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Bifurcation PCI and UK Trial Update

Bifurcation PCI and UK Trial Update. Rosie Swallow Royal Bournemouth Hospital. No conflicts of interest. Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions. The Nordic Bifurcation Study . Circulation . 2006;114: 1955-1961. Background.

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Bifurcation PCI and UK Trial Update

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  1. Bifurcation PCI and UK Trial Update Rosie Swallow Royal Bournemouth Hospital

  2. No conflicts of interest

  3. Randomized Study on Simple Versus Complex Stenting of Coronary Artery Bifurcation Lesions. The Nordic Bifurcation Study Circulation. 2006;114: 1955-1961

  4. Background • Optimal stenting strategy in coronary artery bifurcation lesions is unknown • Sirolimus coated stents reduce the rate of restenosis in simple and complex coronary artery lesions

  5. Nordic Bifurcation Study • Non blinded • Randomised • Multi-centre • 28 cardiology centres – Denmark, Sweden, Finland, Norway and Latvia • September 2004 – May 2005

  6. Aim Compare two stenting strategies in de novo bifurcation lesions using Sirolimus Eluting Stents (SES): I. Stenting Main Vessel and optional stenting of side branch (MV) II. Stenting Main Vessel and Side Branch (MV+SB)

  7. Randomised patients (n:413) Stenting main vessel only (MV) (n: 207) Stenting main vessel and side branch (MV+SB) (n: 206) Clinical Follow up, 6 months (n: 207) Clinical Follow up, 6 months (n: 206) Scheduled angiographic Follow up after 8 months (n: 176) Scheduled angiographic Follow up after 8 months (n: 182) Angiographic Follow up available (n: 151) Angiographic Follow up available (n: 156)

  8. Inclusion criteria • Stable or unstable AP or silent ischemia • Bifurcation lesion (including LMS in RCA dominant) • Diameter of main vessel by visual estimate ≥2.5 mm • Diameter of side branch by visual estimate ≥2.0 mm

  9. Exclusion criteria • ST- elevation AMI within 24 hours • Expected survival <1year • Serum creatinine >200 μmol/l • Allergy to aspirin, clopidogrel or ticlopidine • Allergy to sirolimus • Left main bifurcation in a non-right dominant system

  10. Primary end points Combined end point at 6 months of : • Cardiac death • Myocardial infarction • Stent thrombosis • Target vessel revascularisation

  11. Secondary end points • Combined end point of cardiac death, index lesion MI, target lesion revascularization (TLR), stent thrombosis • Procedure related biomarker increase • Angiographic follow-up after 8 months

  12. AA 2007

  13. AA 2007

  14. AA 2007

  15. AA 2007

  16. AA 2007

  17. QCA Analysis at 8/12 307 patients MV MV+SB p (n:151) (n:156) MLD SB (mm) 1.52 ± 0.58 1.86 ± 0.60 <0.001 late lumen loss SB (mm) -0.04 ± 0.52 0.2 ± 0.57 <0.001 Restenosis MV (%) 4.6 5.1 0.84 Restenosis SB(%) 19.2 11.5 0.062

  18. Study Limitations • Open design • No ischaemia testing • Underpowered given low MACE rate • Variety of lesion types and locations • Clinical follow up at 6/12 • Angiography at 8/12 • Long term results not known

  19. Conclusions • Excellent 6/12 clinical and 8/12 angiographic results • Procedural success rates high, MACE low, angiographic restenosis low, independent of stenting strategy • Reduced procedure and fluoroscopy times, reduced contrast and reduced risk of biomarker elevation in simple strategy • Simple strategy recommended as routine for bifurcations

  20. Balloon-pump assisted Coronary Intervention Study (BCIS-1)Study Update A British Cardiovascular Intervention Society Project Funded by Datascope, Cordis and Lilly

  21. Study Design • Prospective, open, multi centre, randomised trial • Randomisation to Elective IABP or No Planned IABP • Sample size 300 • Follow-up to hospital discharge or 28 days after randomisation • Six month follow-up ONS / GROS

