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CLINICAL RESEARCH: CARDIAC SURGERY

STICH (Surgical Treatment for Ischemic Heart Failure) Trial Enrollment

Robert H. Jones, MD^_*,_*, Harvey White, MB, ChB, DSc^||, Eric J. Velazquez, MD, Linda K. Shaw, MHS, Ricardo Pietrobon, MD, PhD^,¶, Julio A. Panza, MD^#, Robert O. Bonow, MD^_**, George Sopko, MD, Christopher M. O'Connor, MD and Jean-Lucien Rouleau, MD

^_* Division of Cardiothoracic Surgery/Department of Surgery, Duke University, Durham, North Carolina
Division of Cardiovascular Medicine/Department of Medicine, Duke University, Durham, North Carolina
Department of Surgery, Duke University, Durham, North Carolina
Duke Clinical Research Institute, Durham, North Carolina
^|| Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
^¶ Department of Health Services Research, Duke-NUS, Singapore
^# Department of Medicine-Cardiovascular Disease, Washington Hospital Center, Washington, DC
^_** Division of Cardiology, Northwestern University Feinberg School of Medicine, Northwestern Memorial Hospital, Chicago, Illinois
Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
Institut de Cardiologie de Montreal, University of Montreal, Montreal, Quebec, Canada

Manuscript received February 27, 2009; revised manuscript received October 30, 2009, accepted November 3, 2009.

^_* Reprint requests and correspondence: Dr. Robert H. Jones, Duke University Medical Center, P.O. Box 2986, Durham, North Carolina 27710 (Email: jones060{at}mc.duke.edu).

Objectives: The aim of this study was to assess the influence of enrolling site location and enrollment performance on the generalizability of STICH (Surgical Treatment for Ischemic Heart Failure) trial results.

Background: The international STICH trial seeks to define the role of cardiac surgery for patients with ischemic cardiomyopathy.

Methods: Baseline characteristics of 2,136 randomized STICH patients were entered into a multivariate equation created using the Duke Databank for Cardiovascular Diseases to predict their 5-year risk for death without cardiac surgery. Patients ordered by increasing predicted risk were assigned to 1 of 32 risk at randomization (RAR) groups created to share one-thirty-second of total predicted deaths. Numbers of patients sharing the same RAR group were compared between higher and lower enrolling site groupings and for countries tending to enroll high- or low-risk patients.

Results: Country of enrollment was a stronger determinant of risk diversity than site enrollment performance among patients enrolled at 127 sites in 26 countries. Mean RAR differences among countries ranged from 9.4 (Singapore) to 18.6 (Germany). However, 1,614 of 2,136 patients (76%) from countries enrolling lower-risk patients shared the same RAR group with patients from countries enrolling higher-risk patients. Baseline characteristics responsible for risk differences of patients enrolled in the 2 country groupings were sufficiently similar to exert little influence on clinical decision making.

Conclusions: STICH randomized patients are characterized by a continuous spectrum of risk, without discordant dominance from any site or country. Clinical site diversity promises to enhance the generalization of STICH trial results to a broad population of patients with ischemic cardiomyopathy. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease; NCT00023595)

Key Words: coronary artery bypass grafting • surgical ventricular reconstruction • randomized clinical trial

Abbreviations and Acronyms   CABG = coronary artery bypass grafting   CAD = coronary artery disease   LV = left ventricular   MED = evidence-based medical therapy   RAR = risk at randomization   SVR = surgical ventricular reconstruction

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