Study protocol

Rationale, design and methodology for a Prospective Randomized Study of graft patency in Off-pump and On-pump MultI-Vessel coronary artery bypasS Surgery (PROMISS) using multidetector computed tomography

Miguel Sousa Uva^1* , Fernando Matias¹ , Sara Cavaco^2* and Manuel Pedro Magalhães^1*

¹  Departamento da Circulação, Serviço de Cirurgia Cardíaca, Hospital da Cruz Vermelha, Lisboa, 1549-008, Portugal

²  Division of Behavioural Neurology and Cognitive Neuroscience, University of Iowa, Iowa City, USA

author email corresponding author email* Contributed equally

Trials 2008, 9:44doi:10.1186/1745-6215-9-44

Published:	17 July 2008

Abstract

Background

Off-pump coronary artery bypass grafting has been accused of possibly compromising graft patency. Sixteen slice computed tomography has shown good diagnostic accuracy in the assessment of coronary bypass graft patency when compared with conventional coronary artery angiography and is less invasive. The study hypothesis is that coronary artery bypass grafting (CABG) performed without cardiopulmonary bypass (Off-Pump) has equivalent early graft patency as if performed with cardiopulmonary bypass (On-Pump) and may have reduced complication rate.

Methods/Design

The Prospective Randomized Comparison of Off-Pump and On-Pump MultI-vessel Coronary Artery BypasS Surgery (PROMISS) is a controlled, single blinded, single centre clinical trial, comparing early graft patency using 16-slice computed tomography in patients with multi-vessel coronary artery disease operated either without or with extracorporeal circulation. Inclusion criteria are multivessel disease with an indication for first time, isolated, non emergent coronary artery bypass grafting with a minimum of three distal anastomoses. Secondary end points are peri-operative mortality, combined morbidity, length of stay, neuro-cognitive testing at 6 weeks and adverse events, stress test and quality of life at 6 months and one year. The sample size of one hundred and fifty patients was calculated in order to enable the detection of a 5% difference in graft patency, with 80% power, considering a minimum of 3 distal anastomoses per patient. Enrolment started in April 2005 and ended July 2007 with study closure in July 2008.

Conclusion

The PROMISS trial aims to shed new light on the effect of Off-Pump as compared to On-Pump coronary artery bypass surgery on graft patency, assessed by multidetector computed tomography, in unselected patients with multivessel coronary artery disease.

Trial Registration

Current Controlled Trials ISRCTN58800729