  22. Main Eligibility Criteria - Inclusion • Proposed single or multi-vessel PCI • Presence of both the following • EF<30% • Large area of myocardium at risk (one of the following) • Unprotected LMS target lesion • Jeopardy score ≥8 • Target vessel provides collateral supply to an occluded 2nd vessel which supplies > 40% myocardium

  23. Main Eligibility Criteria - Exclusion • Systolic BP<85mmHg despite correction of hypovolaemia • Acute MI within previous 48 hours • Planned staged PCI within 28 days of index PCI • CI to IABP

  24. Primary Outcome MACE at hospital discharge or 28 days Secondary Outcomes Mortality at 6/12 Procedural complications Bleeding complications Access site complications Outcomes

  25. BCIS-1 Study Recruitment at 19th January 2006 Total 88 patients

  26. BCIS-1 Projected Study Recruitment Average recruitment per site last 4 months is 0.7pts/month End Feb 2008 End Sep 2008

  27. Study Timelines

  28. Join BCIS-1Centres - Contacts Rod Stables rod.stables@ctc.nhs.uk Simon Redwood simon.redwood@gstt.nhs.uk Divaka Perera divaka.perera@gstt.nhs.uk Jean Booth j.booth@rbht.nhs.uk

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

  30. 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

  31. 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

  32. 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

  33. No. Patients recruited 310 BBC ONE January 1st 2007 Steering committee: David Hildick-Smith Rod Stables Nick Curzen Keith Oldroyd

  34. BBC ONErecruitment to January 1st 2007(Ethics-approved centres)

  35. BBC ONEcurrent and target recruitment January 1st 2007

  36. Study Timelines • Regulatory Approval (COREC/MHRA)  Nov 2004 • Pilot Study (Brighton Site Only)        Jan  2005 • First Wave of UK Sites recruiting    Nov 2005 • 1st Interim analysis (220 pts)         Sep 2006 • 2nd Interim analysis (350 pts) • Final patient recruited                     July 2007 • Follow up complete                       Mar 2008 • Presentation                                  May 2008

  37. BBC 1 Contacts David Hildick Smith david.hildick-smith@bsuh.nhs.uk Nina Cooter Nina.Cooter@bsuh.nhs.uk

  38. The CARDia TrialCoronary Artery Revascularisation in Diabetes

  39. Study Design • Multi-centre, randomised, prospective comparison of PCI vs CABG for diabetics with MV or complex SVD • ‘Up-to-date’ strategy – DES, GPIIbIIIa, Arterial conduits, off-pump, optimum glucose control • Non Inferiority design, target 600 patients, revised to 500 Dec 2006

  40. 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

  41. Primary endpoint: • Composite event rate at 1 year of death/non-fatal MI/non-fatal stroke Majorsecondary endpoint: • Further revascularisation procedures • Follow up is at 30 days, 6 months, 1 year, 2 years

  42. Glasgow Western Hairmyers James Cook University Blackpool Dublin Liverpool Sheffield Nottingham Birmingham Papworth Bristol LONDON Southampton Brighton CARDia Centres The 8 centres London are: Hammersmith St Mary’s St Thomas’ Kings College London Chest Harefield St Bart’s Royal Brompton Manchester Stoke

  43. Recruitment

  44. Study Timelines • MREC approval was granted August 2001 • First sites activated January 2002 • Plan to finish recruitment April 2007 • Application for additional funding to support follow up at 5 years.

  45. CARDia Contacts • Co-chief Investigator and Chairman of Steering Committee - Prof Roger Hall (Norfolk and Norwich and Hammersmith Hospitals) • Co-chief investigator and Project Manager - Dr Akhil Kapur (London Chest Hospital) • Director CTEU - Dr Marcus Flather (Royal Brompton Hospital) • Study co-ordinator - Nicola Delahunty (CTEU, Royal Brompton Hospital) • Study has been managed by CTEU at the Royal Brompton Hospital since April 2006. Prior to this time it was managed at the Hammersmith Hospital.

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