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CLINICAL RESEARCH: CARDIAC SURGERY

Clinical Characteristics of Patients Undergoing Surgical Ventricular Reconstruction by Choice and by Randomization

Marian Zembala, MD^_*, Robert E. Michler, MD, Andrzej Rynkiewicz, MD, Thao Huynh, MD, Lilin She^||, Barbara Lubiszewska, MD^¶, James A. Hill, MD^#, Ruzena Jandova, MD^_**, Francois Dagenais, MD, Eric D. Peterson, MD, MPH and Robert H. Jones, MD^,_*

^_* Department of Cardiac Surgery and Transplantation, Silesian Center for Heart Diseases/Medical University of Silesia, Zabrze-Katowice, Poland
Department of Cardiothoracic Surgery and Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York
Medical University of Gdansk, Gdansk, Poland
McGill University, Montreal, Quebec, Canada
^|| Duke Clinical Research Institute, Durham, North Carolina
^¶ National Institute of Cardiology, Warsaw, Poland
^# Division of Cardiovascular Medicine, University of Florida College of Medicine, Shands Hospital, Gainesville, Florida
^_** Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Institut Universitaire de Cardiologie de Quebec, Laval Hospital, Quebec, Quebec, Canada
Division of Cardiovascular Medicine/Department of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
Division of Cardiothoracic Surgery/Department of Surgery, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina

Manuscript received August 19, 2009; revised manuscript received February 3, 2010, accepted March 2, 2010.

^_* 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 confirm the generalizability of the conclusions of the STICH (Surgical Treatment for Ischemic Heart Failure) trial.

Background: Surgical ventricular reconstruction (SVR) added to coronary artery bypass grafting (CABG) did not decrease death or cardiac hospitalization in STICH patients randomized to CABG with (n = 501) or without (n = 499) SVR.

Methods: Baseline clinical characteristics of 1,000 STICH SVR hypothesis patients and 1,036 STICH-eligible Society of Thoracic Surgeons (STS) National Cardiac Database patients undergoing CABG plus SVR were entered into a multivariate model equation to predict a mortality that placed these 2,036 patients in 1 of 32 risk at randomization (RAR) groups. The number of patients in each RAR group profiled the risk of STICH treatment arms and of STICH and STS STICH-eligible patients.

Results: That 85% of the 1,000 STICH patients known to have no significant differences in baseline characteristics between the 2 treatment arms shared the same RAR group suggests that the RAR methodology has sufficient accuracy to compare RAR profiles of STICH and STS patients. RAR group was shared by 1,522 of 2,036 STICH and STS STICH-eligible patients (75%) who underwent CABG plus SVR. Differences in baseline characteristics responsible for more low-risk STICH patients and more high-risk STS patients were modest. Cox proportional hazard ratios of 1,000 STICH patients in 3 RAR groups suggested by STICH and STS RAR differences showed no differential treatment effect on survival across the low-, intermediate-, and high-risk groups.

Conclusions: The STICH conclusion of no benefit from adding SVR to CABG applies to a broad spectrum of CABG-eligible patients with ischemic cardiomyopathy. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease; NCT00023595)

Key Words: surgical ventricular reconstruction • randomized clinical trial • mortality prediction • ischemic cardiomyopathy

Abbreviations and Acronyms   CABG = coronary artery bypass grafting   DDCD = Duke Databank for Cardiovascular Diseases   LV = left ventricular   LVEF = left ventricular ejection fraction   RAR = risk at randomization   STS = Society of Thoracic Surgeons   SVR = surgical ventricular reconstruction

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