The medicine, angioplasty, or surgery study: a randomized controlled clinical trial of three therapeutic strategies for multi-vessel coronary artery disease

ISRCTN	ISRCTN66068876
DOI	https://doi.org/10.1186/ISRCTN66068876
Secondary identifying numbers	946/94/056

Submission date: 06/02/2006
Registration date: 27/07/2006
Last edited: 29/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Whady Hueb
Scientific

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

Study information

Study design	Randomized controlled comparative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The medicine, angioplasty, or surgery study: a randomized controlled clinical trial of three therapeutic strategies for multi-vessel coronary artery disease
Study 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(s)	Institutional Review Board (IRB), Brazil, 08/08/1994
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 measure	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 study start date	10/06/1994
Overall study end date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	611
Total final enrolment	611
Participant inclusion criteria	1. Stable angina 2. Preserved left ventricular function 3. Two or three vessel disease
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

Study participating centre

44 Dr. Eneas Carvalho Aguiar avenue

Sao Paulo
05403-000
Brazil

Sponsor information

Zerbini Foundation (Brazil)
Charity

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

Website	http://www.zerbini.org.br
"ROR"	https://ror.org/003c2h870

Funders

Funder type

Charity

Zerbini Foundation (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/09/2003		Yes	No
Results article	results	19/05/2004		Yes	No
Results article	results	06/03/2007		Yes	No
Results article	results on the association of chronic kidney dysfunction in patients with multivessel chronic coronary artery disease	01/06/2009		Yes	No
Results article	results on the association of TCF7L2 polymorphism rs7903146 and coronary artery disease severity and mortality	17/11/2009		Yes	No
Results article	results	07/09/2010		Yes	No
Results article	results	14/09/2010		Yes	No
Results article	results	20/01/2011		Yes	No
Other publications	cost analysis	11/09/2012		Yes	No
Results article	results	11/09/2012		Yes	No
Results article	results	01/08/2013		Yes	No
Results article	10-year follow-up results	01/11/2013		Yes	No
Results article	10-year results	01/11/2013		Yes	No
Results article	cost-effectiveness results	03/11/2018		Yes	No
Results article	-year follow-up results	01/08/2020	16/12/2020	Yes	No
Results article		22/09/2022	29/09/2022	Yes	No

Editorial Notes

29/09/2022: Publication reference added.
16/12/2020: Publication reference and total final enrolment added.
12/11/2018: Publication reference added.