Condition category
Circulatory System
Date applied
06/02/2006
Date assigned
27/07/2006
Last edited
18/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.incor.usp.br

Contact information

Type

Scientific

Primary contact

Prof Whady Hueb

ORCID ID

Contact details

44 Dr. Eneas Carvalho Aguiar avenue
AB sala 114
Sao Paulo
05403-000
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

946/94/056

Study information

Scientific title

Acronym

MASS II

Study hypothesis

To evaluate the relative efficacies of the possible therapeutic strategies for patients with multi-vessel Coronary Artery Disease (CAD), stable angina, and preserved ventricular function.

Ethics approval

Institutional Review Board (IRB), Brazil, 08/08/1994

Study design

Randomized controlled comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coronary Artery Disease (CAD)

Intervention

In this trial, all patients were placed on an optimal medical regiment consisting of a stepped-care approach using nitrates, aspirin, beta-blockers, calcium channel blockers, Angiotensin Converting Enzyme (ACE) inhibitors or a combination of these drugs, unless contraindicated. 3-Hydroxy-3-Methyl Glutaryl CoA (HMG-CoA) reductase inhibitors were also prescribed along with a low-fat diet on an individual basis. The medications were provided free by the Heart Institute.

Patients were then randomized into three groups to continue with aggressive medical therapy alone or to undergo PCI or CABG concurrent with the medical treatment.

Trial operators were required to do optimum coronary revascularization in accordance with current best practice. Equivalent revascularization was encouraged but was not mandatory.

For patients assigned to have PCI, the procedure was available within three weeks after the assignment. Devices used for catheter-based therapeutic strategies, including stents, lasers, directional atherectomy and balloon angioplasty, were available to the interventionist. Angioplasty was performed according to a standard protocol. Successful revascularization in the PCI group was defined as a residual stenosis of less than 50% reduction in luminal diameter with Thrombolysis in Myocardial Infarction (TIMI) grade flow three.

Patients assigned to the CABG group underwent the operation within 12 weeks after assignment. Complete revascularization was accomplished if technically feasible with saphenous vein grafts, internal mammary arteries and other conduits such as radial or gastroepiploic arteries. Standard surgical techniques were used under hypothermic arrest with blood cardioplegia. No off-pump CABG was performed.

Intervention type

Drug

Phase

Not Applicable

Drug names

Nitrates, aspirin, beta-blockers, calcium channel blockers, Angiotensin Converting Enzyme (ACE) inhibitors and 3-Hydroxy-3-Methyl Glutaryl CoA (HMG-CoA) reductase inhibitors

Primary outcome measures

1. Non-fatal myocardial infarction
2. Cardiac death
3. Refractory angina requiring revascularization

Secondary outcome measures

1. Quality of life
2. Cost comparison
3. Cerebro-Vascular Accident (CVA)

Overall trial start date

10/06/1994

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stable angina
2. Preserved left ventricular function
3. Two or three vessel disease

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

611

Participant exclusion criteria

1. Unstable angina or acute myocardial infarction requiring emergency revascularization
2. Ventricular aneurism requiring surgical repair
3. Left ventricular ejection fraction of less than 40%
4. A history of Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) and single vessel disease
5. A history of congenital heart disease
6. Valvular heart disease or cardiomyopathy
7. Inability to understand or cooperate with the protocol requirements or return for follow-up
8. Left main coronary artery stenosis of 50% or more
9. Suspected or known pregnancy
10. Other coexisting condition that was a contraindication to CABG or PCI

Recruitment start date

10/06/1994

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Brazil

Trial participating centre

44 Dr. Eneas Carvalho Aguiar avenue
Sao Paulo
05403-000
Brazil

Sponsor information

Organisation

Zerbini Foundation (Brazil)

Sponsor details

Fundação Zerbini
Clinical Research Office
Av. Brig. Faria Lima
1.884 - 2º Andar
Sao Paulo
01451-000
Brazil

Sponsor type

Charity

Website

http://www.zerbini.org.br

Funders

Funder type

Charity

Funder name

Zerbini Foundation (Brazil)

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

1. 2003 results in: http://www.ncbi.nlm.nih.gov/pubmed/12970202
2. 2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15145093
3. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17339572
4. 2009 results on the association of chronic kidney dysfunction in patients with multivessel chronic coronary artery disease in http://www.ncbi.nlm.nih.gov/pubmed/19464462
5. 2009 results on the association of TCF7L2 polymorphism rs7903146 and coronary artery disease severity and mortality in http://www.ncbi.nlm.nih.gov/pubmed/19924244
6. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20837925
7. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20733102
8. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21283728
9. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22965977
10. 2012 cost analysis in: http://www.ncbi.nlm.nih.gov/pubmed/22965975
11. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23895807
12. 2013 ten-year results in: http://www.ncbi.nlm.nih.gov/pubmed/22944095
13. 2013 10-year follow-up results in: http://www.ncbi.nlm.nih.gov/pubmed/23828828

Publication citations

  1. Results

    Favarato D, Hueb W, Gersh BJ, Soares PR, Cesar LA, da Luz PL, Oliveira SA, Ramires JA, , Relative cost comparison of treatments for coronary artery disease: the First Year Follow-Up of MASS II Study., Circulation, 2003, 108 Suppl 1, II21-3, doi: 10.1161/01.cir.0000087381.98299.7b.

