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J Thorac Cardiovasc Surg 2007;134:1540-1547
© 2007 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial

^a Division of Cardiovascular Medicine, Department of Medicine, Duke University Medical Center, Durham, NC
^b Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC
^c Duke Clinical Research Institute, Durham, NC
^d Division of Cardiology, Mayo Clinic, Rochester, Minn
^e Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill
^f Division of Cardiovascular Medicine, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, Calif
^g Division of Cardiology, Department of Medicine, Jefferson Medical College, Philadelphia, Pa
^h Division of Cardiology, Washington Hospital Center, Washington, DC
ⁱ National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md
^j Department of Medicine, University of Montreal, Montreal, Canada
^k Division of Cardiothoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC.

Received for publication March 28, 2007; accepted for publication May 11, 2007.

^_* Address for reprints: Eric J. Velazquez, MD, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27715. (Email: eric.velazquez{at}duke.edu).

	Abstract

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 
Objectives: The rationale and design of the Surgical Treatment for Ischemic Heart Failure trial is described. Before the Surgical Treatment for Ischemic Heart Failure trial, less than 1000 patients with ischemic cardiomyopathy had been studied in randomized comparisons of medical therapy versus coronary artery bypass grafting. Trial data reflect how these therapies were delivered more than 20 years ago and do not indicate the relative benefits of medical therapy versus coronary artery bypass grafting in contemporary practice.

Methods: Randomization of consenting patients with heart failure, left ventricular ejection fraction of 0.35 or less, and coronary artery disease is based on whether patients are judged by attending physicians to be candidates only for coronary artery bypass grafting or can be treated with medical therapy without coronary artery bypass grafting. Patients eligible for surgical ventricular reconstruction because of significant anterior wall akinesis or dyskinesis but ineligible for medical therapy are randomly assigned to coronary artery bypass grafting with or without surgical ventricular reconstruction. Patients eligible for medical therapy are randomly assigned between medical therapy only and medical therapy with coronary artery bypass grafting. Patients eligible for all 3 are randomly assigned evenly to medical therapy only, medical therapy and coronary artery bypass grafting, or medical therapy and coronary artery bypass grafting and surgical ventricular reconstruction. Major substudies will examine quality of life, cost-effectiveness, changes in left ventricular volumes, effect of myocardial viability, selected biomarkers, and selected polymorphisms on treatment differences.

Results: Enrollment is now complete in both STICH hypotheses. Follow-up will continue until sufficient end points are available to address both hypotheses with at least 90% power. The primary outcome of hypothesis 2 is expected to be reported in 2009. The primary outcome of hypothesis 1 is expected to be reported in 2011.

Conclusions: The Surgical Treatment for Ischemic Heart Failure trial is a National Heart, Lung, and Blood Institute–funded multicenter international randomized trial addressing 2 specific primary hypotheses: (1) coronary artery bypass grafting with intensive medical therapy improves long-term survival compared with survival with medical therapy alone, and (2) in patients with anterior left ventricular dysfunction, surgical ventricular reconstruction to a more normal left ventricular size plus coronary artery bypass grafting improves survival free of subsequent hospitalization for cardiac cause when compared with that with coronary artery bypass grafting alone.

	Introduction

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 
The revascularization of patients with coronary artery disease (CAD) with left ventricular (LV) systolic dysfunction (SD) and symptomatic heart failure (HF) has been the subject of much debate and surprisingly little research over the past 30 years.^1,2 Our current understanding of how best to treat these patients stems from subset analyses of the coronary artery bypass grafting (CABG)–medicine clinical trials performed in the 1970s and early 1980s and analyses of large registries of patients from the same era.^3-7 Although such analyses have generally demonstrated that patients with more advanced CAD and more severe LV dysfunction derive larger benefit from CABG relative to medical therapy (MED), in practice both cardiologists and surgeons have substantial uncertainty about whether these projected benefits are counterbalanced by the increased early risks of the surgical approach.

In 2002, the National Heart, Lung, and Blood Institute (NHLBI) funded the Surgical Treatment for Ischemic Heart Failure (STICH) trial to address 2 pressing clinical and policy questions regarding the management of patients with HF with surgically revascularizable CAD and decreased LV function: (1) Is contemporary CABG surgery superior to contemporary medical/secondary prevention therapy in prolonging survival in these patients? (2) Among patients with significant anterior wall dysfunction, does the addition of surgical ventricular reconstruction (SVR) to CABG improve hospitalization-free survival?

