Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00023595
First received: September 11, 2001
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Cardiovascular Diseases
Coronary Disease
Heart Failure, Congestive
Heart Diseases
Procedure: Coronary Artery Bypass
Other: Modern Medical Management
Procedure: Surgical Ventricular Restoration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Treatment for Ischemic Heart Failure (STICH)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • H01-Total mortality; H02-Long-term survival free of cardiac hospitalization [ Time Frame: H02 will be providing results in 2009; H01 results are anticipated in 2011-2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: H02: 2010; H01:2012 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: H02:2010; H01: 2012 ] [ Designated as safety issue: No ]
  • Exercise capacity [ Time Frame: H01: 2012; H02: 2010 ] [ Designated as safety issue: No ]
  • Treatment-specific prediction of primary endpoints by baseline measurements of myocardial ischemia and viability and by baseline and post-treatment measurements of LV size and function, and neurohormonal and pro-inflammatory cytokine levels [ Time Frame: H01: 2012-3, H02: 2010-11 ] [ Designated as safety issue: No ]

Enrollment: 2136
Study Start Date: January 2002
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Ho1: active medical therapy alone
Other: Modern Medical Management
State-of-the-art medical therapy for coronary artery disease and heart failure management.
Experimental: 2
H01: coronary bypass surgery (CABG) intervention and Medical Therapy
Procedure: Coronary Artery Bypass
The experimental group receives medical therapy and CABG, whereas the control group receives medical therapy alone.
Other: Modern Medical Management
State-of-the-art medical therapy for coronary artery disease and heart failure management.
Procedure: Surgical Ventricular Restoration
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 Ho1: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

  Hide Detailed Description

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 is 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.

ACCOMPLISHMENTS AND OTHER ISSUES:

The study is currently in follow-up mode, which will continue until at least 2010. Patient recruitment into Hypothesis 2 (H02) was completed in January 2006, with 1,000 patients enrolled worldwide. All recruitment ended on May 4, 2007, with total of 2,212 patients enrolled, and 1,212 patients enrolled into Hypothesis One (H01). To date, the study has already recruited more patients (815) than the number of patients enrolled in a landmark clinical trial of bypass surgery known as the Coronary Artery Surgery Study (CASS). The CASS trial, conducted almost 30 years ago, was the largest trial of bypass surgery until the current STICH trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic heart failure defined as New York Heart Association (NYHA) Class II-IV (within 3 months of entry)
  • LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
  • Coronary anatomy suitable for revascularization

Exclusion Criteria:

  • Clearly defined primary valvular heart disease indicating the need for valve repair or replacement
  • Concurrent cardiogenic shock, or requiring inotropic or intra-aortic balloon support
  • Percutaneous coronary intervention (PCI) planned for CAD treatment
  • Acute myocardial infarction within 30 days of study entry
  • More than one prior cardiac operation
  • Non-cardiac illness with life expectancy less than 3 years
  • Non-cardiac illness imposing substantial operative mortality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023595

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Robert Bonow Radionuclide Core Lab, Northwestern University
Principal Investigator: Arthur Feldman Neurohormonal Core Lab, Jefferson University
Principal Investigator: Robert Jones Clinical Coordinating Center, Duke University
Principal Investigator: Kerry Lee Data Coordinating Center, Duke University
Principal Investigator: Daniel Mark Economics and Quality of Life Core Lab, Duke University
Principal Investigator: Jae Oh Echocardiographic Core Lab, Mayo Clinic
Principal Investigator: Gerald Pohost Magnetic Resonance Imaging Core Lab, University of Southern California
Study Chair: Jean Rouleau Université de Montréal
Principal Investigator: Julio A Panza, MD Washington Hospital Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00023595     History of Changes
Other Study ID Numbers: Pro00018940, U01HL069012, U01 HL69009, U01 HL69010, U01 HL69011, U01 HL69012, U01 HL69013, U01 HL69015, U01 HL72683
Study First Received: September 11, 2001
Last Updated: September 25, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014