The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS).
BACKGROUND
Coronary Artery Bypass Graft operation for ischemic heart disease provides improved quality of life and, in some patients, prolonged survival. Concern has, however, been raised about complications that may be related to the use of cardiopulmonary by-pass (CPB) and aortic cross-clamping. It has been hypothesized that when coronary artery by-pass grafting is performed without the use of CPB, the rate of serious complications is reduced.


METHODS
The trial is designed as an open, randomized, controlled, clinical trial with blinded assessment of end-points. Patients at or above 70 years of age, referred for surgical myocardial revascularisation, are included and randomised to receive coronary artery by-pass grafting either with or without the use of CPB and aortic cross-clamping. Follow-up is performed by clinical, biochemical, electrocardiographic, and angiographic data that are evaluated by independent committees that are blinded with respect to the result of the randomisation. End points include mortality, stroke, myocardial infarction, graft patency, quality of life, and cost-effectiveness. The trial is performed in four different Danish, cardiac surgery centres.


BACKGROUND
ClinicalTrials.gov NCT00123981.
Houlind
Kim
K
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark. kim.houlind@iekf.au.dk
Kjeldsen
Bo Juul
BJ
Madsen
Susanne Nørgaard
SN
Rasmussen
Bodil Steen
BS
Holme
Susanne Juel
SJ
Schmidt
Thomas Andersen
TA
Haahr
Poul Erik
PE
Mortensen
Poul Erik
PE
D000368:Aged; D002315:Cardiopulmonary Bypass / Q000401:mortality; D047549:Coronary Artery Bypass, Off-Pump / Q000401:mortality; D003718:Denmark; D005500:Follow-Up Studies; D006801:Humans; D009203:Myocardial Infarction / Q000401:mortality; D017202:Myocardial Ischemia / Q000401:mortality / Q000601:surgery*; D011183:Postoperative Complications / Q000401:mortality / Q000517:prevention & control*; D012107:Research Design; D020521:Stroke / Q000401:mortality