1. The German Off-Pump Coronary Artery Bypass Grafting in
Elderly Patients (GOPCABE) Study
Prof. Dr. med. Anno Diegeler
Bad Neustadt Heart Center
For the GOPCABE study group

2. Payment exclusively for web-based data
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Disclosures
Sponsor of the study is the German Society of
Thoracic and Cardiovascular Surgery (DGTHG)
Unrestricted grant (≅ Euro) from
Maquet™ Inc. Rastatt Germany
Payment exclusively for web-based data
management of the IKKF™ (Institut für klinisch-
kardiovaskuläre Forschung), Munich

3. Several randomized trials* with different patient
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Background
There are some rationales, that avoiding the
heart-lung machine in coronary bypass surgery
reduces invasiveness and by this has a clinical
benefit on major adverse events (MACCE)
However…
Several randomized trials* with different patient
characteristics could not confirm a significant
difference
* ROOBY1; CORONARY2; BEST SURGICAL REVASCULARIZATION3 1 3
N Engl J Med 2009; 361: 1827 – 37
Circulation 2010; 121: 2
N Engl J Med 2012; 366: 1489 – 97

4. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

5. • 12 German Centers with high experience level
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
The GOPCABE –Trial
Features
• Patients ≥ 75 years
• All comers screened
• 12 German Centers with high experience level
for both techniques
• Nominated Surgeons for both techniques
• Screening log for excluded patients
Enrollement between 6/2008 and 9/2011

6. • Additional cardiac disease necessitating • Previous pericardiotomy
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Patient exclusion criteria
• Additional cardiac disease necessitating
additional surgery
• Previous pericardiotomy
• Immediate surgery i.e. within 24 hours after
admission
• Inability or unwillingness to provide consent
Anatomy , morphology of the coronary artery or left
ventricular function was not an exclusion criteria

7. Primary endpoint: at 30 days after surgery
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Outcome Features
Hypothesis: Off pump is not able to reduce a combined
endpoint MACCRE to 30%; OR 0.63 with a power of 90%
MACCRE: death, myocardial infartion, additional revascularization, stroke, new
onset renal replacement therapy
Primary endpoint: at 30 days after surgery
Secondary endpoints: 12 months MACCRE;
Ventilation time, stay on ICU, hospital stay,
resources utilization

8. German Off-Pump CABG in Elderly Trial (GOPCABE)
patients > 75 years with isolated
first-time CABG
n = 4355
potentially eligible patients
n = 3683
Randomization
n = 2539 (69%)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
exclusion criteria:
- urgent operation (n = 526)
- inability to provide consent (n = 122)
- participation in another study (n = 24)
- unwillingness to provide consent
(n = 537)
- logistic reasons (n= 607)
off-pump CABG (n = 1271)
isolated CABG performed by
assigned surgeon (n = 1191)
available for analysis
at 30 days (n = 1187)
at 12 months (n = 1179)
On-pump CABG (n = 1268)
isolated CABG performed by
assigned surgeon (n = 1212)
available for analysis
at 30 days (n = 1207)
at 12 months (n = 1191)
exclusion after randomization
(n = 80)
- additional cardiovascular
procedure (n = 20)
- urgent operation (n = 9)
- no surgery performed (n = 16)
- withdrawn consent (n = 19)
- miscellaneous (n = 16)
- lost to follow-up (n = 3)
- withdrawn consent (n = 1)
- lost to follow-up (n = 8)
exclusion after randomization
(n = 56)
- additional cardiovascular
procedure (n = 21)
- urgent operation (n = 6)
- no surgery performed (n = 11)
- withdrawn consent (n = 11)
- missing consent form (n = 1)
- death before surgery (n = 1)
- miscellaneous (n = 5)
- lost to follow-up (n = 4)
- withdrawn consent (n = 1)
- lost to follow-up (n = 15)

9. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
baseline characteristics [No (%)]
on-pump
off-pump
baseline characteristics [No (%)]
on-pump
off-pump
n = 1207
n = 1187
left ventricular
fraction
ejection
< 30%
39 (3.2)
25 (2.1)
30-50%
341 (28.3)
365 (30.7)
female gender
389 (32.2)
366 (30.8)
> 50%
827 (68.5)
797 (67.1)
age [years]
body mass index [kg / m2]
78.4 ± 2.87
27.8 ± 4.1
78.6 ± 2.98
27.8 ± 4.1
CCS
scale
angina
grading I II
230 (19.0)
425 (35.2)
224 (18.9)
396 (33.4)
insulin-dependent diabetes mellitus
chronic obstructive pulmonary
disease
previous stroke
peripheral vascular disease
pulmonary arterial hypertension
previous myocardial infarction
previous percutaneous coronary
intervention
history of atrial fibrillation
implanted pacemaker
166 (13.8)
118 (9.8)
95 (7.9)
392 (32.5)
26 (2.2)
456 (37.8)
263 (21.8)
190 (15.7)
33 (2.7)
179 (15.1)
127 (10.7)
121 (10.2)
388 (32.7)
39 (3.3)
427 (36.0)
268 (22.6)
177 (14.9)
31 (2.6)
III IV
extent of coronary artery disease
1 vessel
2 vessel
3 vessel
left main disease + 1 – 3 vessel
renal replacement therapy
critical condition
496 (41.1)
56 (4.6)
14 (1.2)
106 (8.8)
730 (60.5)
357 (29.6)
11 (0.9)
36 (3.0)
523 (44.1)
44 (3.7)
23 (1.9)
119 (10.0)
712 (60.0)
333 (28.1)
11 (0.9)
22 (1.9)
creatinine level
< 2.3 mg/dl
1169 (96.9)
1150 (96.9)
logistic EuroSCORE
8.23 ± 6.61
8.31 ± 7.17
> 2.3 mg/dl
27 (2.2)
26 (2.2)

10. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
off-Pump
(n = 1187)
on-Pump
(n = 1207)
No. (%)
mean number of anticipated grafts *
anticipated number of grafts 1 2 3 4
>4
mean number of performed grafts ***
number of performed grafts ***
anticipated vs. performed grafts per patient ***
no. anticipated = No. performed
no. anticipated < No. performed
no. anticipated > No. performed
2.95
28 (2.4%)
242 (20.4%)
700 (59%)
197 (16.6%)
20 (1.7%)
2.66
74 (6.2 %)
414 (34.9 %)
557 (46.9 %)
123 (10.4 %)
19 (1.6 %)
663 (56%)
121 (10 %)
403 (34 %) 3
12 (1%)
260 (21.5%)
683 (56.6%)
222 (18.4%)
30 (2.5%)
2.84
44 (3.6 %)
382 (31.6 %)
551 (45.7 %)
187 (15.5 %)
43 (3.5 %)
651 (54 %)
202 (17 %)
354 (29 %)

11. Cross-over by conversion
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Cross-over by
conversion
off-pump
n = 116 (9.7%)
on-pump
n = 62 (5.1%)
before skin incision
61(5.1%)
- hemodynamic instability
/ unstabe angina (n = 6)
- logistic reasons (n = 52)
- unknown (n = 3)
- calcified ascending aorta (n = 13)
- logistic reaosons (n = 21)
- unknown (n = 2)
36(2.9%)
before first anastomosis
- hemodynamic instability 34(2.8%)
/ myocardial ischemia (n = 17)
- diffuse calcified small vessel (n = 6)
- intramyocardial vessel (n = 3)
- pericardial adhesion / inadequate
vessel exposure (n = 3)
- bleeding / myocardial injury (n = 2)
- unknown (n = 3)
- calcified ascending aorta (n = 24)
- miscellaneous (n = 2)
61(2.1%)
after first anastomosis
21(1.8%)
- hemodynamic instability
/ myocardial ischemia (n = 16)
- diffuse calcified small vessel (n = 1)
- intramyocardial vessel (n = 1)
- pericardial adhesion / inadequate
vessel exposure (n = 1)
- revision of coronary anastomosis (n = 2)

12. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
German Off-Pump CABG in Elderly Trial (GOPCABE)
Primary endpoint 30 days after surgery
modified intention to treat analysis
primaryendpoint[no(%)]
off-pump
on-pump
oddsratio
[95%CI]
pvalue
30daysaftersurgery
n=1187
n=1207
composite
93(7.8%)
99(8.2%)
0.95[0.71–1.28]
0.74
deathwithin30daysaftersurgery
31(2.6%)
34(2.8%)
0.92[0.57–1.51]
0.75
myocardialinfarction
18(1.5%)
20(1.7%)
0.92[0.51–1.66]
0.79
stroke
26(2.2%)
32(2.7%)
0.83[0.50–1.38]
0.47
repeatrevascularization
15(1.3%)
5(0.4%)
2.42[1.03–5.72]
0.04
newrenalreplacementtherapy
29(2.4%)
37(3.1%)
0.80[0.49–1.29]
0.36

13. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
German Off-Pump CABG in Elderly Trial (GOPCABE)
Composite endpoint (death, myocardial infarction, stroke, repeat revascularisation,
new renal replacement therapy) within 30 days after surgery according to center

14. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
German Off-Pump CABG in Elderly Trial (GOPCABE)
Primary endpoint 30 days after surgery
Per protocol analysis
primaryendpoint[no(%)]
off-pump
on-pump
oddsratio
pvalue
30daysaftersurgery
n=1071
n=1145
[95%CI]
composite
75(7.0%)
92(8.0%)
0.87[0.63–1.20]
0.40
deathwithin30daysafter
surgery
22(2.1%)
31(2.7%)
0.76[0.44–1.31]
0.32
myocardialinfarction
13(1.2%)
19(1.7%)
0.77[0.40–1.47]
0.42
stroke
20(1.9%)
32(2.8%)
0.68[0.39–1.18]
0.17
repeatrevascularization
14(1.3%)
4(0.3%)
2.65[1.10–6.40]
0.03
newrenalreplacementtherapy
24(2.2%)
33(2.9%)
0.80[0.48–1.34]

15. German Off-Pump CABG in Elderly Trial (GOPCABE)
Secondary endpoints
use of resources:
Off-pump
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
On-pump
patients with allogenic blood transfusion ***
units of transfused packed red blood cells† ***
operative time [min]†
duration of mechanical ventilation [hours]†
postoperative length of stay ICU [days]†
postoperative length of stay hospital [days]†
668 (56.3%)
2 (1)
175 (170)
25.1 (12)
3.7 (2)
11.5 (9)
757 (62.7%)
2.4 (2)
174 (168)
30.7 (12)
4.3 (2)
11.6 (9)

16. German Off-Pump CABG in Elderly Trial (GOPCABE)
12 months follow-up
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
primaryendpoint[no(%)]
off-pump
on-pump
hazardratio
[95%CI]
pvalue
12monthsaftersurgery
n=1179
n=1191
composite
154(13.1)
167(14.0)
0.93[0.76–1.16]
0,483
deathwithinoneyearaftersurgery
83(7.0)
95(8.0)
0.88[ ]
0.383
myocardialinfarction
25(2.1)
28(2.4)
0.90[0.53–1.54]
0.701
stroke
41(3.5)
52(4.4)
0.79[0.53–1.19]
0.260
repeatrevascularization
36(3.1)
24(2.0)
1.52[0.90–2.54]
0.112
newrenalreplacementtherapy
34(2.9)
42(3.5)
0.82[0.52–1.28]
0.375

17. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

18. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

19. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

20. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

21. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

22. German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale

23. • Modified intention to treat analysis
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Limitation
• Modified intention to treat analysis
• Nomitation of a surgeon creates a time interval
before surgery and more cross overs
• Only local data confirmation performed
• Minor events such as neurocognitive
impairments or graft patency not evaluated

24. In a randomized trial comparing off- pump and on-
German Off-Pump CABG in Elderly Trial (GOPCABE)
Prof. Dr. Anno Diegeler
Herz- und Gefäß-Klinik
Bad Neustadt a. d. Saale
Conclusion
In a randomized trial comparing off- pump and on-
pump coronary bypass surgery we did not find a
significant difference in clinical outcome at 30 days
and at 12 months