	Materials and Methods

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 
Study Design
In the absence of definitive data on the value of CABG in high-risk patients with LVSD, wide diversity exists among providers about how to select patients. Moreover, many patients who might be CABG candidates also have dominant anterior akinesia or dyskinesia that might be reasonable to reconstruct surgically at the time of CABG.⁸ Therefore the STICH trial was designed to let physicians first determine whether potential STICH patients were amenable to CABG after their routine clinical assessment. A threshold LV ejection fraction (EF) of 0.35 or less was established, with no lower limit set to preclude study entry. Physicians are encouraged to use any cardiac testing necessary to decide whether an individual patient is a candidate for CABG, SVR, or both. This philosophy encourages the use of standard practice to identify patients for whom responsible physicians are at equipoise about MED, CABG, and CABG with SVR and ensures that the STICH cohort has characteristics that now pose the greatest uncertainty in clinical decision making for patients with ischemic cardiomyopathy. Moreover, all information now commonly used by clinicians in deciding on surgical treatment for a subset of patients with ischemic cardiomyopathy will be available so that the value added by each component to the decision-making process can be evaluated (Table 1).

View larger version (20K): [in this window] [in a new window]   Figure 1. Surgical Treatment for Ischemic Heart Failure trial stratum and treatment assignment. CAD, Coronary artery disease; EF, ejection fraction; SVR, surgical ventricular reconstruction; MED, medial therapy; CABG, coronary artery bypass grafting.

Surgical therapy
Subjects randomly assigned to either CABG or CABG with SVR will receive the protocol-determined intervention no later than 14 days after randomization. CABG is performed by using at least 1 internal thoracic conduit, unless unavailable or inadequate. Use of cardiopulmonary bypass for CABG is left to the discretion of the surgeon. Patients with secondary mitral regurgitation judged to require mitral valve repair or replacement might undergo this procedure, although this is not mandated by protocol. The SVR typically occurs after CABG by means of any acceptable reconstruction method that consistently increases LVEF and decreases end-systolic volume. The general operative technique for SVR has been previously described.⁸ Use of a sizing device to judge appropriate LV chamber size and the decision of whether and how to patch the LV closure site are left to the operating surgeon.

Before and during hypothesis 2 (H2) patient recruitment, multiple educational opportunities will be made available to cardiac surgeons to refine surgical decision making and operative techniques for patients undergoing SVR. A lead cardiac surgeon at each site is responsible for initially certifying that all STICH surgeons meet qualification standards set by the Surgical Therapy Committee and for maintaining a high quality of surgical care for the duration of the trial. The most experienced cardiac surgeons at each site are certified as eligible to operate on randomized patients. The minimum requirement for certification is evidence of 25 patients undergoing CABG with LVEFs of 0.40 or less who were operated on with 5% or lower mortality. Before cardiac surgeons are certified to perform SVR on a randomized patient, they are required to perform at least 5 SVR procedures without a perioperative death and demonstrate consistent LV volume reduction after the operation.

Patient follow-up
The first follow-up for clinical status occurs at hospital discharge or at 30 days after randomization, whichever comes first. Participants are subsequently seen at 4-month intervals after randomization for the first year and no less than every 6 months after year 1. At these visits, interval assessments of HF and angina symptom status, current use of medications, and clinical end point data, including hospitalizations and procedures since the previous visit, are documented. Regardless of therapy received, all study participants are followed in this manner until study completion.

Statistical Issues
Hypothesis 1 power
All patients enrolled into stratum A and two thirds of patients enrolled into stratum B, those assigned to MED with or without CABG, comprise the hypothesis 1 (H1) study cohort. All-cause mortality is the primary end point of H1. H1 power estimates were based on an estimated 3-year mortality rate of 25% in the MED arm of the trial. This rate is slightly lower than the mortality observed in the control arm (no implantable cardioverter defibrillator implanted) of the ischemic cardiomyopathy cohort of the Sudden Cardiac Death in Heart Failure Trial.⁹ Approximately 400 deaths are required to achieve 90% statistical power for detecting a treatment difference consisting of a 25% reduction in mortality with MED with CABG. These 400 deaths are projected to occur if at least 1000 H1 patients are followed for an average of 6.5 years or 1200 patients are followed for an average of 5.5 years.

