Daniel B. Mark, MD, MPH; J. David Knight, MS; Eric J. Velazquez, MD; Jaroslaw Wasilewski, MD, PhD; Jonathan G. Howlett, MD; Peter K. Smith, MD; John A. Spertus, MD, MPH; Miroslaw Rajda, MD; Rakesh Yadav, DM; Baron L. Hamman, MD; Marcin Malinowski, MD; Ajay Naik, MD, DM, DNB; Gena Rankin, MPH; Tina M. Harding, RN, BSN; Laura A. Drew, RN, BSN; Patrice Desvigne-Nickens, MD; Kevin J. Anstrom, PhD
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health.
Acknowledgment: The authors thank the coordinators at the STICH sites that collected data and the patients who agreed to provide their QOL data for this portion of the trial.
Grant Support: By the National Heart, Lung, and Blood Institute and the National Institutes of Health (grant U01 HL69011; Dr. Mark).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-1380.
Reproducible Research Statement:Study protocol and statistical code: Not available. Data set: Will be made available for public access via the National Heart, Lung, and Blood Institute according to National Institutes of Health policy (see www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.htm).
Corresponding Author: Daniel B. Mark, MD, MPH, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715; e-mail, email@example.com.
Current Author Addresses: Drs. Mark, Knight, Velazquez, and Anstrom; Ms. Rankin; Ms. Harding; and Ms. Drew: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.
Dr. Wasilewski: Silesian Center for Heart Diseases, M. Curie-Sklodowskiej 9, 41-800 Zabrze, Poland.
Dr. Howlett: Foothills Medical Center, University of Calgary, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada.
Dr. Smith: Duke University Medical Center, Box 3442, Durham, NC 27710.
Dr. Spertus: Saint Luke's Mid America Heart Institute/University of Missouri–Kansas City, 4401 Wornall Road, Kansas City, MO 64111.
Dr. Rajda: Queen Elizabeth II Health Sciences Centre, Halifax Infimary Site 2261, 1796 Summer Street, Halifax, Nova Scotia B3H 3A7, Canada.
Dr. Yadav: All India Institute of Medical Sciences, Ansari Nagar, New Dehli 110029, India.
Dr. Hamman: Baylor Soltero Cardiovascular Research Center, 621 North Hall Street, Suite 500, Dallas, TX 75226.
Dr. Malinowski: 2nd Department of Cardiac Surgery, Medical University of Silesia, Ziolowa 47, 40-635 Katowice, Poland.
Dr. Naik: Care Institute of Medical Sciences, Science City Road, Sola, Near Shukan Mall, Room 17, Ahmedabad 380060, Gujarat, India.
Dr. Desvigne-Nickens: Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Two Rockledge Center, Room 8176, MSC 7956, 6701 Rockledge Drive, Bethesda, MD 20892.
Author Contributions: Conception and design: D.B. Mark, E.J. Velazquez, J.G. Howlett, P.K. Smith, J.A. Spertus.
Analysis and interpretation of the data: D.B. Mark, J.D. Knight, E.J. Velazquez, J. Wasilewski, J.G. Howlett, P.K. Smith, J.A. Spertus, P. Desvigne-Nickens, K.J. Anstrom.
Drafting of the article: D.B. Mark, J. Wasilewski, J.G. Howlett, M. Malinowski.
Critical revision of the article for important intellectual content: D.B. Mark, E.J. Velazquez, J. Wasilewski, J.G. Howlett, J.A. Spertus, R. Yadav, K.J. Anstrom.
Final approval of the article: D.B. Mark, E.J. Velazquez, J. Wasilewski, J.G. Howlett, P.K. Smith, M. Malinowski, P. Desvigne-Nickens, K.J. Anstrom.
Provision of study materials or patients: E.J. Velazquez, P.K. Smith, J.A. Spertus, R. Yadav, B.L. Hamman, A. Naik, G. Rankin, T.M. Harding, L.A. Drew.
Statistical expertise: D.B. Mark, J.D. Knight, K.J. Anstrom.
Obtaining of funding: D.B. Mark, E.J. Velazquez, G. Rankin.
Administrative, technical, or logistic support: E.J. Velazquez, J. Wasilewski, G. Rankin, T.M. Harding, L.A. Drew.
Collection and assembly of data: D.B. Mark, J.D. Knight, E.J. Velazquez, J.G. Howlett, M. Malinowski, A. Naik, G. Rankin, T.M. Harding, L.A. Drew.
Mark DB, Knight JD, Velazquez EJ, Wasilewski J, Howlett JG, Smith PK, et al. Quality-of-Life Outcomes With Coronary Artery Bypass Graft Surgery in Ischemic Left Ventricular Dysfunction: A Randomized Trial. Ann Intern Med. 2014;161:392-399. doi: 10.7326/M13-1380
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Published: Ann Intern Med. 2014;161(6):392-399.
The STICH (Surgical Treatment for Ischemic Heart Failure) trial compared a strategy of routine coronary artery bypass grafting (CABG) with guideline-based medical therapy for patients with ischemic left ventricular dysfunction.
To describe treatment-related quality-of-life (QOL) outcomes, a major prespecified secondary end point in the STICH trial.
Randomized trial. (ClinicalTrials.gov: NCT00023595)
99 clinical sites in 22 countries.
1212 patients with a left ventricular ejection fraction of 0.35 or less and coronary artery disease.
Random assignment to medical therapy alone (602 patients) or medical therapy plus CABG (610 patients).
A battery of QOL instruments at baseline (98.9% complete) and 4, 12, 24, and 36 months after randomization (collection rates were 80% to 89% of those eligible). The principal prespecified QOL measure was the Kansas City Cardiomyopathy Questionnaire, which assesses the effect of heart failure on patients’ symptoms, physical function, social limitations, and QOL.
The Kansas City Cardiomyopathy Questionnaire overall summary score was consistently higher (more favorable) in the CABG group than in the medical therapy group by 4.4 points (95% CI, 1.8 to 7.0 points) at 4 months, 5.8 points (CI, 3.1 to 8.6 points) at 12 months, 4.1 points (CI, 1.2 to 7.1 points) at 24 months, and 3.2 points (CI, 0.2 to 6.3 points) at 36 months. Sensitivity analyses to account for the effect of mortality on follow-up QOL measurement were consistent with the primary findings.
Therapy was not masked.
In this cohort of symptomatic high-risk patients with ischemic left ventricular dysfunction and multivessel coronary artery disease, CABG plus medical therapy produced clinically important improvements in quality of life compared with medical therapy alone over 36 months.
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