Comparing off-pump and on-pump clinical outcomes and costs for diabetic cardiac surgery patients.
BACKGROUND
Observational studies have documented an off-pump over on-pump advantage for high-risk patients, including diabetic patients. Randomized trials have not confirmed this advantage. The VA Randomization On Versus Off Bypass (ROOBY) trial randomly assigned 2,203 coronary artery bypass graft surgery (CABG) patients at 18 sites to either on-pump (n=1,099) or off-pump (n=1,104) procedures. An a priori ROOBY aim was to evaluate treatment impact on diabetic patients.


METHODS
Actively treated diabetic patients (n=835, receiving oral hypoglycemic or insulin medications) received off-pump CABG (n=402) or on-pump CABG (n=433). The primary ROOBY trial endpoints were a short-term composite (30-day operative death or major complications) and a 1-year composite (death, nonfatal acute myocardial infarction, or repeat revascularization). Secondary ROOBY endpoints included 1-year all-cause death, 1-year graft patency, 1-year changes from baseline in neurocognitive status and health-related quality of life, and costs.


RESULTS
Diabetic patients' risk factors at baseline were balanced across treatments. For diabetic patients, the primary short-term composite outcome rate showed a worse trend for off-pump (8.0%) than on-pump (3.9%, p=0.013), with no difference in the 1-year primary composite outcome or 1-year death rate. One-year patency was 83.1% off-pump versus 88.4% on-pump (p=0.004). No differences were found in neurocognitive, health-related quality of life, discharge cost, and 1-year cumulative cost.


CONCLUSIONS
Concordant with the ROOBY trial's overall findings, off-pump CABG yielded no advantage over on-pump CABG for actively treated diabetic patients. The 1-year graft patency was lower and the short-term composite trended higher for off-pump CABG, with no other significant outcome or cost differences.
Northport VA Medical Center, Northport, New York; Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, Colorado.
A Laurie W
AL
Shroyer
Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, Colorado; University of Colorado School of Medicine at the Anschutz Medical Campus, Aurora, Colorado.
Brack
B
Hattler
VA Palo Alto Health Economics Resource Center, Menlo Park, California; Department of Health Research and Policy, Stanford University, Palo Alto, California.
Todd H
TH
Wagner
Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, Colorado.
Janet H
JH
Baltz
Cooperative Studies Program Coordinating Center, Veterans Affairs Medical Center, Perry Point, Maryland. Electronic address: joseph.collins2@va.gov.
Joseph F
JF
Collins
Northport VA Medical Center, Northport, New York.
Brendan M
BM
Carr
Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin; Medical College of Wisconsin, Milwaukee, Wisconsin.
G Hossein
GH
Almassi
VA Boston Healthcare System, West Roxbury, Massachusetts.
Jacquelyn A
JA
Quin
Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, Colorado; Salem Veterans Affairs Medical Center, Salem, Virginia.
Robert B
RB
Hawkins
National Jewish Health, Denver, Colorado.
Elizabeth
E
Kozora
Northport VA Medical Center, Northport, New York.
Muath
M
Bishawi
Greater Los Angeles VA Medical Center, Los Angeles, California.
Ramin
R
Ebrahimi
Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, Colorado; University of Colorado School of Medicine at the Anschutz Medical Campus, Aurora, Colorado.
Frederick L
FL
Grover
D001026:Coronary Artery Bypass / Q000379:methods*; D047549:Coronary Artery Bypass, Off-Pump; D003324:Coronary Artery Disease / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D003326:Coronary Circulation / Q000502:physiology*; D003331:Coronary Vessels / Q000503:physiopathology / Q000601:surgery; D003920:Diabetes Mellitus / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014654:Vascular Patency
D007004:Hypoglycemic Agents