Hypothesis 2 power
All patients randomly assigned to stratum C and the two thirds of patients entered into stratum B assigned to either CABG or CABG with SVR comprise the H2 study cohort. A composite end point of survival free of cardiac hospitalization was chosen for H2 because no data exist to suggest that adding SVR to CABG improves survival over CABG alone. Moreover, this composite end point has validity for patients who would be likely to consent to adding SVR to a planned CABG. The planned enrollment of 1000 patients into H2 provides a 90% power to detect a 20% reduction in mortality and cardiac hospitalization by the addition of SVR to CABG, assuming that the 3-year event rate for those treated with CABG alone is 45% or higher.

Treatment crossovers
Crossovers between MED to CABG or CABG and SVR are anticipated within the first year because of the dynamic nature of coronary disease and the potential for deteriorating symptoms unresponsive to standard MED and requiring symptomatic relief. Patients randomly assigned to CABG and SVR might also not receive SVR because of intraoperative decisions that maximize patient safety. PCI is not regarded as a treatment crossover but rather as downstream medical care associated with any of the treatment strategies tested in the STICH trial. The sample sizes for both H1 and H2 allow for treatment crossovers of as much as 20% without sacrificing power so long as the control event rates remain as projected.

Secondary end points
Secondary end points for both hypotheses include all-cause mortality at 30 days, cardiovascular mortality, survival free of HF hospitalization, survival free of subsequent revascularization, need for cardiac transplantation, need for an LV assist device, all-cause hospitalization, LV size, LV function, total health care costs, cost-effectiveness, and quality of life. Other important efficacy parameters that will be evaluated include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke, sudden death with or without resuscitation, survival free of PCI, and survival free of CABG.

Approach to data analysis
The primary efficacy analyses will be performed according to the principle of intention to treat; that is, patients will be analyzed (and end points attributed) according to the treatment arm to which they were randomly assigned, regardless of subsequent crossover or nonadherence to the assigned treatment. Statistical comparisons will be performed by using 2-sided significance tests. For the primary comparisons of MED versus CABG in H1 and CABG versus CABG with SVR in H2, the log-rank test will be used, adjusting for the stratum in which the patients were enrolled.¹⁰ Cumulative event rates will be calculated according to the Kaplan–Meier method.¹¹ Event (or censoring) times for all patients will be measured from the time of randomization (time zero). Relative risks will be expressed as hazard ratios with associated confidence intervals and will be derived from the Cox proportional hazards model.^12,13 The Cox model will also be used in the assessment of treatment differences and analyses for many of the secondary end points. Interim analyses of the data will be performed and reviewed by an independent Data and Safety Monitoring Board appointed by the NHLBI. Interim treatment comparisons will be monitored with the use of 2-sided, symmetric O’Brien–Fleming boundaries generated with the Lan–DeMets -spending function approach to group-sequential testing.^14,15

Study Leadership
The STICH trial is an investigator-initiated, international study funded by the NHLBI of the National Institutes of Health. The STICH Steering Committee is comprised of principal investigators at all enrolling sites. An executive council is empowered by the Steering Committee to make day-to-day decisions (Appendix E1). However, all major executive council decisions are subject to review and approval of the Steering Committee.

Trial operations, site management and monitoring, statistical planning, and data analysis are being coordinated at the Duke Clinical Research Institute of Duke University in Durham, North Carolina. An end point classification committee blindly adjudicates all hospitalizations during follow-up. This committee functions independently of the operational team and is chaired by a cardiovascular specialist without direct access to potential STICH patients. A fully independent Data and Safety Monitoring Board (Appendix E2) has been empowered to review unblinded safety and efficacy data no less than twice yearly by using the prespecified early termination rules described in the previous section.

	Results

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 
Enrollment is now complete in both STICH hypotheses. Follow-up will continue until sufficient end points are available to address both hypotheses with at least 90% power. The primary outcome of hypothesis 2 is expected to be reported in 2009. The primary outcome of hypothesis 1 is expected to be reported in 2011.

