S table Angina 
 C omparing U tilization of Diagnostic  E xaminations. Arthur Stillman, M.D., Ph.D., PI Pamela Woodard, M.D., Study Co-chair. COURAGE Trial. 2287 patients with stable angina (CCS I-III) At least one vessel with ≥ 70% stenosis

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arthur stillman m d ph d pi pamela woodard m d study co chair

Randomized Evaluation of Patients with Stable Angina 
Comparing Utilization of Diagnostic Examinations

Arthur Stillman, M.D., Ph.D., PI

Pamela Woodard, M.D., Study Co-chair

courage trial
COURAGE Trial
  • 2287 patients with stable angina (CCS I-III)
  • At least one vessel with ≥ 70% stenosis
  • Objective evidence of ischemia
  • Randomized to OMT vs. OMT + PCI
  • Mean f/u 4.6 years
  • No difference in death or MI oranginal symptoms

Boden WE, et al. N Engl J Med. 2007 Apr. 12;356(15):1503–1516.

primary aim
Primary Aim
  • To compare outcomes of participants with symptoms of stable angina or angina equivalent evaluated with an anatomic imaging strategy using CCTA as initial method of CAD diagnosis (Group A) to a combined functional and anatomic imaging strategy of SPECT MPI/ICA (Group B) as a guide to OMT.
secondary aims
Secondary Aims
  • To evaluate the ability of available prognostic indices to predict revascularization or MACE using CCTA information and to develop new indices using the RESCUE trial data.
  •  To determine the cost, effectiveness, and incremental cost-effectiveness of CCTA versus SPECT MPI/ICA in the evaluation of participants with symptoms of stable angina.
  •  To compare angina symptoms and self-reported health status of participants with symptoms of stable angina undergoing CCTA as initial method of CAD diagnosis to SPECT MPI/ICA as a guide to OMT.
eligibility
Eligibility
  • Patients ages 40 or older presenting with symptoms of stable angina CCS Class I to III or angina equivalent, with or without known CAD, with planned non-invasive imaging for diagnosis may enroll in the study
inclusion criteria
Inclusion Criteria
  • Willing and able to provide a written informed consent;
  • 40 years or older;
  • Presentation with symptoms of stable angina (CCS Class I to III) or angina equivalent with or without known CAD;
  • Planned non-invasive imaging for CAD diagnosis;
  • Able to tolerate CCTA or SPECT MPI per randomization as required by protocol, to be performed at an ACRIN-qualified facility with a RESCUE-qualified scanner.
exclusion criteria
Exclusion Criteria
  • Prior revascularization;
  • NOT SUITABLE TO UNDERGO CT WITH AN IODINATED CONTRAST AGENT:
    • Known allergy-like reaction to contrast media
    • Renal insufficiency or failure (GFR) < 30 mL/min/1.73 m2 
  • Atrial fibrillation or significant arrhythmia
  • AMI
  • Unstable angina and symptoms refractory to maximal oral and intravenous medical therapy (persistent CCS Class IV);
  • History of known left ventricular ejection fraction < 45%; Acute ischemia
  • Pregnant
  • Pacemaker
exclusion criteria cont
Exclusion Criteria cont.
  • Pulmonary edema or heart failure unresponsive to std medical therapy;
  • Valvular heart disease likely to require surgery in 18 months;
  • Congenital heart disease or cardiomyopathy likely to affect prognosis during follow up;
  • Significant hypertension unresponsive to medical therapy;
  • Severe non-cardiovascular comorbidity - survival < 12 months);
  • Prior imaging evaluation for this episode of symptoms within 72 hours
  • BMI >40kg/m2
what is omt
What is OMT?
  • Antiplatelet such as aspirin or clopidogrel, if participant is aspirin intolerant
  • Statin with target LDL cholesterol of 70 mg/dL
  • Anti-hypertensive/anti-anginal beta blocker with BP goal of 130/80 Hg/mm and reduced CCS angina class
  • Additional anti-hypertensive (amlodipine or ACE-inhibitor) as needed
  • Additional anti-anginal, as needed
what is omt1
What is OMT?
  • ACE-inhibitor (lisinopril) or angiotensin II receptor antagonist (Losartan) if ACE-inhibitor not tolerated, for all participants with LV EF <=40%
  • Attempt to raise HDL cholesterol, > 40 mg/dL in men and > 50 mg/dL in women, with exercise, extended release niacin or fibrates alone or in combination once LDL is at goal
  • Medications for diabetes control, with target HbA1c< 7%
  • Smoking cessation
  • Exercise regimen appropriate to diagnosis
  • Nutritional/dietary modification