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UK Trial Update

UK Trial Update. Simon Redwood Advanced Angioplasty Jan 2006. No Conflict of Interest. BCIS-1 Study B alloon-pump assisted C oronary I ntervention S tudy . A British Cardiovascular Intervention Society Project. p=0.29. p=0.001. IABP use during high-risk PCI. n=133, elective PCI

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UK Trial Update

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  1. UK Trial Update Simon Redwood Advanced Angioplasty Jan 2006 No Conflict of Interest

  2. BCIS-1 StudyBalloon-pump assisted Coronary Intervention Study A British Cardiovascular Intervention Society Project

  3. p=0.29 p=0.001 IABP use during high-risk PCI n=133, elective PCI Non-randomised trial Briguori et al, Am Heart J 2003

  4. Study Design • Prospective, open, randomised trial • Randomisation to Elective IABP or No Planned IABP • UK study 15-20 centres • Sample size 300 patients • Follow-up to hospital discharge or 28 days after randomisation which ever is sooner • Six month follow-up ONS / GROS BCIS-1

  5. Inclusion Criteria • Impaired LV Function (EF < 30%) • Extensive Myocardium at Risk • LMS Stenosis • Jeopardy Score > 8 Exclusion Criteria • Cardiogenic Shock • STEMI within 48 hours • VSD, MR, Intractable VT/VF • Contraindication to IABP BCIS-1

  6. Primary Outcome • MACE at hospital discharge or 28 days Secondary Outcomes • Mortality at six months • Procedural complications • Procedural success • Bleeding complications • Access site complications • Transient ischaemic attack • Duration of hospital stay BCIS-1

  7. Recruitment at 17th January 2006 1st patient randomised 20th Dec 06

  8. Timelines

  9. BBC ONE The British Bifurcation Coronary study: Old, New and Evolving strategies A randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesions

  10. BBC ONE Inclusion criteria • >18 yrs • Stable or unstable angina • Bifurcation types I-IV suitable for stenting of both vessels • Vessel diameters >2.25mm side, >2.5mm main

  11. BBC ONE • Simple – provisional T-stenting • Following main vessel stenting, the side branch should not be treated further unless there is: • <TIMI 3 flow in the side branch • Severe ostial pinching (>90%) of the side branch • Threatened side vessel closure • Side-branch dissection >type A • Complex – crush or culotte (according to operator preference)

  12. BBC ONE Primary endpoints (9 months) • Death • Target vessel failure • main vessel or side branch TIMI<3 (after vasodilators) on further angiogram • main vessel or side branch undergoes attempted repeat PCI/CABG • Myocardial infarction

  13. TRIAL DESIGN | Patients with bifurcation coronary artery disease requiring PCI (main vessel ≥2.5mm, side branch ≥2.25mm) | RANDOMIZED TO EITHER SIMPLE COMPLEX (Stepwise provisional T-stent) (Total lesion coverage) Primary endpoint: composite at 9 months of death, MI, TVF. No. Patients recruited 88 Steering committee: David Hildick-Smith Rod Stables Nick Curzen Keith Oldroyd BBC ONE Jan 2006 500 patients to be recruited by mid 2007. New centres welcome. Trial started Brighton January 2005 For more information, please see BBC ONE website: http://host.e-dendrite.com/csp/bbcs/FrontPages/bbcs.csp Or david.hildick-smith@bsuh.nhs.uk

  14. BBC ONE recruitment to January 20th 2006

  15. The CARDia TrialCoronary Artery Revascularisation in Diabetes

  16. Study Design • Multi-centre, randomised, prospective comparison of PCI vs CABG for diabetics with MV or complex SVD • ‘Up-to-date’ strategy – DES, 2b3a, Arterial conduits, off-pump, optimum glucose control, etc • Non Inferiority design, target 600 patients Primary endpoint: • Composite event rate at 1 year of death/non-fatal MI/non-fatal stroke Majorsecondary: • Further revascularisation procedures

  17. Diabetic patients with multivessel disease or complex single vessel disease No Suitable for PCI or CABG registry No Inclusion and exclusion criteria met registry No registry CONSENT Randomisation CABG PCI +DES

  18. Glasgow Western Hairmyers James Cook University Blackpool Dublin Liverpool Sheffield Nottingham Birmingham Papworth Bristol LONDON Southampton Brighton CARDiaCentres The 6 centres London are: Hammersmith St Mary’s St Thomas’ Kings College London Chest Harefield

  19. If every centre recruited 1 per month we would finish in 10 months, if 2 then 5 months ! Recruitment So Far !

  20. R-PCI mortality 5.4%

  21. Chest Pain Paramedic Δ AMI REACT 2 Prehospital Thrombolysis 300 mg clopidogrel (CLARITY) 600 mg clopidogrel 90 min ECG < 50% ST resolution > 50% ST segment resolution PPCI MANDATED RESCUE PCI (REACT) Pre-discharge angio (GRACIA)

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