Condition category
Circulatory System
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
17/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.stichtrial.org/

Contact information

Type

Scientific

Primary contact

Mr Mike Lammiman

ORCID ID

Contact details

Department of Cardiology
Castle Road
Cottingham
HU16 5JQ
United Kingdom
mike.lammiman@hey.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00023595

Protocol/serial number

5148

Study information

Scientific title

Surgical Treatment for Ischaemic Heart Failure Trial (STICH): a multicentre randomised interventional treatment trial

Acronym

Study hypothesis

No randomised trial has ever directly compared long-term benefits of surgical and medical treatment of patients with ischaemic heart failure (HF). Along the broad spectrum of severity of ischaemic HF, specific clinical information, such as severe angina or left main coronary artery stenosis, may clearly indicate the need for surgical therapy for some patients.

However, a large number of patients fall into a gray zone without clear evidence for benefit from either medical or surgical therapy. For these patients, evidence supporting choice between therapies was never strong and has only been confused by recent studies showing improved outcomes with both therapies.

Patients for whom equipoise of anticipated benefit now exists between modern medical and surgical therapy represent the broad population who are appropriate candidates for a randomised trial to provide the context for assessing the value of two therapeutic strategies:
1. Medication (MED) alone
2. MED and coronary artery bypass grafting (CABG)

The study is also being run in the USA and includes surgical ventricular reconstruction as a treatment option in those sites only.

As of 13/07/2010 the study is seeking a protocol amendment to extend follow-up for another 9 years.

Ethics approval

Hull and East Riding REC, 04/08/2005, ref: 05/MRE00/51

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

1. Optical medication (for heart failure according to National Institute for Clinical Excellence [NICE] guidelines)
2. CABG and optimal medication

Total duration of treatment: up to 6 years maximum
Follow-up length: 36 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

CABG combined with MED compared to MED alone, measured up to 6 years.

Secondary outcome measures

Measured up to 6 years:
1. Cardiac magnetic resonance (CMR) of left ventricle (LV) shape, size and function for predicting the benefit of a specific treatment strategy
2. Nuclear cardiology and/or echocardiography testing of myocardial ischaemia

Overall trial start date

22/12/2005

Overall trial end date

30/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men
2. Women who are not of childbearing potential
3. Aged 18 years or above
4. Who have a left ventricular ejection fraction (LVEF) less than 0.35 measured by cardiac magnetic resonance (CMR) ventriculogram, gated single photon emission computed tomography (SPECT) ventriculogram, echocardiography, or contrast ventriculogram within three months of trial entry
5. Who have coronary artery disease suitable for revascularisation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 2800

Participant exclusion criteria

1. Failure to provide informed consent
2. Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement
3. Cardiogenic shock (within 72 hours of randomization) as defined by the need for intra-aortic balloon support or the requirement for intravenous inotropic support
4. Plan for percutaneous intervention of coronary artery disease
5. Recent acute myocardial infarction judged to be an important cause of left ventricular dysfunction
6. History of more than one prior coronary bypass operation
7. Non-cardiac illness with a life expectancy of less than 3 years
8. Non-cardiac illness imposing substantial operative mortality
9. Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode)
10. Previous heart, kidney, liver, or lung transplantation
11. Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device

MED Therapy Eligibility Criteria:
12. Absence of left main coronary artery disease as defined by an intraluminal stenosis of 50% or greater
13. Absence of Canadian Class III angina or greater (angina markedly limiting ordinary activity)

Recruitment start date

22/12/2005

Recruitment end date

30/05/2007

Locations

Countries of recruitment

United Kingdom, United States of America

Trial participating centre

Department of Cardiology
Cottingham
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Duke University (USA)

Sponsor details

School of Medicine
Durham
NC 27710
United States of America

Sponsor type

University/education

Website

http://www.duke.edu/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

National Institutes of Health (NIH) (USA) - National Heart, Blood and Lung Institute (ref: 5 U01 HL069015-4)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18023680
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19329820
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19376309
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20670760
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20670761
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21463153
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21463150
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22227341
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22553307
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23111018
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22584648
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23515275
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23500234
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24035166
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24251115
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24621972
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25023813

Publication citations

  1. Protocol

    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, , The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial., J. Thorac. Cardiovasc. Surg., 2007, 134, 6, 1540-1547, doi: 10.1016/j.jtcvs.2007.05.069.

  2. Results

    Jones RH, Velazquez EJ, Michler RE, Sopko G, Oh JK, O'Connor CM, Hill JA, Menicanti L, Sadowski Z, Desvigne-Nickens P, Rouleau JL, Lee KL, , Coronary bypass surgery with or without surgical ventricular reconstruction., N. Engl. J. Med., 2009, 360, 17, 1705-1717, doi: 10.1056/NEJMoa0900559.

  3. Results

    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, , Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial., Am. Heart J., 2009, 157, 5, 837-44, 844.e1-3, doi: 10.1016/j.ahj.2009.03.008.

  4. Results

    Jones RH, White H, Velazquez EJ, Shaw LK, Pietrobon R, Panza JA, Bonow RO, Sopko G, O'Connor CM, Rouleau JL, STICH (Surgical Treatment for Ischemic Heart Failure) trial enrollment., J. Am. Coll. Cardiol., 2010, 56, 6, 490-498, doi: 10.1016/j.jacc.2009.11.102.

