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The medicine, angioplasty, or surgery study: a randomized controlled clinical trial of three therapeutic strategies for multi-vessel coronary artery disease
ISRCTN ISRCTN66068876
DOI 10.1186/ISRCTN66068876
ClinicalTrials.gov identifier
EudraCT number
Public title The medicine, angioplasty, or surgery study: a randomized controlled clinical trial of three therapeutic strategies for multi-vessel coronary artery disease
Scientific title
Acronym MASS II
Serial number at source 946/94/056
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.
Lay summary Not provided at time of registration
Ethics approval Institutional Review Board (IRB), Brazil, 08/08/1994
Study design Randomized controlled comparative study
Countries of recruitment Brazil
Disease/condition/study domain Coronary Artery Disease (CAD)
Participants - inclusion criteria 1. Stable angina
2. Preserved left ventricular function
3. Two or three vessel disease
Participants - 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
Anticipated start date 10/06/1994
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material
Target number of participants 611
Interventions 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.
Primary outcome measure(s) 1. Non-fatal myocardial infarction
2. Cardiac death
3. Refractory angina requiring revascularization
Secondary outcome measure(s) 1. Quality of life
2. Cost comparison
3. Cerebro-Vascular Accident (CVA)
Sources of funding Zerbini Foundation (Brazil)
Trial website http://www.incor.usp.br
Publications 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
Contact name Prof  Whady  Hueb
  Address 44 Dr. Eneas Carvalho Aguiar avenue
AB sala 114
  City/town Sao Paulo
  Zip/Postcode 05403-000
  Country Brazil
Sponsor Zerbini Foundation (Brazil)
  Address Fundação Zerbini
Clinical Research Office
Av. Brig. Faria Lima
1.884 - 2º Andar
  City/town Sao Paulo
  Zip/Postcode 01451-000
  Country Brazil
  Sponsor website: http://www.zerbini.org.br
Date applied 06/02/2006
Last edited 18/06/2014
Date ISRCTN assigned 27/07/2006
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