	Discussion

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 
Rationale for Contemporary Evaluation of Survival Benefit Associated With Addition of CABG to MED in Patients With Ischemic Cardiomyopathy
Randomized trials of CABG surgery enrolling 2234 patients between 1971–1979 established the safety of surgical revascularization in patients with preserved LV systolic function and chronic stable angina.⁵ Improved survival after CABG compared with that with MED alone was shown for patients with angina and flow-limiting stenoses of the left main coronary artery or multiple coronary arteries, especially in patients with severe stenosis of the proximal left anterior descending coronary artery. The Coronary Artery Surgery Study (CASS) was the only one of these 7 early studies to stratify randomization of the 780 patients enrolled based on LVEF (0.35–0.50 vs >0.50), angiographic extent of CAD (1-, 2-, or 3-vessel stenosis), and presence or absence of angina at the time of enrollment. At the conclusion of 10 years of follow-up, 82 (21%) of 390 patients randomly assigned to receive MED alone had died, and 70 (18%) of 390 patients randomly assigned to receive MED plus CABG had died (P = .25).¹⁶ The subgroup of patients with an LVEF of 0.35 to 0.50 was the only stratified subgroup in CASS to show a significant survival difference.³ Of the 160 patients in CASS who had LVSD, 32 (38%) of the 82 MED-treated patients died, whereas 16 (21%) of the 78 patients who underwent CABG (P = .01) died. However, the 54-patient subset of CASS who had LVSD but no angina did not derive a statistical survival advantage from CABG (P = .12).

Since the initial description of the clinical syndrome of ischemic cardiomyopathy more than 3 decades ago,¹⁷ the clinical care of patients with CAD and LVSD has undergone a dramatic evolution. When the last patient was randomized between CABG and MED during the time of CASS enrollment, MED for patients with HF, LVSD, and CAD was limited to digitalis and diuretics, which are medications now known to have a neutral effect on mortality. Current American College of Cardiology/American Heart Association guidelines highlight the major advances in pharmacotherapy and device therapy that have improved the quality of life and survival of patients with CAD, HF, and LVSD.¹⁸ However, the evidence base remains deficient in identifying which, if any, patients with CAD and LVSD should receive revascularization. Although specific clinical problems in this population, such as severe angina, are used to decide on revascularization strategies, the vast majority of patients with ischemic cardiomyopathy have limited or no angina and fall into a gray zone, where clear evidence for adding CABG to MED is either absent or outdated. Thus, divergent views have evolved among clinicians since the reports of the CASS data as to the most appropriate diagnostic and management strategy for patients with ischemic cardiomyopathy. Table E3 ^18-22 summarizes current guideline recommendations as they relate to the selection of CABG as a treatment option for patients with poor LV function.

Rationale for a Prospective Assessment of Myocardial Viability
Viability testing by various modalities is currently used by many clinicians to select patients for surgical intervention. Positron emission tomography has been considered by many to be the gold standard, but high cost and lack of widespread availability has led to limited use.²⁵ Thallium- or technetium-based nuclear scintigraphy, using one of many rest or stress imaging protocols, has become more widespread and has acceptable sensitivity and specificity.²⁶ Because it is readily available, dobutamine stress echocardiography to demonstrate augmentation of the contractile response has become the test of choice for assessing tissue viability at many institutions.²⁷ Although not as widely available, delayed contrast enhancement on cardiovascular magnetic resonance scanning is a reliable method to detect nonviable myocardium.²⁸ Although guidelines recommend that the presence or absence of viable myocardium can be considered in the decision as to whether revascularization should be recommended,^18-21 the strength of this recommendation varies among the individual guidelines (Table E3). Therefore extensive heterogeneity exists on how clinically available structural and functional imaging is incorporated into treatment decisions for patients with CAD and LVSD.

Viable myocardium in patients with LVSD and CAD appears to predict contractile recovery in dysfunctional myocardial segments, regardless of whether patients receive MED alone or CABG.²⁹ Although no studies have validated the use of viability testing regardless of the imaging modality in a prospective randomized trial with a survival end point, many retrospective nonrandomized observational series have been published that evaluated the association between the results of viability testing and short-term clinical outcomes. Systematic reviews^30,31 suggest that, when present, myocardial viability is associated with improved short-term (18 month) survival in patients referred to CABG, but conversely, the absence of viability is not necessarily associated with disparate outcomes between medically and surgically treated patients. Unfortunately, a multitude of confounding factors, including the lack of standard definitions for viability, the heterogeneous nonrandomized populations studied, and the lack of uniform MED received, limit the applicability of these data to current practice. Although the use of viability imaging is predicated on an ability to predict functional recovery, failure to improve LV function is not necessarily associated with a worse clinical outcome.³² Because CABG in patients with LVSD continues to be associated with substantial operative risk, when and how viability imaging is used to reliably predict long-term outcomes are critical questions that require definitive answers.

