advanced angioplasty 2006 trial update 2 other trials alun harcombe from 1 april: nottingham...
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Advanced Angioplasty 2006
Trial Update 2Other Trials
Alun Harcombe
from 1 April: Nottingham University Hospitals NHS Trust
NO CONFLICT OF INTEREST TO DECLARE
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
Advanced Angioplasty 2006
LE MANS
• Dr Pawel Buszman
Silesian Medical School, Katowice, Poland
• First Randomised Trial in Modern Era:
Unprotected LMS Stenting vs CABG
Advanced Angioplasty 2006
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
LE MANS
PCI CABGRegistry 163 184Randomised 52 53Age 60 61Distal LM 58 62DES (<3.8) 35% 62% LIMAVessels 2.3±0.8 2.9 ±0.8 Grafts
Advanced Angioplasty 2006
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 90.028
Advanced Angioplasty 2006
Results
Outcomes CABG, 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
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
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
Advanced Angioplasty 2006
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
Senior PAMI Demographics
PCI Lytic p valueAge 78 ±6 77 ±6 0.47
range 70-99 70-101
Female 42% 40% 0.54
Hypertension 65% 67% 0.65
Diabetes (all T2DM)
25% 20% 0.22
Impaired mobility
6.1% 1.8% 0.16
Dementia 5.7% 0.0% 0.0003
Advanced Angioplasty 2006
Senior PAMI PresentationPCI
(n=252)Lytic
(n=229)p value
CP to ED
(median mins)
155 148 0.38
CP to Rx
(median mins)
237 210(+ reperf. time)
0.014
Infarct: Inferior
Anterior/LBBB
49
48
60
41
0.22
0.12
Diuretic in ED 8.8 3.5 0.018
Advanced Angioplasty 2006
PCI ArmMultivessel 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%
Advanced Angioplasty 2006
Thrombolytic Arm
Lytic given (99.6%) Streptokinase
TNK, tPA, rPA
37.6%
62%
Clinical Reperfusion 65%
Non-protocol Cath: <12hrs
In-hospital
21%
51%
Non-protocol PCI In-hospital 37%
CABG 4.4%
Advanced Angioplasty 2006
Senior PAMI 30 Day Events
10
13
0.82.2 1.6
5.4
11.313
11.6
18
0
2
4
6
8
10
12
14
16
18
Death ReMI D/CVA/ReMI
PCI (n=252)
Lytic (n=229)
DisablingCVA
Death/dCVA
0.48 0.26
0.039
0.57 0.05
%
Advanced Angioplasty 2006
Senior PAMI 30 Day Events by Age
7.1
11.3
7.7
12
7.7
17
0
5
10
15
20
25
%
Death Death/CVA D/CVA/reMI
PCI Lytic
19
16
20
16
22 22
0
5
10
15
20
25
%
Death D/CVA D/CVA/reMI
PCI Lytic
0.0093
70-80yrs (n=381) >80yrs (n=130)
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
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?
Advanced Angioplasty 2006
Proximal Trial
Proximal Protection during Saphenous Vein Graft Intervention using the Proxis Embolic Protection System: A Randomised Prospective Multicenter Trial
Campbell RogersBrigham and Womens Hospital, Boston
Advanced Angioplasty 2006
Conclusions
• Left main stenting – here to stay
• Primary PCI – up to 80yrs age
• Proxis – good for embolic protection in
distal lesions
Advanced Angioplasty 2006
30 Day Outcomes: Research/T-Search
Pre-DES Group DES Group P* (n=86) (n=95)
Death 6 (7) 10 (11) 0.60Nonfatal MI 8 (9) 4 (4) 0.24Death/non- fatal MI 14 (16) 14 (15) 0.84TVR 2 (2) 0 (0) 0.22Repeated PCI 1 (1) 0 (0)CABG 1 (1) 0 (0)Any event 16 (19) 14 (15) 0.56Stent thrombosis 0 (0) 0 (0)1
*By Fisher exact test. Angiographically documented.
Circulation. 2005 Nov 1;112(18) Valgimigli M et al
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