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BBC ONE. David Hildick-Smith Sussex Cardiac Centre Brighton, UK on behalf of the BBC ONE Investigators. BBC ONE. The B ritish B ifurcation C oronary study: O ld, N ew and E volving strategies a randomized comparison of simple versus complex
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BBC ONE David Hildick-Smith Sussex Cardiac Centre Brighton, UK on behalf of the BBC ONE Investigators
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
Techniques Simple – stepwise provisional T-stenting Complex – total lesion coverage: crush or culotte (according to operator preference)
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
Inclusion criteria • Bifurcation coronary artery disease requiring stenting • Vessel diameters • ≥2.25mm side • ≥2.5mm main
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%
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.
Technique (simple) • Stage 1 • Stent main vessel
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
Technique (simple) • Stage 2 • Kissing inflation
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
Technique (simple) • Stage 3 • T-stent
Technique (simple) • Mandatory kissing
Technique (complex) • Culotte • wire both vessels • stent first vessel
Technique (complex) • Culotte • Rewire main vessel • stent 2nd vessel • mandatory kissing
Technique (complex) • Crush • stent side vessel • crush with balloon/stent
Technique (complex) • Crush • stent main • recross side • mandatory kissing
PRIMARY ENDPOINT composite at 9 months of: • Death • Target vessel failure • Myocardial infarction
SECONDARY ENDPOINTS • Death • Myocardial infarction • Target vessel failure • Angina status – CCS and Angina index • Repeat angiography
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)
Additional details • Operators >150 PCI/yr • (96% procedures took place at surgical centres) • TAXUS stents • Clopidogrel and Aspirin for 9 months
Recruiting centres Brighton, 116
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)
20% Complex Simple 15% 10% Cumulative percentage 5% 0% 0 3 6 9 Follow-up time (months) MYOCARDIAL INFARCTION p=0.001
TARGET VESSEL FAILURE 20% Complex Simple 15% p=ns 10% Cumulative percentage 5% 0% 0 3 6 9 Follow-up time (months)
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
CONCLUSIONS • Further studies will examine whether there are bifurcation subsets in which total lesion coverage may be advantageous