  5. Results

    Zembala M, Michler RE, Rynkiewicz A, Huynh T, She L, Lubiszewska B, Hill JA, Jandova R, Dagenais F, Peterson ED, Jones RH, Clinical characteristics of patients undergoing surgical ventricular reconstruction by choice and by randomization., J. Am. Coll. Cardiol., 2010, 56, 6, 499-507, doi: 10.1016/j.jacc.2010.03.054.

  6. Results

    Bonow RO, Maurer G, Lee KL, Holly TA, Binkley PF, Desvigne-Nickens P, Drozdz J, Farsky PS, Feldman AM, Doenst T, Michler RE, Berman DS, Nicolau JC, Pellikka PA, Wrobel K, Alotti N, Asch FM, Favaloro LE, She L, Velazquez EJ, Jones RH, Panza JA, , Myocardial viability and survival in ischemic left ventricular dysfunction., N. Engl. J. Med., 2011, 364, 17, 1617-1625, doi: 10.1056/NEJMoa1100358.

  7. Results

    Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko A, Ali IS, Pohost G, Gradinac S, Abraham WT, Yii M, Prabhakaran D, Szwed H, Ferrazzi P, Petrie MC, O'Connor CM, Panchavinnin P, She L, Bonow RO, Rankin GR, Jones RH, Rouleau JL, , Coronary-artery bypass surgery in patients with left ventricular dysfunction., N. Engl. J. Med., 2011, 364, 17, 1607-1616, doi: 10.1056/NEJMoa1100356.

  8. Results

    Oh JK, Pellikka PA, Panza JA, Biernat J, Attisano T, Manahan BG, Wiste HJ, Lin G, Lee K, Miller FA, Stevens S, Sopko G, She L, Velazquez EJ, , Core lab analysis of baseline echocardiographic studies in the STICH trial and recommendation for use of echocardiography in future clinical trials., J Am Soc Echocardiogr, 2012, 25, 3, 327-336, doi: 10.1016/j.echo.2011.12.002.

  9. Results

    Deja MA, Grayburn PA, Sun B, Rao V, She L, Krejca M, Jain AR, Leng Chua Y, Daly R, Senni M, Mokrzycki K, Menicanti L, Oh JK, Michler R, Wróbel K, Lamy A, Velazquez EJ, Lee KL, Jones RH, Influence of mitral regurgitation repair on survival in the surgical treatment for ischemic heart failure trial., Circulation, 2012, 125, 21, 2639-2648, doi: 10.1161/CIRCULATIONAHA.111.072256.

  10. Results

    Michler RE, Rouleau JL, Al-Khalidi HR, Bonow RO, Pellikka PA, Pohost GM, Holly TA, Oh JK, Dagenais F, Milano C, Wrobel K, Pirk J, Ali IS, Jones RH, Velazquez EJ, Lee KL, Di Donato M, , Insights from the STICH trial: change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction., J. Thorac. Cardiovasc. Surg., 2013, 146, 5, 1139-1145.e6, doi: 10.1016/j.jtcvs.2012.09.007.

  11. Results

    Oh JK, Velazquez EJ, Menicanti L, Pohost GM, Bonow RO, Lin G, Hellkamp AS, Ferrazzi P, Wos S, Rao V, Berman D, Bochenek A, Cherniavsky A, Rogowski J, Rouleau JL, Lee KL, , Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy., Eur. Heart J., 2013, 34, 1, 39-47, doi: 10.1093/eurheartj/ehs021.

  12. Results

    Doenst T, Cleland JG, Rouleau JL, She L, Wos S, Ohman EM, Krzeminska-Pakula M, Airan B, Jones RH, Siepe M, Sopko G, Velazquez EJ, Racine N, Gullestad L, Filgueira JL, Lee KL, , Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease., Circ Heart Fail, 2013, 6, 3, 443-450, doi: 10.1161/CIRCHEARTFAILURE.112.000130.

  13. Results

    Panza JA, Holly TA, Asch FM, She L, Pellikka PA, Velazquez EJ, Lee KL, Borges-Neto S, Farsky PS, Jones RH, Berman DS, Bonow RO, Inducible myocardial ischemia and outcomes in patients with coronary artery disease and left ventricular dysfunction., J. Am. Coll. Cardiol., 2013, 61, 18, 1860-1870, doi: 10.1016/j.jacc.2013.02.014.

  14. Results

    Golba K, Mokrzycki K, Drozdz J, Cherniavsky A, Wrobel K, Roberts BJ, Haddad H, Maurer G, Yii M, Asch FM, Handschumacher MD, Holly TA, Przybylski R, Kron I, Schaff H, Aston S, Horton J, Lee KL, Velazquez EJ, Grayburn PA, , Mechanisms of functional mitral regurgitation in ischemic cardiomyopathy determined by transesophageal echocardiography (from the Surgical Treatment for Ischemic Heart Failure Trial)., Am. J. Cardiol., 2013, 112, 11, 1812-1818, doi: 10.1016/j.amjcard.2013.07.047.

  15. Results

    Carson P, Wertheimer J, Miller A, O'Connor CM, Pina IL, Selzman C, Sueta C, She L, Greene D, Lee KL, Jones RH, Velazquez EJ, , The STICH trial (Surgical Treatment for Ischemic Heart Failure): mode-of-death results., JACC Heart Fail, 2013, 1, 5, 400-408, doi: 10.1016/j.jchf.2013.04.012.

  16. Results

    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, 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)., JACC Heart Fail, 2014, 2, 4, 335-343, doi: 10.1016/j.jchf.2014.02.009.

Additional files

Editorial Notes