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

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

3. Advanced Angioplasty 2006 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

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

5. Advanced Angioplasty 2006

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.

9. Advanced Angioplasty 2006 LE MANS PCICABG Registry163184 Randomised5253 Age6061 Distal LM5862 DES (<3.8)35%62% LIMA Vessels2.3±0.82.9 ±0.8 Grafts

10. Advanced Angioplasty 2006 Events by 30 days PCICABG Death02ns AMI12ns CVA02ns HF14ns Repeat revasc.01ns Any MACE290.028

11. Advanced Angioplasty 2006 Results OutcomesCABG, n (%)PCI, n (%)p Any MACE (<30 days) 9 (20.7)2 (3.8)0.028 Any MAE (<30 days) 19 (35.8)3 (5.8)0.0001 Any MACE (30 d-12 mo) 11 (20)11 (21)NS

12. Advanced Angioplasty 2006 Ejection Fraction

13. Advanced Angioplasty 2006 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

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

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)

17. Advanced Angioplasty 2006 Senior PAMI Demographics PCILyticp value Age78 ±677 ±60.47 range70-9970-101 Female42%40%0.54 Hypertension65%67%0.65 Diabetes (all T2DM) 25%20%0.22 Impaired mobility 6.1%1.8%0.16 Dementia5.7%0.0%0.0003

18. Advanced Angioplasty 2006 Senior PAMI Presentation PCI (n=252) Lytic (n=229) p value CP to ED (median mins) 1551480.38 CP to Rx (median mins) 237210 (+ reperf. time) 0.014 Infarct: Inferior Anterior/LBBB 49 48 60 41 0.22 0.12 Diuretic in ED8.83.50.018

19. Advanced Angioplasty 2006 PCI Arm Multivessel Disease 2 vessel 3 vessel LM/4 vessel 77% 31.2% 40% 5.6% Initial TIMI:0 1-2 3 80% 12.1% 8.2% No PCI (1 patient died, 13 risky anatomy/LMS, 4 <70%stenosis) 8% Post PCI:TIMI 0 1-2 3 CABG 4.3% 9.6% 86.1% 3.6%

20. Advanced Angioplasty 2006 Thrombolytic Arm Lytic given (99.6%)Streptokinase TNK, tPA, rPA 37.6% 62% Clinical Reperfusion65% Non-protocol Cath: <12hrs In-hospital 21% 51% Non-protocol PCI In-hospital37% CABG4.4%

21. Advanced Angioplasty 2006 Senior PAMI 30 Day Events Disabling CVA Death/ dCVA 0.48 0.26 0.039 0.570.05 %

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

23. Advanced Angioplasty 2006 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

24. Advanced Angioplasty 2006 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?

25. Advanced Angioplasty 2006 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

26. Advanced Angioplasty 2006

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

39. Advanced Angioplasty 2006

40. 30 Day Outcomes: Research/T-Search Pre-DES Group DES Group P* (n=86) (n=95) Death6 (7)10 (11)0.60 Nonfatal MI8 (9)4 (4)0.24 Death/non- fatal MI14 (16)14 (15)0.84 TVR2 (2)0 (0)0.22 Repeated PCI1 (1)0 (0) CABG1 (1)0 (0) Any event16 (19)14 (15)0.56 Stent thrombosis0 (0)0 (0)1 *By Fisher exact test. Angiographically documented. Circulation. 2005 Nov 1;112(18) Valgimigli M et alValgimigli M