Elderly Patients (GOPCABE) Study Prof. Dr. med. Anno Diegeler Bad - - PowerPoint PPT Presentation

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Elderly Patients (GOPCABE) Study Prof. Dr. med. Anno Diegeler Bad - - PowerPoint PPT Presentation

Oct 20, 2023 281 likes •540 views

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 Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE)

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For the GOPCABE study group

The German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients (GOPCABE) Study

  • Prof. Dr. med. Anno Diegeler

Bad Neustadt Heart Center

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

Sponsor of the study is the German Society of Thoracic and Cardiovascular Surgery (DGTHG) Unrestricted grant (≅250.000 Euro) from Maquet™ Inc. Rastatt Germany Payment exclusively for web-based data management of the IKKF™ (Institut für klinisch- kardiovaskuläre Forschung), Munich Disclosures

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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… Background Several randomized trials* with different patient characteristics could not confirm a significant difference

* ROOBY1; CORONARY2; BEST SURGICAL REVASCULARIZATION3

1 N Engl J Med 2009; 361: 1827 – 37 2 N Engl J Med 2012; 366: 1489 – 97 3 Circulation 2010; 121: 498 - 504

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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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

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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

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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

  • nset renal replacement therapy

Primary endpoint: at 30 days after surgery Secondary endpoints: 12 months MACCRE; Ventilation time, stay on ICU, hospital stay, resources utilization

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

patients > 75 years with isolated first-time CABG n = 4355

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)

Randomization n = 2539 (69%) 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)

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)

available for analysis at 30 days (n = 1187)

  • lost to follow-up (n = 3)
  • withdrawn consent (n = 1)

available for analysis at 30 days (n = 1207)

  • lost to follow-up (n = 4)
  • withdrawn consent (n = 1)
  • lost to follow-up (n = 8)

available for analysis at 12 months (n = 1179) potentially eligible patients n = 3683 On-pump CABG (n = 1268)

  • ff-pump CABG (n = 1271)

isolated CABG performed by assigned surgeon (n = 1191) isolated CABG performed by assigned surgeon (n = 1212)

  • lost to follow-up (n = 15)
  • withdrawn consent (n = 1)

available for analysis at 12 months (n = 1191)

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

baseline characteristics [No (%)]

  • n-pump
  • ff-pump

n = 1207 n = 1187 female gender

389 (32.2) 366 (30.8)

age [years]

78.4 ± 2.87 78.6 ± 2.98

body mass index [kg / m2] 27.8 ± 4.1

27.8 ± 4.1

insulin-dependent diabetes mellitus

166 (13.8)

179 (15.1) chronic obstructive pulmonary disease

118 (9.8) 127 (10.7)

previous stroke

95 (7.9) 121 (10.2)

peripheral vascular disease

392 (32.5) 388 (32.7)

pulmonary arterial hypertension

26 (2.2) 39 (3.3)

previous myocardial infarction

456 (37.8) 427 (36.0)

previous percutaneous coronary intervention

263 (21.8) 268 (22.6)

history of atrial fibrillation

190 (15.7) 177 (14.9)

implanted pacemaker

33 (2.7) 31 (2.6)

creatinine level < 2.3 mg/dl

1169 (96.9) 1150 (96.9)

> 2.3 mg/dl

27 (2.2) 26 (2.2)

baseline characteristics [No (%)]

  • n-pump
  • ff-pump

left

ventricular ejection fraction < 30% 39 (3.2) 25 (2.1) 30-50% 341 (28.3) 365 (30.7) > 50% 827 (68.5) 797 (67.1)

CCS angina grading scale

I 230 (19.0) 224 (18.9) II 425 (35.2) 396 (33.4) III 496 (41.1) 523 (44.1) IV 56 (4.6) 44 (3.7)

extent of coronary artery disease

1 vessel 14 (1.2) 23 (1.9) 2 vessel 106 (8.8) 119 (10.0) 3 vessel 730 (60.5) 712 (60.0) left main disease + 1 – 3 vessel 357 (29.6) 333 (28.1) renal replacement therapy 11 (0.9) 11 (0.9) critical condition 36 (3.0) 22 (1.9)

logistic EuroSCORE

8.23 ± 6.61 8.31 ± 7.17

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SLIDE 10

German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

  • ff-Pump

(n = 1187)

  • n-Pump

(n = 1207)

