PURPOSE:
BACKGROUND:
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The rapidly escalating prevalence, high associated mortality, and apparent resistance to some pharmacological therapies of HF secondary to coronary artery disease has created difficult management dilemmas. Despite therapeutic advances with angiotensin-converting enzyme (ACE) inhibitors and beta-blockers, the mortality in HF patients can approach 30% to 40% one year after diagnosis.
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Since these studies are becoming widely used as the basis for selecting therapy for patients, accurate information on their value is greatly needed. The paucity of data available to clinicians who must daily make high-risk management decisions in patients with HF emphasizes the need for a properly designed randomized comparison of these therapies commonly used in clinical practice. The STICH Trial is designed to address this need for reliable information and define optimal management strategies in HF patients by comparing outcomes of surgical revascularization therapies with medical therapy in patients with clinical HF, left ventricular systolic dysfunction and coronary artery disease (CAD).
CRITERIA FOR INCLUSION OF SUBJECTS:
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Age 18 or over and competent to give informed consent.
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Left ventricular ejection fraction determination of <35% measured by CMR ventriculogram, gated SPECT ventriculogram, echocardiography, or contrast ventriculogram within 3 months of trial entry.
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Coronary anatomy suitable for CABG. Eligibility for SVR in addition to CABG will require dominant akinesia or dyskinesia of the anterior left ventricular wall amendable to SVR.
CRITERIA FOR EXCLUSION OF SUBJECTS:
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HF associated with nonischemic causes.
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Status 1 candidates listed for heart transplant.
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Recent acute myocardial infarction judged to be an important cause of left ventricular dysfunction within; more than 1 prior cardiac surgery.
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Coronary angioplasty within the 48 hours before randomization.
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Life-threatening diseases with a life expectancy of <3 years.
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Cardiogenic shock at the time of randomization, defined by need for intra-aortic balloon support or the requirement for intravenous inotropic support; conditions/circumstances likely to lead to poor treatment adherence; previous heart, kidney, liver, or lung transplant.
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Plan for percutaneous intervention of coronary artery disease; aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
RECRUITMENT OF SUBJECTS:
For more information, please refer to the STICH website or contact Nicklett Johnston, RN at 214-645-7728.