OCTOBER. OCT Optimised Bifurcation Event Reduction. A Nordic Baltic British clinical outcome trial

Transcription

1 OCT Optimised Bifurcation Event Reduction A Nordic Baltic British clinical outcome trial NIELS RAMSING HOLM, Skejby Denmark

2 Study start: OCTOBER 2016 OCTOBER LMCA or non-lmca bifurcations with SB 2.5mm Need for rewiring a stent during treatment 1:1 randomization of 1200* patients *Adaptive design OCT guiding Systematic treatment protocol Standard guiding Angiographic guiding IVUS optional Primary endpoint: Two-year MACE for superiority 10-year follow-up Only clinical follow-up, Skejby Denmark

3 Aims 1. To determine if OCT-guiding in complex bifurcation treatment provides superior clinical outcome in comparison to standard guiding by angiography and optional IVUS 2. To provide interested operators a systematic approach for use of OCT during complex PCI, Skejby Denmark

4 WhyOCTfor complex bifurcation stenting? 1. High risk lesion subset 2. High level of angiographic ambiguity 3. OCT identifies multiple correctable factors, Skejby Denmark

5 OCT enables evaluation of: Pre-dilatation/ plaque modification Sizing and positioning for stents and balloons Lesion coverage Wire positions Expansion and stent apposition, Skejby Denmark

6 European Heart Journal, October 2014, Skejby Denmark

7 FFR FFR RADI wire NEJM: FFR DEFER FAME 1 FAME OCT In human M2 C7 OPTIS i, Skejby Denmark

8 Study start: OCTOBER 2016 OCTOBER LMCA or non-lmca bifurcations with SB 2.5mm Need for rewiring a stent during treatment 1:1 randomization of 1200* patients *Adaptive design OCT guiding Systematic treatment protocol Standard guiding Angiographic guiding IVUS optional Primary endpoint: Two-year MACE for superiority 10-year follow-up Only clinical follow-up, Skejby Denmark

9 Primary endpoint Two-year composite of MACE Cardiac death Target lesionmi Ischemia driven TLR Target bifurcation + other stented lesions Secondary endpoint Two-year target bifurcation MACE Cardiac death Target bifurcation myocardialinfarction Target bifurcation revascularization Target bifurcation, Skejby Denmark

10 Secondary endpoints: Individual clinical endpoints Post PCI segmental MLA, 3D QCA Use of contrast Fluouro time Procedure time All cause mortality Cardiac death MI TL-MI TVR TLR Stent thrombosis Ressource utilization, Skejby Denmark

11 Sample size calculation for superiority Assumptions: 60% distal left main bifurcations 30% patients with multivesseldisease Xience level DES performance Event rates - population: SYNTAX, MAIN COMPARE, NORDIC III, MITO registry, CORPAL registry Event reduction estimates: CLI-PCI study, CLI-PIC II, IVUS-XPL Alpha 0.05, power 80% Estimated event rates at 2 years are 16% by standard guiding and 10% by OCT guiding. Thus 984 patients are required for adequate statistical power. Inclusion target is 1200 patients., Skejby Denmark

12 Inclusion criteria Bifurcation lesion Indication for treatment of the side branch Side branch ref. diameter 2.5mm Exclusion criteria STEMI Cardiogenic shock Severe renal failure Other complex bifurcations, CTO Inability to wire both vessels Angiographic exclusion criteria, Skejby Denmark

13 Broad in- and exclusion criteria allows for inclusion of: - all main vessel and side branch lesion lengths - all bifurcations including distal left main - patients with multi vessel disease, Skejby Denmark

14 Study treatment One-stent techniquewith POT, kissing, POT Two-stent techniques, except Mini crush Classic crush SKS technique No SB access after stenting in ~15-20% of cases Long metallic carina, Skejby Denmark

15 Treatment goals by OCT guiding Full lesion coverage Optimal vessel/stent expansion Complete stent apposition, Skejby Denmark

16 Simple stenting 1. Predilatation Check lesion preparation Sizing, positioning of stent and POT balloon 2. Stent implantation, 1st POT and rewiring distal stent cell Full lesion coverage Expansion and apposition Wire position (in recrossing and excluding abluminal rewiring) 3. Kissing balloon inflation and POT Expansion and apposition Side branch ostium, Skejby Denmark

17 Complex stenting Study procedures with OCT are detailed in protocol for: Culotte T-stenting TAP DK-crush, Skejby Denmark

18 1. Predilatation 2. Check lesion preparation 3. Sizing, positioning of stent and POT balloon 4. Stent implantation, 1st POT and rewiring mid stent cell 5. Full lesion coverage. Edge check. 6. Expansion and apposition 7. Wire position (+ a 3rd pullback if more than one rewiring) 8. Kissing balloon inflation and POT 9. Expansion and apposition 10. Side branch lesioncoverage Complex stenting General principles, Skejby Denmark

19 Holm NR, Santos I et al in preparation, Skejby Denmark

20 Training in OCT guiding before study enrollment On-site instructions: OCT treatment principles Acquistion technique Image interpretation Measurements Practical setup for feasible study procedures, Skejby Denmark

21 OCT guiding procedures are uploaded immediatly to the corelab for review Next day feedback for continuous training, Skejby Denmark

22 Academic trial, Skejby Denmark

23 Academic trial Study grants from St. Jude Medical and Abbott, Skejby Denmark

24 National coordinators Sweden: Nils Witt, Södersjukhuset, Stockholm Norway: Christian Eek, Oslo University Hospital Finland: Olli Kajander, Tampere University Hospital UK: Latvia: Simon Walsh, Belfast University Hospital Indulis Kumsars, Latvian Heart Centre, Riga Estonia: Peep Laanmets, North Estonia Medical Center, Tallin Denmark: Evald Høj Christiansen,, Skejby Denmark

25 , Skejby Denmark

26 THANK YOU LMCA or non-lmca bifurcations with SB 2.5mm Need for rewiring a stent during treatment 1:1 randomization of 1200* patients *Adaptive design OCT guiding Systematic treatment protocol Standard guiding Angiographic guiding IVUS optional Primary endpoint: Two-year MACE for superiority 10-year follow-up Only clinical follow-up evald.christiansen@dadlnet.dk or, Skejby Denmark