  2. Results

    Hueb W, Soares PR, Gersh BJ, César LA, Luz PL, Puig LB, Martinez EM, Oliveira SA, Ramires JA, The medicine, angioplasty, or surgery study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results., J. Am. Coll. Cardiol., 2004, 43, 10, 1743-1751, doi: 10.1016/j.jacc.2003.08.065.

  3. Results

    Gurfinkel EP, Lernoud VS, Laguens RP, Favaloro RR, Advances in coronary heart disease surgery in Latin America., Circulation, 2007, 115, 9, 1147-1153, doi: 10.1161/CIRCULATIONAHA.106.623595.

  4. Results on the association of chronic kidney dysfunction in patients with multivessel chronic coronary artery disease

    Lopes NH, da Silva Paulitsch F, Pereira A, Garzillo CL, Ferreira JF, Stolf N, Hueb W, Mild chronic kidney dysfunction and treatment strategies for stable coronary artery disease., J. Thorac. Cardiovasc. Surg., 2009, 137, 6, 1443-1449, doi: 10.1016/j.jtcvs.2008.11.028.

  5. Results

    Hueb W, Lopes NH, Pereira AC, Hueb AC, Soares PR, Favarato D, Vieira RD, Lima EG, Garzillo CL, Paulitch Fda S, César LA, Gersh BJ, Ramires JA, Five-year follow-up of a randomized comparison between off-pump and on-pump stable multivessel coronary artery bypass grafting. The MASS III Trial., Circulation, 2010, 122, 11 Suppl, S48-52, doi: 10.1161/CIRCULATIONAHA.109.924258.

  6. Results

    Hueb W, Lopes N, Gersh BJ, Soares PR, Ribeiro EE, Pereira AC, Favarato D, Rocha AS, Hueb AC, Ramires JA, Ten-year follow-up survival of the Medicine, Angioplasty, or Surgery Study (MASS II): a randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease., Circulation, 2010, 122, 10, 949-957, doi: 10.1161/CIRCULATIONAHA.109.911669.

  7. Results

    Sousa AG, Lopes NH, Hueb WA, Krieger JE, Pereira AC, Genetic variants of diabetes risk and incident cardiovascular events in chronic coronary artery disease., PLoS ONE, 2011, 6, 1, e16341, doi: 10.1371/journal.pone.0016341.

  8. Results

    Vieira RD, Hueb W, Gersh BJ, Lima EG, Pereira AC, Rezende PC, Garzillo CL, Hueb AC, Favarato D, Soares PR, Ramires JA, Kalil Filho R, Effect of complete revascularization on 10-year survival of patients with stable multivessel coronary artery disease: MASS II trial., Circulation, 2012, 126, 11 Suppl 1, S158-63, doi: 10.1161/CIRCULATIONAHA.111.084236.

  9. Cost analysis

    Vieira RD, Hueb W, Hlatky M, Favarato D, Rezende PC, Garzillo CL, Lima EG, Soares PR, Hueb AC, Pereira AC, Ramires JA, Kalil Filho R, Cost-effectiveness analysis for surgical, angioplasty, or medical therapeutics for coronary artery disease: 5-year follow-up of medicine, angioplasty, or surgery study (MASS) II trial., Circulation, 2012, 126, 11 Suppl 1, S145-50, doi: 10.1161/CIRCULATIONAHA.111.084442.

  10. Results

    Lima EG, Hueb W, Garcia RM, Pereira AC, Soares PR, Favarato D, Garzillo CL, D'Oliveira Vieira R, Rezende PC, Takiuti M, Girardi P, Hueb AC, Ramires JA, Kalil Filho R, Impact of diabetes on 10-year outcomes of patients with multivessel coronary artery disease in the Medicine, Angioplasty, or Surgery Study II (MASS II) trial., Am. Heart J., 2013, 166, 2, 250-257, doi: 10.1016/j.ahj.2013.04.017.

  11. Sousa AG, Marquezine GF, Lemos PA, Martinez E, Lopes N, Hueb WA, Krieger JE, Pereira AC, TCF7L2 polymorphism rs7903146 is associated with coronary artery disease severity and mortality., PLoS ONE, 2009, 4, 11, e7697, doi: 10.1371/journal.pone.0007697.

  12. Rezende PC, Hueb W, Garzillo CL, Lima EG, Hueb AC, Ramires JA, Kalil Filho R, Ten-year outcomes of patients randomized to surgery, angioplasty, or medical treatment for stable multivessel coronary disease: effect of age in the Medicine, Angioplasty, or Surgery Study II trial., J. Thorac. Cardiovasc. Surg., 2013, 146, 5, 1105-1112, doi: 10.1016/j.jtcvs.2012.08.015.

  13. Garzillo CL, Hueb W, Gersh BJ, Lima EG, Rezende PC, Hueb AC, Vieira RD, Favarato D, Pereira AC, Soares PR, Serrano CV, Ramires JA, Kalil Filho R, Long-term analysis of left ventricular ejection fraction in patients with stable multivessel coronary disease undergoing medicine, angioplasty or surgery: 10-year follow-up of the MASS II trial., Eur. Heart J., 2013, 34, 43, 3370-3377, doi: 10.1093/eurheartj/eht201.

Additional files

Editorial Notes