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Trial Update 2

Trial Update 2. Other Trials Alun Harcombe. from 1 April: Nottingham University Hospitals NHS Trust. NO CONFLICT OF INTEREST TO DECLARE. Other Trials. LE MANS SENIOR PAMI PROXIMAL. Early Conclusion.

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Trial Update 2

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  1. Trial Update 2 Other Trials Alun Harcombe from 1 April: Nottingham University Hospitals NHS Trust NO CONFLICT OF INTEREST TO DECLARE Advanced Angioplasty 2006

  2. Other Trials • LE MANS • SENIOR PAMI • PROXIMAL Advanced Angioplasty 2006

  3. Early Conclusion • Left Main Stenting Safe and Feasible, might avoid some morbidity and improve ejection fraction • Elderly patients do quite badly with heart attacks – however managed, unless they’re not that elderly • Proximal protection for vein grafts is quite good when it is possible and it works Advanced Angioplasty 2006

  4. LE MANS • Dr Pawel Buszman Silesian Medical School, Katowice, Poland • First Randomised Trial in Modern Era: Unprotected LMS Stenting vs CABG Advanced Angioplasty 2006

  5. Advanced Angioplasty 2006

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  8. LE MANS Endpoints • Primary: • LVEF • functional capacity • angina status (12 months) • Secondary • major adverse cardiac events (MACE) • hospital length of stay • survival • any major adverse events (MAEs) • any MACE, procedure-related infection, bleeding, or renal or respiratory insufficiency. Advanced Angioplasty 2006

  9. LE MANS PCI CABG Registry 163 184 Randomised 52 53 Age 60 61 Distal LM 58 62 DES (<3.8) 35% 62% LIMA Vessels 2.3±0.8 2.9 ±0.8 Grafts Advanced Angioplasty 2006

  10. Events by 30 days PCI CABG Death 0 2 ns AMI 1 2 ns CVA 0 2 ns HF 1 4 ns Repeat revasc. 0 1 ns Any MACE 2 9 0.028 Advanced Angioplasty 2006

  11. Results Advanced Angioplasty 2006

  12. Ejection Fraction Advanced Angioplasty 2006

  13. Comments • LV function estimates • not blinded • applies if LV impaired to begin with? • Low rate of DES usage • Small single centre study • LMS stenting a reasonable option? • The era of data has begun Advanced Angioplasty 2006

  14. Senior PAMI • Senior Primary Angioplasty in Myocardial Infarction: International multi-centre randomised • Dr Cindy Grines William Beaumont Hospital Royal Oak Michigan USA Advanced Angioplasty 2006

  15. Advanced Angioplasty 2006

  16. Senior PAMI • Aged ≥70years • Acute MI symptoms 30 minutes to 12 hours • 1mm ST elevation, or LBBB • Eligible for lytic therapy • Excluded: • SBP >180 mm Hg or DBP>100 mm Hg • Warfarin, INR>1.4 • Cardiogenic shock • Randomised to Thrombolysis or Transfer to Cardiac Catheter Laboratory for PCI • International, multi-centre • Stopped early (slow recruitment, 47 short of 530) Advanced Angioplasty 2006

  17. Senior PAMI Demographics Advanced Angioplasty 2006

  18. Senior PAMI Presentation Advanced Angioplasty 2006

  19. PCI Arm Advanced Angioplasty 2006

  20. Thrombolytic Arm Advanced Angioplasty 2006

  21. Senior PAMI 30 Day Events % 0.039 0.48 0.26 0.57 0.05 Disabling CVA Death/ dCVA Advanced Angioplasty 2006

  22. Senior PAMI 30 Day Events by Age 0.0093 70-80yrs (n=381) >80yrs (n=130) Advanced Angioplasty 2006

  23. Conclusions • Primary PCI effective at reducing combined endpoint, but not primary endpoint of death or disabling stroke • In sub-group of very elderly PCI may have no advantage at all • Lysis followed by rescue where needed? • Main PCI advantages: • Avoid intracranial bleeding • Reduce re-infarction & recurrent ischaemia Advanced Angioplasty 2006

  24. Points • Selected population, slow recruitment • No prior CVAs • Warfarin and hypertension exclusions • Event rates low in lytic arm • Lower dose heparin regimes (60u/kg, max 4000u) • High rates of invasive investigation, rescue and later PCI (&CABG) in lytic arm • Lytic ineligible patients? Advanced Angioplasty 2006

  25. Proximal Trial Proximal Protection during Saphenous Vein Graft Intervention using the Proxis Embolic Protection System: A Randomised Prospective Multicenter Trial Campbell Rogers Brigham and Womens Hospital, Boston Advanced Angioplasty 2006

  26. Advanced Angioplasty 2006

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  38. Conclusions • Left main stenting – here to stay • Primary PCI – up to 80yrs age • Proxis – good for embolic protection in distal lesions Advanced Angioplasty 2006

  39. Advanced Angioplasty 2006

  40. 30 Day Outcomes: Research/T-Search Pre-DES Group DES Group P* (n=86) (n=95) Death 6 (7) 10 (11) 0.60 Nonfatal MI 8 (9) 4 (4) 0.24 Death/non- fatal MI 14 (16) 14 (15) 0.84 TVR 2 (2) 0 (0) 0.22 Repeated PCI 1 (1) 0 (0) CABG 1 (1) 0 (0) Any event 16 (19) 14 (15) 0.56 Stent thrombosis 0 (0) 0 (0)1 *By Fisher exact test. Angiographically documented. Circulation. 2005 Nov 1;112(18) Valgimigli M et al Advanced Angioplasty 2006

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