Condition category
Circulatory System
Date applied
21/02/2008
Date assigned
10/03/2008
Last edited
07/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Whady Hueb

ORCID ID

Contact details

Av. Dr. Eneas Carvalho Aguiar 44 AB
Sala 114
Sao Paulo
05403000
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1926/01/114

Study information

Scientific title

A randomised comparative study of patients undergoing myocardial revascularisation with or without cardiopulmonary bypass surgery

Acronym

MASS III

Study hypothesis

The aim of the MASS III Trial is to compare medical effectiveness, safety, cerebral injury, quality of life, cost-effectiveness of coronary surgery with (on-pump) or without (off-pump) cardiopulmonary bypass.

Ethics approval

Institutional Review Board (Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq) approved on 19/10/2001.

Study design

Randomised controlled comparative trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Coronary artery disease

Intervention

Trial operators were required to perform optimum coronary revascularisation in accordance with the current best practices. The surgery was performed by physicians experienced in both on-pump and off-pump bypass surgery techniques. Surgical access to the heart was through a standard median sternotomy in all cases. All incisions and closure techniques were the same for both groups, limiting variability and maintaining blinding of group assignment for patients, family and cardiologists. A cell saver reservoir (COBE Cardiovascular, Inc., USA) was spun down and returned to all patients when the quantity was sufficient.

Off-pump strategies: Off-pump surgery used the Octopus stabiliser described in detail elsewhere. In brief, the distal ends of the two suction arms of the stabiliser are placed on the beating heart on both sides of the target coronary artery. The proximal parts are fixed to the operating table. Through the application of negative pressure, the target area of the heart is sufficiently immobilised to allow the safe construction of the anastomosis of the graft with the recipient artery.

On-pump technique: Conventional coronary artery surgery with cardiopulmonary bypass was accomplished with every effort to minimize the impact of cardiopulmonary bypass. Patients without diabetes received 1 gram of hydrocortisone sodium succinate (SoluCortef®, Pharmacia & Upjohn Co., USA) intravenously before of anesthesia. This procedure will be made only in the on-pump technique.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be assessed at discharge and 5-year follow-up:
1. Incidence of cardiovascular mortality
2. Cerebrovascular accident
3. Non-fatal myocardial infarction
4. Refractory angina requiring revascularisation

Secondary outcome measures

The following were assessed at discharge and at 5-year follow-up:
1. Non-cardiac mortality
2. Presence and severity of angina
3. Quality of life, using the 36-item Short Form health survey (SF-36)
4. Cost-effectiveness

Overall trial start date

31/01/2002

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, age 18 years or older
2. Patients with stable angina pectoris and/or documented ischemia due to multivessel disease and preserved ventricular function
3. Angiographically confirmed multivessel coronary artery disease (CAD) with >=70% lesions in at least two major epicardial vessels and at least two separate coronary artery territories (LAD, LCX and RCA)
4. Patients who are eligible for coronary surgery both with and without cardiopulmonary bypass circuit
5. Willing to comply with all follow-up study visits
6. Signed and received a copy of the informed consent

Note: Non-significant left main stenoses can be included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

311

Participant exclusion criteria

1. Age under 18 years
2. Severe congestive hearth failure, New York Heart Association (NYHA) Class III or IV, or pulmonary edema
3. Prior valve replacement or coronary artery bypass graft (CABG) surgery
4. Prior percutaneous coronary intervention (PCI) with stent implantation within 6 months
5. Prior stroke within 6 months or patients with stroke that occurred more than 6 months ago with significant residual neurological involvement, as reflected in a Rankin score >= 1
6. Need for concomitant major surgery e.g. valve replacement, resection ventricular aneurysm, congenital heart disease vascular surgery of the carotid artery, or thoracic-abdominal aorta
7. Concomitant medical disorders making clinical follow-up at least 5 years unlikely or impossible e.g. neoplastic, hepatic, or other severe disease
8. Q-wave myocardial infarction in the previous 6 weeks
9. Hemorrhagic diathesis or hypercoagulability
10. Thoracic deformations technically precluding surgery without extracorporeal circulation
11. Unable to give informed consent

Recruitment start date

31/01/2002

Recruitment end date

31/01/2010

Locations

Countries of recruitment

Brazil

Trial participating centre

Av. Dr. Eneas Carvalho Aguiar 44 AB
Sao Paulo
05403000
Brazil

Sponsor information

Organisation

Zerbini Foundation (Fundação Zerbini) (Brazil)

Sponsor details

Av. Dr. Eneas Carvalho Aguiar 44 AB
Sala 114
Sao Paulo
05403-000
Brazil

Sponsor type

Charity

Website

http://www.incor.usp.br

Funders

Funder type

Charity

Funder name

Zerbini Foundation (Fundaciao Zerbini) (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24855193
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25096030

Publication citations

  1. Results

    Vieira de Melo RM, Hueb W, Rezende PC, Alves da Costa LM, Oikawa FT, Lima EG, Hueb AC, Scudeler TL, Kalil Filho R, Comparison between off-pump and on-pump coronary artery bypass grafting in patients with severe lesions at the circumflex artery territory: 5-year follow-up of the MASS III trial., Eur J Cardiothorac Surg, 2014, doi: 10.1093/ejcts/ezu216.

  2. Results

    Vieira de Melo RM, Hueb W, Rezende PC, Lima EG, Hueb AC, Ramires JA, Filho RK, On-pump versus off-pump coronary artery bypass surgery in patients older than 60 years: five-year follow-up of MASS III trial., J Cardiothorac Surg, 2014, 9, 136, doi: 10.1186/1749-8090-9-136.

Additional files

Editorial Notes