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“Randomised trials of CABG v PCI are no longer possible

“Randomised trials of CABG v PCI are no longer possible & cannot represent real life clinical practice”. Nick Curzen PhD FRCP FESC Southampton University Hospitals. "If a fight lasts more than 7 seconds then you are doing something wrong………… And it's usually that you are being too soft!".

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“Randomised trials of CABG v PCI are no longer possible

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  1. “Randomised trials of CABG v PCI are no longer possible & cannot represent real life clinical practice” Nick Curzen PhD FRCP FESC Southampton University Hospitals

  2. "If a fight lasts more than 7 seconds then you are doing something wrong………… And it's usually that you are being too soft!"

  3. The Current Perception

  4. 2004 data: Ludman Multi-vessel TreatmentAll Clinical Presentations The Current Perception Mean (Range)

  5. Randomised Comparisons of PCI v CABG The Current Perception Stents used

  6. “There’s no difference in death or MI between CABG & PCI” “We just need DES to stop restenosis”

  7. The Current Perception

  8. So- the data from RCTs are relevant to our practice then? NO!: are there really no differences in mortality between CABG & PCI in the real world?

  9. No Differences?

  10. Predictors of Mortality Result of Proportional-Hazard Analyses PCI BetterCABG Better Unadjusted: PCI Covariate adjusted: Renal insufficiency Age in years Previous PCI Insulin-treated diabetes Chronic lung disease Peripheral vasc disease LVEF (10%) Non-insulin diabetes Angiographic score (10%) Left main disease Propensity adjusted: PCI No Differences? 5 4 3 2 1 0 1 2 3 4 5 Circ 2004;109:2290-2295

  11. So- apart from the differences, the data from RCTs are relevant to our practice then? NO!: Are the study populations reallyrepresentative of real life?

  12. REAL LIFE?

  13. 17000-30000 screened!!!! REAL LIFE?

  14. Exclusion Criteria • Previous PCI or CABG • Any total occlusion >1 month old • LVEF<30% • Overt heart failure • H/O CVA • STEMI within 7 days • Diseased saphenous veins REAL LIFE?

  15. Patients Undergoing Angiography 100% 76% do not meet clinical inclusion/exclusion criteria Clinical Criteria 24% 18% cardiologist & surgeon cannot agree amenable to either revascularization methodology Surgeon & Interventional Cardiologist Agreement REAL LIFE? 6% 2% patients will not agree to participate Patient Consent 4% Randomized

  16. So- apart from the differences in mortality in the real world, and the fact that the study populations were not representative of >90% of real life populations, the data from RCTs is relevant to our practicethen? NO!: Did the studies really compare complete revascularisation?

  17. So…….. Maybe the data from these randomised studies aren’t quite so relevant to real life?

  18. ?

  19. All Comers Design All Patients with 3VD/LM Heart Team (surgeon and interventionalist) amenable for both treatments options amenable for only one treatment approach Randomized Arm N=1800 (1:1) Two Registry Arms PCI All captured and followed CABG 2750 captured (750followed) vs TAXUS CABG • reasonable doubt • Goal: to define the most appropriate treatment through randomized trial methods • consensus that only one treatment option (CABG vs PCI) is appropriate • Goal: to define the pool of non randomizable patients and their outcomes

  20. 692 577 are CABG registry! 539 Overall enrollment 831 0.54 292 56

  21. Conclusions “Randomised trials of CABG v PCI are no longer possible becausethey do not represent >90% of real life clinical practice” The extent of CABG registry arm recruitment in SYNTAX so far has already told the common sense cardiologist what he/she needs to know - regardless of the outcome of the randomised group

  22. Acknowledgements Rod Stables Keith Dawkins Boston Scientific Corp M-C Morice Peter Ludman

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