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Advanced Angioplasty 2006 Trial Update 2 Other Trials Alun Harcombe from 1 April: Nottingham University Hospitals NHS Trust NO CONFLICT OF INTEREST TO DECLARE
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Advanced Angioplasty 2006 Other Trials LE MANS SENIOR PAMI PROXIMAL
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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
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Advanced Angioplasty 2006 LE MANS Dr Pawel Buszman Silesian Medical School, Katowice, Poland First Randomised Trial in Modern Era: Unprotected LMS Stenting vs CABG
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Advanced Angioplasty 2006
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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.
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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
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Advanced Angioplasty 2006 Events by 30 days PCICABG Death02ns AMI12ns CVA02ns HF14ns Repeat revasc.01ns Any MACE290.028
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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
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Advanced Angioplasty 2006 Ejection Fraction
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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
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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
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Advanced Angioplasty 2006
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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)
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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
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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
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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%
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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%
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Advanced Angioplasty 2006 Senior PAMI 30 Day Events Disabling CVA Death/ dCVA 0.48 0.26 0.039 0.570.05 %
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Advanced Angioplasty 2006 Senior PAMI 30 Day Events by Age 0.0093 70-80yrs (n=381)>80yrs (n=130)
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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
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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?
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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
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Advanced Angioplasty 2006
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Conclusions Left main stenting – here to stay Primary PCI – up to 80yrs age Proxis – good for embolic protection in distal lesions
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Advanced Angioplasty 2006
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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
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