  • No. (%)

mean number of anticipated grafts * 2.95 3 anticipated number of grafts 1 28 (2.4%) 12 (1%) 2 242 (20.4%) 260 (21.5%) 3 700 (59%) 683 (56.6%) 4 197 (16.6%) 222 (18.4%) >4 20 (1.7%) 30 (2.5%) mean number of performed grafts *** 2.66 2.84 number of performed grafts *** 1 74 (6.2 %) 44 (3.6 %) 2 414 (34.9 %) 382 (31.6 %) 3 557 (46.9 %) 551 (45.7 %) 4 123 (10.4 %) 187 (15.5 %) > 4 19 (1.6 %) 43 (3.5 %) anticipated vs. performed grafts per patient ***

  • no. anticipated = No. performed

663 (56%) 651 (54 %)

  • no. anticipated < No. performed

121 (10 %) 202 (17 %)

  • no. anticipated > No. performed

403 (34 %) 354 (29 %)

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

  • n-pump

n = 62 (5.1%)

  • ff-pump

n = 116 (9.7%) before first anastomosis before skin incision after first anastomosis

Cross-over by conversion

  • 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)

21(1.8%)

  • calcified ascending aorta (n = 13)
  • logistic reaosons (n = 21)
  • unknown (n = 2)
  • hemodynamic instability

/ unstabe angina (n = 6)

  • logistic reasons (n = 52)
  • unknown (n = 3)

61(5.1%) 36(2.9%)

  • hemodynamic instability

/ 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)

34(2.8%) 61(2.1%)

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

primary endpoint [no (%)]

  • ff-pump
  • n-pump
  • dds ratio

[95% CI] p value 30 days after surgery n = 1187 n = 1207 composite 93 (7.8%) 99 (8.2%) 0.95 [0.71 – 1.28] 0.74 death within 30 days after surgery 31 (2.6%) 34 (2.8%) 0.92 [0.57 – 1.51] 0.75 myocardial infarction 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 repeat revascularization 15 (1.3%) 5 (0.4%) 2.42 [1.03 – 5.72] 0.04 new renal replacement therapy 29 (2.4%) 37 (3.1%) 0.80 [0.49 – 1.29] 0.36

modified intention to treat analysis

Primary endpoint 30 days after surgery

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

Composite endpoint (death, myocardial infarction, stroke, repeat revascularisation, new renal replacement therapy) within 30 days after surgery according to center

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

primary endpoint [no (%)]

  • ff-pump
  • n-pump
  • dds ratio

p value 30 days after surgery n = 1071 n = 1145 [95% CI] composite 75 (7.0%) 92 (8.0%) 0.87 [0.63 – 1.20] 0.40 death within 30 days after surgery 22 (2.1%) 31 (2.7%) 0.76 [0.44 – 1.31] 0.32 myocardial infarction 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 repeat revascularization 14 (1.3%) 4 (0.3%) 2.65 [1.10 – 6.40] 0.03 new renal replacement therapy 24 (2.2%) 33 (2.9%) 0.80 [0.48 – 1.34] 0.40

Primary endpoint 30 days after surgery

Per protocol analysis

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

use of resources: patients with allogenic blood transfusion *** 668 (56.3%) 757 (62.7%) units of transfused packed red blood cells† *** 2 (1) 2.4 (2)

  • perative time [min]†

175 (170) 174 (168) duration of mechanical ventilation [hours]† 25.1 (12) 30.7 (12) postoperative length of stay ICU [days]† 3.7 (2) 4.3 (2) postoperative length of stay hospital [days]† 11.5 (9) 11.6 (9)

Secondary endpoints

Off-pump On-pump

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

primary endpoint [no (%)]

  • ff-pump
  • n-pump

hazard ratio [95% CI] p value 12 months after surgery n = 1179 n = 1191 composite 154 (13.1) 167 (14.0) 0.93 [0.76 – 1.16] 0,483 death within one year after surgery 83 (7.0) 95 (8.0) 0.88 [0.65 . 1.18] 0.383 myocardial infarction 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 repeat revascularization 36 (3.1) 24 (2.0) 1.52 [0.90 – 2.54] 0.112 new renal replacement therapy 34 (2.9) 42 (3.5) 0.82 [0.52 – 1.28] 0.375

12 months follow-up

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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SLIDE 18

German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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SLIDE 19

German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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SLIDE 20

German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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SLIDE 21

German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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German Off-Pump CABG in Elderly Trial (GOPCABE)

  • Prof. Dr. Anno Diegeler

Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale

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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

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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