STICH

Surgical Treatment for Ischemic Heart Failure

ClinicalTrials.gov: NCT00023595

Patient Population:

  • heart failure
  • LVEF of 0.35 or less
  • coronary artery disease

Trial Design: 2 international, randomized clincal trials testing 2 related hypotheses

Intervention: coronary artery bypass grafting, CABG with surgical ventricular reconstruction, or medical therapy

Primary Endpoint: survival, survival free of hospitalization

Sponsors: NIH, NHLBI

Quality of Life Substudy

Principal Investigator:
Daniel B. Mark, MD

Primary QOL Measures:

  • Kansas City Cardiomyopathy Questionnaire

Other QOL Measures:

  • Seattle Angina Questionnaire
  • SF-36
  • CES-D Depression Scale
  • Cardiac Self-Efficacy Questionnaire
  • EQ-5D

STICH: QUALITY OF LIFE STUDIES

Overview

This trial examined surgical ventricular reconstruction used in conjunction with coronary artery bypass graft surgery to improve left ventricular function and clinical outcomes in selected patients with ischemic heart failure.

Results of the Surgical Revascularization Hypothesis

Hypothesis 1 tested the myocardial revascularization hypothesis that improvement in myocardial perfusion by coronary bypass graft surgery (CABG) combined with intensive medical therapy (MED) improves long-term survival compared to MED alone (1,212 patients randomized 1:1 to continuing MED with or without CABG). Upon randomization, patients underwent a battery of baseline and follow-up testing overseen by 5 core laboratories for echocardiography, radionuclide myocardial perfusion and viability, cardiac magnetic resonance imaging, neurohormonal-cytokine-genetic blood testing, and economics and quality of life. The 5-year follow-up results published in 2011 showed that there was no significant difference between MED alone and MED plus CABG with respect to the primary endpoint of death from any cause. Patients assigned to CABG, as compared with those assigned to MED alone, had lower rates of death from cardiovascular causes and of death from any cause or hospitalization for cardiovascular causes.

Ann Intern Med. 2014 Sep 16;161(6):392-9. doi: 10.7326/M13-1380.

Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial.

Mark DB, Knight JD, Velazquez EJ, Wasilewski J, Howlett JG, Smith PK, Spertus JA, Rajda M, Yadav R, Hamman BL, Malinowski M, Naik A, Rankin G, Harding TM, Drew LA, Desvigne-Nickens P, Anstrom KJ.

OPEN ACCESS from PubMed Central

Abstract

BACKGROUND:

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.

OBJECTIVE:

To describe treatment-related quality-of-life (QOL) outcomes, a major prespecified secondary end point in the STICH trial.

DESIGN:

Randomized trial. (ClinicalTrials.gov: NCT00023595).

SETTING:

99 clinical sites in 22 countries.

PATIENTS:

1212 patients with a left ventricular ejection fraction of 0.35 or less and coronary artery disease.

INTERVENTION:

Random assignment to medical therapy alone (602 patients) or medical therapy plus CABG (610 patients).

MEASUREMENTS:

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.

RESULTS:

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.

LIMITATION:

Therapy was not masked.

CONCLUSION:

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.

Results of the Left Ventricular Reconstruction Hypothesis

Hypothesis 2 tested the hypothesis that surgical ventricular reconstruction (SVR) to a more normal LV size combined with CABG improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone in patients who require CABG (1,000 patients randomized 1:1 to CABG with or without SVR). The results published in 2009 showed that adding SVR to CABG reduced the LV volume, as compared with CABG alone. However, this anatomical change was not associated with a greater improvement in symptoms, or exercise tolerance, or with a reduction in the rate of death or hospitalization for cardiac causes.

Am Heart J. 2009 May;157(5):837-44, 844.e1-3. doi: 10.1016/j.ahj.2009.03.008. Epub 2009 Apr 1.

Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial.

Mark DB1, Knight JD, Velazquez EJ, Howlett JG, Spertus JA, Djokovic LT, Harding TM, Rankin GR, Drew LA, Szygula-Jurkiewicz B, Adlbrecht C, Anstrom KJ; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators.

OPEN ACCESS from PubMed Central

Abstract

BACKGROUND:

Surgical ventricular reconstruction (SVR) is used in conjunction with coronary artery bypass graft surgery (CABG) to improve left ventricular function and clinical outcomes in selected patients with ischemic heart failure. The impact of SVR on quality of life (QOL) and medical costs is unknown.

METHODS:

We compared CABG plus SVR with CABG alone in 1,000 patients with ischemic heart failure, an anterior wall scar, and a left ventricular ejection fraction <or=0.35. In 991 (99% of eligible), we collected a battery of QOL instruments. The principal, prespecified QOL measure was the Kansas City Cardiomyopathy Questionnaire, which evaluates the effects of heart failure symptoms on QOL using a scale from 0 to 100 with higher scores indicating better QOL. Structured QOL interviews were conducted at baseline, 4, 12, 24, and 36 months post randomization and were >or=92% complete. Cost data were collected on 196 (98%) of 200 patients enrolled in the United States.

RESULTS:

Heart-failure-related QOL outcomes did not differ between the 2 treatment strategies out to 3 years (median Kansas City Cardiomyopathy Questionnaire scores for CABG alone and CABG plus SVR, respectively: baseline 53 versus 54, P = .53; 3 years 85 versus 84, P = .89). There were no treatment-related differences in other QOL measures. In the US patients, total index hospitalization costs averaged over $14,500 higher for CABG plus SVR (P = .004) due primarily to 4.2 extra postoperative, high-intensity care days in the hospital.

CONCLUSIONS:

Addition of SVR to CABG in patients with ischemic heart failure did not improve QOL but significantly increased health care costs.

STICH Publications

Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial.

Mark DB, Knight JD, Velazquez EJ, Wasilewski J, Howlett JG, Smith PK, Spertus JA, Rajda M, Yadav R, Hamman BL, Malinowski M, Naik A, Rankin G, Harding TM, Drew LA, Desvigne-Nickens P, Anstrom KJ.

Ann Intern Med. 2014 Sep 16;161(6):392-9. doi: 10.7326/M13-1380.

PMID: 25222386 Free PMC Article

Exercise capacity and mortality in patients with ischemic left ventricular dysfunction randomized to coronary artery bypass graft surgery or medical therapy: an analysis from the STICH trial (Surgical Treatment for Ischemic Heart Failure).

Stewart RA, Szalewska D, She L, Lee KL, Drazner MH, Lubiszewska B, Kosevic D, Ruengsakulrach P, Nicolau JC, Coutu B, Choudhary SK, Mark DB, Cleland JG, Piña IL, Velazquez EJ, Rynkiewicz A, White H.

JACC Heart Fail. 2014 Aug;2(4):335-43. doi: 10.1016/j.jchf.2014.02.009.

PMID: 25023813 Free PMC Article

Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial.

Mark DB, Knight JD, Velazquez EJ, Howlett JG, Spertus JA, Djokovic LT, Harding TM, Rankin GR, Drew LA, Szygula-Jurkiewicz B, Adlbrecht C, Anstrom KJ; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators..

Am Heart J. 2009 May;157(5):837-44, 844.e1-3. doi: 10.1016/j.ahj.2009.03.008.

PMID: 19376309 Free PMC Article

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

Velazquez EJ, Lee KL, O’Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators..

J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7.

PMID: 18023680 Free PMC Article