The Trans Radial Intervention and Patient Subsets (I)

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The Trans Radial Intervention and Patient
Subsets (I)

• The Very Old and The Very Sick Octogenerians,
  Acute Coronary Syndromes

M.Heigert Landeskrankenhaus Salzburg Bad Gastein
10.02.2007
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Europes Old Age Epidemia
2004
2050
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City and country of Salzburg 2004 ? when compared to 1999
population 524.404 2,4
60 years (m/f) 104.251 (43/57) 15,8
? 75 years 35.495
Current life expectancy for 60 year males 21,8 9,3
Current life expectancy for 60 year females 24,8 2,9
20 of Europes population will be over 80 in the
year of 2050
Current life expectancy 82 - 85 years
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CHD in Salzburg 2004 - 2006 (without valves)
diagnostic procedures in different age groups
39,2 aller Koronarpatienten gt70
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Salzburg 2004-2006 valve-diseases pre-op
diagnostic coronary angiogram n216
57,9 aller Klappenpatienten über 70, 18 über
80
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Euro Heart Service on PCI 2006 n13151
gt 75
lt 75
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Implications of old age

• Reduced life expectancy
• Reduced physiologic reserves
• Higher comorbidities
• peripheral artery disease
• renal insufficiency
• diabetes
• lung diseases / COAD
• complex CHD
• Higher risks

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EHS 2006 risk-profile in the elderly
gt75n2427 lt75 n10725
Med. age 79 61
Hypertension 75 64
Hyperlipid. 56 64
Smoking 8 33
Diabetes 28 25
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PCI in Elderly cardiovascular history
EHS 2006
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PCI in Elderly urgency
STEMI 18/18, NSTEMIEHS 2006 16/12, UAP 8/6
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Number of diseased vessels
Dsignificantly more 3-VD in the elderly EHS
2006. häufiger
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Salzburg January - June 2006
ACS patients ?75 years n 137
Salzburg 1-9/06
Mean age female LM 3G 2G 1G ns
80,05 3,4 69 (50,4) 11 (8) 53 (38,6) 28 (20,4) 37 (27) 8 (5,8)
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Trial of Invasive vs. Medical Therapy in Elderly
Patients With Chronic Symptomatic Coronary-Artery
Disease (TIME) A Randomized Trial
148 pts aged 75 years or older with chronic
angina of Canadian Cardiac Society class II or
more despite treatment with ?2 antianginal drugs
were assigned to medical therapy and 153 to
invasive therapy. Primary end points were
quality of life and a composite of death,
nonfatal MI, or hospital admission for ACS at 6
months.
Vs. Baseline Invasive Medical p-Value
General health 11.4 3.8 .008
Bodily pain 31.3 23.6 .12
Vitality 10.6 6.1 .16
Number of angina medications -1.0 -0.2 lt.0001
Duke activity score index 7.2 5.3 .17
Rose pain score -1.9 -1.1 .008
Angina pectoris class -2.0 -1.6 .01
MACE 19 49 lt.0001

Conclusion Pts aged 75 or older with angina
despite standard drug therapy benefit more from
revascularization than from medical therapy.
The TIME Investigators, Lancet2001358951-957.
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PCI Inhosp. Outcome in old aged patients
EHS 2006
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The REPLACE-2 Trial (N6010)Trial Design
6010 Urgent or elective PCI patients
Aspirin Clopidogrel Stent
Endpoints 30-day Death MI Revasc Hemorrhage Econ
omics 6, 12m follow up
Bivalirudin Provisional GPIIb/IIIa
2999
Heparin 65 U/kg
Abciximab or Eptifibatide
3011
Lincoff AM, et al. JAMA 2003 289 853-863.
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The REPLACE-2 Trial (N6010)Primary Endpoint at
30 Days
p 0.324
p 0.255
p 0.430
p 0.435
p lt 0.001
of patients
Major bleeding

• Intracranial, intraocular, or retroperitoneal
• Observed bleed with fall in Hgb gt3g/dL
• No observed bleed with fall in Hgb gt4g/dL
• Transfusion ?2 units PRBC or whole blood

Lincoff AM, et al. JAMA 2003 289 853-863.
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The REPLACE-2 Trial (N6010)Major Bleeding and
Mortality in PCI

Feit F, Voeltz MD, Attubato MA, et al.
Unpublished.
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The REPLACE-2 Trial (N6010)Bleeding and
Transfusion by Age
plt0.0001
plt0.0001
Voeltz MD. et al. Circulation 2005112(17)II-613.
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The REPLACE-2 Trial (N6010)Mortality Among
Elderly by Bleeding Status
plt0.01
plt0.01
plt0.01
Mortality
Nelson MA, et al. AHA 2006.
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The REPLACE-2 Trial (N6010)Mortality with
Transfusion in PCI
Non-transfused
Transfused
plt0.0001
Manoukian SV, Voeltz MD, Attubato MJ, Bittl JA,
Feit F, Lincoff AM. CRT 2005.
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The REPLACE-2 Trial (N6010)Predictors of Major
Bleeding in PCI
Variable OR 95 CI p-value
Baseline risk factors
Age 75 1.482 1.01, 2.18 0.045
Gender (Female) 1.535 1.12, 1.10 0.007
Creatinine Clearance 1.008 1.00, 1.01 0.006
Anemia 1.403 1.02, 1.94 0.040
Prior Angina 1.589 1.08, 2.35 0.02
Prior PCI 0.629 0.45, 0.88 0.007
Prior Thienopyridine 0.601 0.39, 0.93 0.023
Peri-procedural risk factors
Treatment Group (Heparin GPI vs. bivalirudin) 1.969 1.37, 2.84 0.0003
Provisional GPI received 2.679 1.59, 4.51 0.0002
Procedure Duration gt1h 2.049 1.22, 3.45 0.007
Time to Sheath Removal gt6h 1.614 1.06, 2.45 0.024
Intensive Care Unit stay (days) 1.25 1.18, 1.32 lt0.0001
Intra-aortic Balloon Pump 8.705 3.43, 22.07 lt0.0001
Feit F, Voeltz MD, Attubato MA, et al.
Unpublished.
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The REPLACE-2 Trial (N6010)Predictors of
One-Year Mortality in PCI
Variable OR (95CI) p-value
Age 75 2.28 (1.51, 3.46) 0.0001
Pre-procedural Anemia 2.12 (1.49, 3.13) 0.0002
BMI gt 25 (vs. 20-25) 0.61 (0.40, 0.99) 0.007
Pre-procedure LVEF 50 2.15 (1.44, 3.21) 0.0002
CHF 3.58 (2.27, 5.65) lt.0001
Prior Angina 2.16 (1.25, 3.75) 0.006
Major Bleeding 2.66 (1.44, 4.92) 0.002
MI 2.46 (1.44, 4.20) 0.001
Revascularization 3.30 (1.36, 8.00) 0.008
Major Bleeding REPLACE-2

• Intracranial, retroperitoneal
• Observed bleed with fall in Hgb ?3g/dL
• No observed bleed with fall in Hgb ?4g/dL
• Transfusion ?2 units PRBC or whole blood

Voeltz MD, Patel AD, press. Feit F, et al. Am J
Cardiol, in
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Concl.

• 3/4 of the old age patients gt75 years gt 2VD
• 2/3 of these patients are only intervened at one
  vessel (incomplete)
• Even more than in younger patients the
  PCI-interventions is good for palliation
• Higher mortality in this high risk group
• Mortality and reinfarctions mainly correlate with
  the high bleeding risk and other vascular
  complications caused at the entry site