TY - JOUR
T1 - On-Pump Versus Off-Pump Coronary Artery Bypass Surgery in Elderly Patients
T2 - Results From the Danish On-Pump Versus Off-Pump Randomization Study
AU - Houlind, Kim
AU - Kjeldsen, Bo Juul
AU - Madsen, Susanne Nørgaard
AU - Rasmussen, Bodil Steen
AU - Holme, Susanne Juel
AU - Nielsen, Per Hostrup
AU - Mortensen, Poul Erik
AU - for the DOORS Study Group
A2 - Houlind, Kim
A2 - Kjeldsen, Bo Juul
A2 - Madsen, Susanne Nørgaard
A2 - Rasmussen, Bodil Steen
A2 - Holme, Susanne
A2 - Mortensen, Poul Erik
A2 - Hjortdal, Vibeke E.
A2 - Lerbjerg, Gert
A2 - Niebuhr, Uffe
A2 - Aggestrup, Soren
A2 - Nielsen, Per Hostrup
A2 - Sollid, Jorn
A2 - Videbæk, Jorgen
A2 - Sergeant, Paul
A2 - Stahle, Elisabeth
A2 - Wouters, Patrick
A2 - Paulsen, Peter Kildeberg
A2 - Hassager, Christian
A2 - Klausen, Ib Chr.
A2 - Andersen, Grethe
A2 - Meden, Per
A2 - Modrau, Boris
A2 - Sørensen, Henrik Toft
A2 - Johnsen, Søren Påske
A2 - Andersen, Niels Trolle
A2 - Fenger-Grøn, Morten
A2 - Andreasen, Jan Jesper
A2 - Haahr, Poul Erik
A2 - Christensen, John
A2 - Grønlund, Jens
A2 - Nielsen, Per Hostrup
A2 - Jepsen, Mogens Harrits
A2 - Pallesen, Peter Appel
A2 - Ravkilde, Jan
A2 - Aarøe, Jens
A2 - Hansen, Peter Riis
A2 - Hansen, Henrik Steen
A2 - Dalsgaard, Dorthe
A2 - Munkholm, Henrik
A2 - Ehlers, Lars Holger
A2 - Beck, Søren Jepsen
A2 - Kidholm, Kristian
A2 - Lauridsen, Jørgen
PY - 2012
Y1 - 2012
N2 - BACKGROUND: Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially in elderly patients. METHODS AND RESULTS: In a multicenter, randomized trial, we assigned 900 patients >70 years of age to conventional coronary artery bypass grafting or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined end point of death, stroke, or myocardial infarction had occurred. At baseline and 6 months postoperatively, self-assessed quality of life was measured with the Medical Outcomes Study Short Form-36 and EuroQol-5D questionnaires. A 6-month follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined end point within 30 days was 10.2% for conventional coronary artery bypass grafting and 10.7% for OPCAB. Implied risk difference of 0.4% (with a 95% confidence interval, -3.6 to 4.4) showed nonsignificance in a standard test for equality (P=0.83) and for noninferiority with an inferiority margin of 0.5% (P=0.49). At the 6-month follow-up, mortality was 4.7% compared with 4.2% (P=0.75). Both groups showed significant improvement in self-assessed health-related quality of life. CONCLUSIONS: Both conventional coronary artery bypass grafting and OPCAB are safe procedures that improved the quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However, the noninferiority of OPCAB with the prespecified margin could not be confirmed. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00123981.
AB - BACKGROUND: Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially in elderly patients. METHODS AND RESULTS: In a multicenter, randomized trial, we assigned 900 patients >70 years of age to conventional coronary artery bypass grafting or OPCAB surgery. After 30 days, a blinded end-point committee assessed whether a combined end point of death, stroke, or myocardial infarction had occurred. At baseline and 6 months postoperatively, self-assessed quality of life was measured with the Medical Outcomes Study Short Form-36 and EuroQol-5D questionnaires. A 6-month follow-up of mortality was performed through the Danish National Registry. The proportion of patients experiencing the combined end point within 30 days was 10.2% for conventional coronary artery bypass grafting and 10.7% for OPCAB. Implied risk difference of 0.4% (with a 95% confidence interval, -3.6 to 4.4) showed nonsignificance in a standard test for equality (P=0.83) and for noninferiority with an inferiority margin of 0.5% (P=0.49). At the 6-month follow-up, mortality was 4.7% compared with 4.2% (P=0.75). Both groups showed significant improvement in self-assessed health-related quality of life. CONCLUSIONS: Both conventional coronary artery bypass grafting and OPCAB are safe procedures that improved the quality of life when performed in elderly patients. No major differences in intermediate-term outcomes were found. However, the noninferiority of OPCAB with the prespecified margin could not be confirmed. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00123981.
UR - http://www.ncbi.nlm.nih.gov/pubmed/22523305
U2 - 10.1161/CIRCULATIONAHA.111.052571
DO - 10.1161/CIRCULATIONAHA.111.052571
M3 - Journal article
SN - 0009-7322
VL - 125
SP - 2431
EP - 2439
JO - Circulation
JF - Circulation
IS - 20
ER -