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BBC ONE

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  1. BBC ONE David Hildick-Smith Sussex Cardiac Centre Brighton, UK on behalf of the BBC ONE Investigators

  2. 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

  3. Techniques Simple – stepwise provisional T-stenting Complex – total lesion coverage: crush or culotte (according to operator preference)

  4. Study organisation • Steering Committee: Curzen, Stables, Oldroyd, Hildick-Smith • Initiation visit: Cooter • Randomisation and data entry: secure e-CRF at www.e-dendrite.com • DSMB: Walsh, Wilcox, Scrase • CEC: Thomas, MacCarthy • Monitoring visit: Cooter, Bennett, Wilson • Data management: Dendrite Clinical Systems • Continous remote monitoring: Cooter, Bennett, Howarth • Statistician: Clayton

  5. Inclusion criteria • Bifurcation coronary artery disease requiring stenting • Vessel diameters • ≥2.25mm side • ≥2.5mm main

  6. Exclusion criteria • Unprotected left main stem narrowing ≥50% • Primary angioplasty • Cardiogenic shock • CTO of either bifurcation-related vessel • Additional Type C or bifurcation lesions requiring PCI • Left ventricular ejection fraction ≤20%

  7. Statistical hypothesis • Assumption: • Death, MI, TVF (at nine months) • 10% vs 20% in the two groups • Sample size of 400 patients would achieve 80% power at a 5% significance level • To allow for patients lost to follow-up and protocol violations it is proposed to recruit 500 patients to the study.

  8. Technique (simple) • Stage 1 • Stent main vessel

  9. Technique (simple) • 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 • if any of these applies, the operator may → Stage 2

  10. Technique (simple) • Stage 2 • Kissing inflation

  11. Technique (simple) • Following kissing inflations, the side branch should not be treated further unless there is: • <TIMI 3 flow in the side branch • Severe ostial pinching (>70%) of the side branch • Threatened side vessel closure • Side-branch dissection >type A • if any of these applies, the operator may → Stage 3

  12. Technique (simple) • Stage 3 • T-stent

  13. Technique (simple) • Mandatory kissing

  14. Technique (complex) • Culotte • wire both vessels • stent first vessel

  15. Technique (complex) • Culotte • Rewire main vessel • stent 2nd vessel • mandatory kissing

  16. Technique (complex) • Crush • stent side vessel • crush with balloon/stent

  17. Technique (complex) • Crush • stent main • recross side • mandatory kissing

  18. PRIMARY ENDPOINT composite at 9 months of: • Death • Target vessel failure • Myocardial infarction

  19. SECONDARY ENDPOINTS • Death • Myocardial infarction • Target vessel failure • Angina status – CCS and Angina index • Repeat angiography

  20. PROCEDURAL ENDPOINTS • Procedural success • TIMI 3 flow and <30% stenosis main vessel, and • TIMI 3 flow side branch • Kissing balloons success • In-hospital MACE • In-hospital serious adverse events (non-MACE) • Procedure duration, fluoroscopy, cGy.cm2, contrast • Procedural consumables (wires, balloons, stents)

  21. Additional details • Operators >150 PCI/yr • (96% procedures took place at surgical centres) • TAXUS stents • Clopidogrel and Aspirin for 9 months

  22. Recruitment

  23. Recruiting centres Brighton, 116

  24. RESULTS

  25. Baseline characteristics

  26. Clinical presentation

  27. Site of bifurcation lesion

  28. Bifurcation types (MEDINA)

  29. Glycoprotein IIb/IIIa use

  30. Lesion and stent characteristics

  31. Lesion and stent characteristics

  32. Lesion and stent characteristics

  33. SIMPLE

  34. COMPLEX (Culotte)

  35. COMPLEX (Crush)

  36. PRIMARY ENDPOINTComposite (9months) Death, MI, TVF

  37. PRIMARY ENDPOINTDeath, MI, TVF 20% Complex Simple 15% p=0.009 Cumulative % death, MI, TVF 10% 5% 0% 0 3 6 9 Follow-up time (months)

  38. 20% Complex Simple 15% 10% Cumulative percentage 5% 0% 0 3 6 9 Follow-up time (months) MYOCARDIAL INFARCTION p=0.001

  39. Biomarker data

  40. TARGET VESSEL FAILURE 20% Complex Simple 15% p=ns 10% Cumulative percentage 5% 0% 0 3 6 9 Follow-up time (months)

  41. Target vessel failure

  42. In-hospital MACE

  43. In-hospital serious adverse events(non-MACE)

  44. Procedural endpoints

  45. CONCLUSIONS • For unselected bifurcation lesions, a stepwise provisional T stent strategy is superior to a systematic dual stenting strategy in all domains: • procedural success • procedural complications • in-hospital and 9-month MACE

  46. CONCLUSIONS • Further studies will examine whether there are bifurcation subsets in which total lesion coverage may be advantageous