Rationale for SVR as an Adjunct to CABG for Patients With Predominant Anterior Akinesia
Surgical reconstruction of akinetic, dyskinetic, or aneurysmal segments might theoretically decrease LV wall stress, myocardial oxygen consumption, and stroke volume while preserving or improving contractile function in the remaining ventricle. In the CASS registry population of LVSD, more than 30% of the patients who underwent CABG underwent concomitant ventricular reconstruction surgery.⁴ These early linear plications or resections of dyskinetic scar commonly deformed the LV cavity into a box-like shape and did not consistently improve ventricular performance.³³ Intracavity reconstruction techniques were developed for repairing defects left by aneurysmal resection that reduced LV cavity size but retained a more elliptical configuration of the ventricle.³⁴ Dor and colleagues⁸ advocated the use of SVR not only in patients with dyskinetic scar but also in those with only akinetic myocardial segments. A preserved epicardial covering of myocardial fibrosis might make these akinetic zones appear normal at the time of cardiac operation, but palpable thinning usually can be appreciated in the arrested decompressed heart. Unlike earlier LV aneurysmectomy that removed myocardial scarring or the Batista operation³⁵ that reduced LV size by means of excision of portions of the LV wall, the objective of the SVR operation is to reshape and decrease the size of the left ventricle by decreasing the circumference of the endocardial scar through an incision in normal epicardium. Myocardial scar is occasionally excised during SVR, but, commonly, no tissue is removed at the time of the operation. The intrinsic scar or an extrinsic patch can be used during closure of the left ventriculotomy to decrease linear wall tension and avoid the restrictive physiology of undersizing the left ventricle.

The RESTORE registry group reported on 1198 patients who underwent SVR at 11 centers, with a 5.1% operative mortality and an 88% 18-month survival rate for all patients.³⁶ A recent report from the Society of Thoracic Surgery database³⁷ suggests that SVR is being performed with increasing frequency for the treatment of patients with HF, CAD, and LVSD; however, the perioperative risk might be more substantial. In this 2002–2004 US sample, 731 patients underwent SVR at 141 of 576 reporting centers. The perioperative 30-day outcomes were 9.3% for mortality and 33.5% for any major complication. Use of SVR as an adjunct to CABG for patients with LVSD cannot yet be justified on firm evidence because no reports are available comparing outcomes of CABG and SVR with CABG alone in similar populations. H2 of the STICH trial was designed to address this important question.

Current Status of the STICH Trial
The first patient was randomized into the STICH trial in July 2002. Since then, the STICH Steering Committee has approved 3 protocol amendments to facilitate successful completion of trial enrollment (Appendix E3). Randomization of 1000 planned subjects into H2 was completed in January 2006 and led to the closure of strata B and C to further enrollment. This represents the largest randomized comparison of 2 cardiac surgical strategies. H2 primary end point results are expected to be published in 2009. In June 2006, STICH enrollment into H1 surpassed the CASS study as the largest comparison of cardiac surgical and medical approaches to chronic CAD. H1 completed enrollment in May 2007. Published H1 results are anticipated by 2011.

	Appendix E1

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

Study Chair: Jean L. Rouleau, MD

Principal Investigator, Clinical Coordinating Center: Robert H. Jones, MD

Principal Investigator, Data Coordinating Center: Kerry L. Lee, PhD

Director, Global Trial Operations: Eric J. Velazquez, MD

Chair, Core Laboratory Committee: Jae K. Oh, MD

Co-Chair, Surgical Therapy Committee: Robert H. Michler, MD

Co-Chair, Medical Therapy Committee: Christopher M. O’Connor, MD

Program Officer, National Heart, Lung, and Blood Institute: George Sopko, MD

	Appendix E2

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 
Surgical Treatment for Ischemic Heart Failure trial Data and Safety Monitoring Board

Chair: Sidney Goldstein, MD

Felicia Cohn, MD

Kathryn Davis, PhD

Charles Francis, MD

Mark Hlatky, MD

Scott Rankin, MD

Robert Robbins, MD

Barry Zaret, MD

	Appendix E3

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 

Earn CME credits at http://cme.ctsnetjournals.org

 

	Acknowledgments

 
We thank Drs Eugene Braunwald, Myron L. Weisfeldt, and Robert M. Califf for their critical assistance during the initial planning of the STICH trial and Elizabeth E. Schramm for her editorial assistance.

	References

Top Abstract Introduction Materials and Methods Results Discussion Appendix E1 Appendix E2 Appendix E3 References

 

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