Revascularización miocárdica sin bomba; iguales resultados al año que la cirugía con bomba

• 1. CORONARY: The Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization StudyResults at 1 Year Andr LamyPopulation Health Research Institute Hamilton Health Sciences McMaster UniversityHamilton, CANADAon behalf of the CORONARY InvestigatorsDisclosures: CORONARY was funded by a grant from the Canadian Institutesof Health Research (CIHR).

2. Background Benefits and risks of performing CABG surgery onbeating heart (off pump) not clearly established. Meta-analyses of 59 trials involving 8961 pts No differences in major CV outcomes except strokes ROOBY (1 Year) Primary Outcome: Off-pump is worse (p=0.04) CV Deaths: Off-pump is worse (p=0.03) 2 3. CORONARY Trial Organization 79 centers in 19 countries 4,752 patients recruited between (November 2006October 2011) Designed, coordinated, managed and data analysedand reported by the Population Health ResearchInstitute, Hamilton Health Sciences and McMasterUniversity in Hamilton, Canada The data was monitored by independent DSMB Funded by Canadian Institutes of Health Research 3 4. Inclusion/Exclusion Criteria Inclusion Criteria Isolated CABG with median sternotomy One of the following: 1. Peripheral vascular disease 2. Cerebrovascular disease 3. Renal Insufficiency 4. Age 70 years 5. Age 60 -69 with at least one risk factor (diabetes, urgentrevascularization, smoker, LVEF 35%) 6. Age 55 -59 with at least two of the above risk factors Exclusions Additional cardiac procedure planned Contraindications to off-pump or on-pump CABG Emergency or re-do CABG 5 5. Qualifications of Surgeons Surgical expertise-based randomization > 2 years of experience as staff cardiac surgeon and > 100 cases of one or both techniques Trainees were not allowed to be primaryoperators 6 6. Primary Outcomes 1st Co-Primary OutcomeComposite of total mortality, stroke, non fatal myocardialinfarction, new renal failure at 30 days post randomization results presented ACC 2012 results at 1 year 2nd Co-Primary OutcomeComposite of above outcomes plus repeat coronaryrevascularization over 5 yrs of follow-up (expected 2016)7 7. Baseline Characteristics OFF-PUMP ON-PUMP (n = 2375) (n = 2377)Mean Age (years)67.667.5Males (%) 80.081.7Prior MI33.835.2Previous Stroke 6.77.8Peripheral Arterial Disease 8.08.2Congestive Heart Failure5.96.6Urgent Surgery39.538.1Euroscore 0228.627.8 3551.754.2 > 518.116.8 10 8. Baseline Disease Pre-op Angiogram OFF-PUMP ON-PUMP (n = 2375) (n = 2377)%%Left Main 22.120.9Triple Vessel 56.160.4Double Vessel 18.716.4Single Vessel 3.02.1 11 9. 1st Co-Primary Outcome (1 Year) Off Pump On Pump Hazard p % % Ratio95% CI valuePrimary Outcome12.1 13.30.910.77-1.07 0.24Death, Stroke, MI, Renal FailureComponents Death 5.15.01.030.80-1.32 Stroke1.51.70.900.57-1.41 Non Fatal MI6.87.50.900.73-1.12 New Renal Failure 1.31.30.970.59-1.60 14 10. Death/MI/Stroke/New Renal Failure0.200.15at 1 Year On Pump CABGCumulative Event Rate Off Pump CABG0.10 HR 0.910.05 95% CI 0.77-1.07 p value 0.240.0 0 3 6 912 15 11. Other Outcomes at 1 year Off Pump On Pump Hazard95% CI p value % % RatioCardiovascular Mortality 4.24.01.030.78-1.370.83Angina 1.00.91.050.58-1.880.87PCI1.10.81.430.79-2.570.23Re-do CABG 0.3 0.047.000.86-57.00.07PCI/Re-do CABG 1.40.81.660.95-2.890.07Primary Outcome per Protocol 11.513.20.860.73-1.020.08 16 12. Primary Outcome between 31 days and 1 YearOff Pump On Pump Hazard p% % Ratio95% CI valuePrimary Outcome2.63.20.790.55-1.13 0.19Death/MI/Stroke/Renal FailureComponentsDeath 2.12.30.870.58-1.31Stroke0.50.60.830.36-1.92Non Fatal MI0.20.40.500.15-1.65New Renal Failure 0.10.20.500.092.7117 13. Other Outcomes between 31 days and 1 Year Off Pump On Pump Hazard95% CI p value % % RatioCardiovascular Mortality 1.51.51.060.65-1.730.82Angina 0.80.71.130.56-2.260.74PCI0.70.61.150.55-2.410.72Re-do CABG