Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
Condition: Cardiovascular Diseases; Coronary Disease; Heart Failure, Congestive; Heart Diseases
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare medical therapy with coronary bypass surgery and/or surgical
      ventricular reconstruction for patients with congestive heart failure and coronary artery
      disease (CAD).
    

Detailed description: 
      BACKGROUND:

      Congestive heart failure afflicts approximately five million Americans and is the leading
      cause of hospitalization in Americans over the age of 65. Most cases of congestive heart
      failure are due to CAD. Surprisingly little is known about the relative benefits of medical
      versus surgical therapy for patients with obstructive coronary disease and congestive heart
      failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary
      disease were conducted in the 1970s and did not include the systematic use of aspirin,
      arterial conduits, or lipid-lowering medications. In addition, patients with ejection
      fractions below 35% were specifically excluded from the three large randomized studies of
      medical therapy versus bypass surgery. While observational data from the 1970s and early
      1980s suggest a survival advantage associated with bypass surgery in patients with low
      ejection fraction and congestive heart failure, biases favoring the referral of the fittest
      of such patients for bypass surgery may have confounded these comparisons. In addition,
      medical therapy for congestive heart failure has improved dramatically over the past two
      decades. Thus, the choice of medical therapy versus bypass surgery for patients with
      congestive heart failure and obstructive coronary disease is usually decided by guesswork.
      This study is designed to provide a solid answer.

      PURPOSE:

      STICH is a multicenter, international, randomized trial that addresses two specific primary
      hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction
      who have coronary artery disease amenable to surgical revascularization.

      The first hypothesis is that restoration of blood flow by means of coronary revascularization
      recovers chronic LV dysfunction and improves survival, as compared to intensive medical
      therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more
      normal LV size improves survival free of subsequent hospitalization for cardiac cause
      compared to CABG alone.

      Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure
      (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG
      plus medical therapy. Patients eligible for all three therapies (Stratum B) will be
      randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG
      plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them
      inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions
      to CABG plus medical therapy versus CABG plus SVR plus medical therapy.

      The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into
      Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity,
      economics, and quality of life. Core laboratories for quality of life/economics, cardiac
      magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and
      radionuclide (RN) studies ensure consistent testing practices and standardization of data
      necessary to identify eligible patients and to address specific questions related to the
      stated hypotheses.

      IMPORTANCE OF RESEARCH:

      The most common cause of HF is no longer hypertension or valvular heart disease as it was in
      previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent
      cause of HF initiation and progression. HF is responsible for approximately 1 million
      hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely
      due to enhanced survival following acute myocardial infarction and other manifestations of
      CAD. No randomized trial has ever compared directly the long-term benefits of surgical,
      medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH
      trial is the first trial to compare the long term benefits of surgical and medical treatment
      in patients with ischemic HF. Although modern medical therapy for HF modestly improves
      quality of life, a more aggressive approach with the surgical therapies being studied in the
      STICH trial may produce even greater improvements. The common clinical practice of not
      offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive
      studies is not evidence-based. Since only those patients for whom intensive medical therapy
      is the only reasonable therapeutic alternative are excluded from this study, the results of
      the STICH trial should be applicable to most patients with CAD, HF, and systolic LV
      dysfunction. The results of the STICH trial will also establish whether measurements of
      neurohormonal and cytokine levels and genetic profiling are useful for directing patient
      management decisions, for monitoring the effectiveness of therapy, and for refining the
      optimal approach for selecting the treatment strategy most likely to be effective for the
      many of these patients.
    

Intervention name(s): CABG surgery plus MED; Active Medication Alone; CABG plus MED and SVR
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): CABG plus standard medication management for Coronary Artery Disease; Standard medication for coronary artery disease and heart failure management.; H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone
Other intervention name(s): Standard medications for management of CAD and heart failure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment