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) 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 ( ≅ 250.000 Euro) from Maquet™ Inc. Rastatt Germany Payment exclusively for web-based data management of the IKKF™ (Institut für klinisch - kardiovaskuläre Forschung), Munich
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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 * ROOBY 1 ; CORONARY 2 ; BEST SURGICAL REVASCULARIZATION 3 1 N Engl J Med 2009; 361: 1827 – 37 2 N Engl J Med 2012; 366: 1489 – 97 3 Circulation 2010; 121: 498 - 504
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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) potentially eligible patients n = 3683 - unwillingness to provide consent (n = 537) - logistic reasons (n= 607) Randomization n = 2539 (69%) off-pump CABG (n = 1271) On-pump CABG (n = 1268) exclusion after randomization exclusion after randomization (n = 56 ) (n = 80) - additional cardiovascular - additional cardiovascular procedure (n = 21) procedure (n = 20) - urgent operation (n = 6) - urgent operation (n = 9) - no surgery performed (n = 11) - no surgery performed (n = 16) - withdrawn consent (n = 11) - withdrawn consent (n = 19) isolated CABG performed by isolated CABG performed by - missing consent form (n = 1) - miscellaneous (n = 16) assigned surgeon (n = 1191 ) assigned surgeon (n = 1212) - death before surgery (n = 1) - miscellaneous (n = 5) - lost to follow-up (n = 3) - lost to follow-up (n = 4) - withdrawn consent (n = 1) - withdrawn consent (n = 1) available for analysis available for analysis at 30 days (n = 1207) at 30 days (n = 1187) - lost to follow-up (n = 15) - lost to follow-up (n = 8) - withdrawn consent (n = 1) available for analysis available for analysis at 12 months (n = 1179 ) at 12 months (n = 1191 )
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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 l eft ventricular ejection < 30% 39 (3.2) 25 (2.1) fraction 30-50% 341 (28.3) 365 (30.7) female gender 389 (32.2) 366 (30.8) > 50% 827 (68.5) 797 (67.1) 78.4 ± 2.87 78.6 ± 2.98 age [years] I CCS angina grading 230 (19.0) 224 (18.9) scale body mass index [kg / m 2 ] 27.8 ± 4.1 27.8 ± 4.1 II 425 (35.2) 396 (33.4) insulin-dependent diabetes mellitus 166 (13.8 ) 179 (15.1) III 496 (41.1) 523 (44.1) IV 56 (4.6) 44 (3.7) chronic obstructive pulmonary 118 (9.8) 127 (10.7) disease extent of coronary artery disease previous stroke 95 (7.9) 121 (10.2) 1 vessel 14 (1.2) 23 (1.9) peripheral vascular disease 392 (32.5) 388 (32.7) pulmonary arterial hypertension 26 (2.2) 39 (3.3) 2 vessel 106 (8.8) 119 (10.0) previous myocardial infarction 456 (37.8) 427 (36.0) 3 vessel 730 (60.5) 712 (60.0) previous percutaneous coronary 263 (21.8) 268 (22.6) left main disease + 1 – 3 vessel intervention 357 (29.6) 333 (28.1) history of atrial fibrillation 190 (15.7) 177 (14.9) renal replacement therapy 11 (0.9) 11 (0.9) implanted pacemaker 33 (2.7) 31 (2.6) critical condition 36 (3.0) 22 (1.9) creatinine level < 2.3 mg/dl 1169 (96.9) 1150 (96.9) 8.23 ± 6.61 8.31 ± 7.17 logistic EuroSCORE > 2.3 mg/dl 27 (2.2) 26 (2.2)
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale off-Pump on-Pump (n = 1187) (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 %)
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale Cross-over by on-pump off-pump n = 62 (5.1%) n = 116 (9.7%) conversion before skin incision 61(5.1%) - hemodynamic instability - calcified ascending aorta (n = 13) / unstabe angina (n = 6) - logistic reaosons (n = 21) - logistic reasons (n = 52) - unknown (n = 2) 36(2.9%) - unknown (n = 3) before first anastomosis 34(2.8%) - hemodynamic instability - calcified ascending aorta (n = 24) / myocardial ischemia (n = 17) - miscellaneous (n = 2) - diffuse calcified small vessel (n = 6) 61(2.1%) - intramyocardial vessel (n = 3) - pericardial adhesion / inadequate vessel exposure (n = 3) - bleeding / myocardial injury (n = 2) - unknown (n = 3) 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)
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale Primary endpoint 30 days after surgery modified intention to treat analysis primary endpoint [no (%)] off-pump on-pump p value odds ratio [95% CI] 30 days after surgery n = 1187 n = 1207 0.95 [0.71 – 1.28] composite 93 (7.8%) 99 (8.2%) 0.74 0.92 [0.57 – 1.51] death within 30 days after surgery 31 (2.6%) 34 (2.8%) 0.75 0.92 [0.51 – 1.66] myocardial infarction 18 (1.5%) 20 (1.7%) 0.79 0.83 [0.50 – 1.38] stroke 26 (2.2%) 32 (2.7%) 0.47 2.42 [1.03 – 5.72] repeat revascularization 15 (1.3%) 5 (0.4%) 0.04 0.80 [0.49 – 1.29] new renal replacement therapy 29 (2.4%) 37 (3.1%) 0.36
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) 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
Prof. Dr. Anno Diegeler German Off-Pump CABG in Elderly Trial (GOPCABE) Herz- und Gefäß-Klinik Bad Neustadt a. d. Saale Primary endpoint 30 days after surgery Per protocol analysis primary endpoint [no (%)] off-pump on-pump odds ratio p value 30 days after surgery n = 1071 n = 1145 [95% CI] 0.87 [0.63 – 1.20] composite 75 (7.0%) 92 (8.0%) 0.40 death within 30 days after 0.76 [0.44 – 1.31] 22 (2.1%) 31 (2.7%) 0.32 surgery 0.77 [0.40 – 1.47] myocardial infarction 13 (1.2%) 19 (1.7%) 0.42 0.68 [0.39 – 1.18] stroke 20 (1.9%) 32 (2.8%) 0.17 2.65 [1.10 – 6.40] repeat revascularization 14 (1.3%) 4 (0.3%) 0.03 0.80 [0.48 – 1.34] new renal replacement therapy 24 (2.2%) 33 (2.9%) 0.40
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