Clinical trial NCT00719667: German Off Pump Coronary Artery Bypass in Elderly Study
Official title: German Off Pump Coronary Artery Bypass in Elderly Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Disease
Keywords: OPCAB
coronary
bypass
grafting
off pump
Lead sponsor: German Off Pump Coronary Artery Bypass in Elderly Study Group
Sponsor class: NETWORK
Collaborators: name: Institut für Klinisch-Kardiovaskuläre Forschung GmbH
name: Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie
First posted: 2008-07-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old.

Hypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).


Eligibility criteria: Inclusion Criteria:

* older or 75 years
* indication for elective bypass operation
* patient has signed written consent before randomization

Exclusion Criteria:

* previous heart surgery
* patient unable to give informed consent

Primary outcomes:
measure: All cause mortality
timeFrame: 1 month and 12 month
measure: Myocardial infarction
timeFrame: 1 month and 12 month
measure: Stroke
timeFrame: 1 month and 12 month
measure: Any revascularisation
timeFrame: 1 month and30 month
measure: renal failure
timeFrame: 1 month and 12 month
Secondary outcomes:
measure: ventilation time
timeFrame: post op
measure: blood transfusion
timeFrame: post op
measure: length of stay in intensive-care unit
timeFrame: post op
Other outcomes:
Locations:
city: Neustadt/Saale
country: Germany
facility: Herzchirurgie Neustadt/Saale
state: Bayern
city: Regensburg
country: Germany
facility: Universität Regensburg
state: Bayern
Study officials:
affiliation: Herzchirurgie Bad Neustadt/Saale
name: Anno Diegeler, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universität Regensburg
name: Michael Hilker, PD
role: STUDY_CHAIR
References:
citation: Diegeler A, Borgermann J, Kappert U, Hilker M, Doenst T, Boning A, Albert M, Farber G, Holzhey D, Conradi L, Riess FC, Veeckmann P, Minorics C, Zacher M, Reents W. Five-Year Outcome After Off-Pump or On-Pump Coronary Artery Bypass Grafting in Elderly Patients. Circulation. 2019 Apr 16;139(16):1865-1871. doi: 10.1161/CIRCULATIONAHA.118.035857.
citation: Faerber G, Zacher M, Reents W, Boergermann J, Kappert U, Boening A, Diegeler A, Doenst T; GOPCABE investigators. Female sex is not a risk factor for post procedural mortality in coronary bypass surgery in the elderly: A secondary analysis of the GOPCABE trial. PLoS One. 2017 Aug 30;12(8):e0184038. doi: 10.1371/journal.pone.0184038. eCollection 2017.
citation: Diegeler A, Borgermann J, Kappert U, Breuer M, Boning A, Ursulescu A, Rastan A, Holzhey D, Treede H, Riess FC, Veeckmann P, Asfoor A, Reents W, Zacher M, Hilker M; GOPCABE Study Group. Off-pump versus on-pump coronary-artery bypass grafting in elderly patients. N Engl J Med. 2013 Mar 28;368(13):1189-98. doi: 10.1056/NEJMoa1211666. Epub 2013 Mar 11.