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Revascularisation for Claudication: When is it indicated, when not?
Markus Haumer
Landesklinikum Baden-Mödling
Austria
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Disclosure
Speaker name:
Markus Haumer, MD
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
✔
Disclosure
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↓QUALITY
QUALITY OF LIFE
EXERTIONAL
LEG PAIN
ROLE FUNCTIONING
↑RISK
ADVERSE
CARDIOVASCULAR
EVENTS
PREMATURE DEATH
LIMB LOSS
What a claudicant faces
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Too Much Sitting Increases
Mortality Risk
René Magritte (1951) Perspective I
Lynch BM et al. Ann Int Med 2015:146-7.
• Evidence shows that sedentary
behaviour contributes to
• All-cause death
• Cardiovascular death
• Cancer death
• Incidence of cardiovascular
disease, cancer, and type 2
diabetes
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Jacques-Louis David (1800) Madame Récamier
Lynch BM et al. Ann Int Med 2015:146-7.
• Minimize the amount of time
spent in prolonged sitting
• Break up long periods of sitting
as often as possible
• Accumulate 150 to 300 minutes of
moderate intensity physical activity
or...equal..., each week.
Too Much Sitting Increases
Mortality Risk
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...but Johnny Walker is still alive!
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Exertional Leg Symptoms Comorbidities in Claudicants
Lumbar disc disease: 36%1
Spinal stenosis: 11%2
Hip arthritis 4%2
Knee arthritis: 12%1
1McDermott MM et al. Circulation
2008;117:2484-91.
2McDermott MM et al. J Vasc Surg
2005;42:1131-7.
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[mmHg]
140 0 50 (70)
Ankle Pressure
Fontaine Stage
I III IIa IIb IV
0 4 1 3 5 2 6
Chronic Limb Ischemia Definitions
0.9 0.0
Ankle Brachial Index
Rutherford Category
Asympt. Critical Limb Ischemia Claudication
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Claudication Definitions
Fontaine Stage
IIa IIb
1 3 2
Rutherford Category
Mild
Completes
treadmill exercise
AP* after exercise
>50mmHg but
≥20mmHg lower
than resting value
Moderate
Between
Categories 1 and 3
Severe
Cannot complete
treadmill exercise
and
AP* after exercise
<50mmHg
*AP...Ankle pressure Rut
herf
ord
RB
et a
l.
J V
asc
Sur
g 19
97;2
6:51
7-38
.
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Fontaine Stage
IIa IIb
1 3 2
Claudication Definitions
Rutherford Category
Max. Walking Distance
Quality of Life
±500m ±100m
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Events in Claudicants 15 Year Study of 2.777 Veterans
Muluk JC et al. J Vasc Surg 2001;33:251-8.
• Mortality rate:
12% per year
2/3 due to heart disease
• Revascularisation rate:
18% after 10 years
• Minor amputations:
<10% after 10 years
• Major amputations:
<10% after 10 years
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Lifestyle Modification
Best Medical Treatment
Exercise
I Ila Ilb III IV
Chronic Limb Ischemia Management – General principles
Local Therapy, Amputation
Revascularisation
Prostanoids
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Treatment of Claudication Network of Aims and Options
Survival
Death
Quality of
Life
Walking
Capacity
ABI
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Treatment of Claudication Network of Aims and Options
Supervised
Exercise
Best Medical
Treatment
Revascularisation
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Treatment of Claudication Network of Aims and Options
Supervised
Exercise
Best Medical
Treatment
Revascularisation
Survival
Death
Quality of
Life
Walking
Capacity
ABI
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Treatment of Claudication Network of Aims and Options
Survival
Death
Quality of
Life
Walking
Capacity
ABI
Supervised
Exercise
Revascularisation
Best Medical
Treatment
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Treatment of Claudication Network of Aims and Options
The relative benefits of these 3 strategies of care are not
known because no multicenter clinical trials have directly
compared these 3 strategies.
Study of the comparative effectiveness of claudication
treatment strategies is in the top 50 of all American health
challenges.
Murphy TP et al. Circulation 2012;125:130-9
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Cumulative Relative Risk-Reduction Therapy RRR MACE/10a
40%
Smoking 50% 20%
ASS 25% 15%
Statins 30% 10%
LDL-C 100 70 20% 8%
ACE-I / ARB 25% 6%
ß-Blocker 25% 5%
Lifestyle Modification
Best Medical Treatment
I Ila Ilb III IV
Yus
uf S
Lan
cet
2002
;360
:2-3
.
Fon
arow
GC
et a
l. A
m J
Car
diol
200
0;85
:10A
-17A
.
Modification of Risk
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POSSIBLE BENEFIT CILOSTAZOL
HIGH DOSE STATINS
NAFTIDROFURYL
PENTOXIFYLLINE
PROSTANOIDS
RAMIPRIL
NO BENEFIT HEPARIN / OAC
GINKGO BILOBA
VITAMIN E
OMEGA-3-FA
PADMA 28
GARLIC
Best Medical Treatment Improvement of Walking Distance
Phlebotonics for venous insufficiency (Review)
Martinez-Zapata MJ, Bonfill Cosp X, Moreno RM, VargasE, CapellàD
Thisisareprint of aCochranereview, prepared and maintained byTheCochraneCollaboration and published in TheCochraneLibrary
2008, Issue4
http://www.thecochranelibrary.com
Phlebotonics for venous insufficiency (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John W iley & Sons, Ltd.
JAMA 2013;309:453-60.
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Treatment of Claudication Network of Aims and Options
Supervised
Exercise
Best Medical
Treatment
Revascularisation
Survival
Death
Quality of
Life
Walking
Capacity
ABI
neutral
positive
negative
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Exercise vs. Revascularisation 3 RCTs
MIMIC Trial Mild to Moderate Intermittent Claudication
EJVES 2008;36:680-8.
OMC + SE ± PTA n=127 (93 fem-pop; 34 aorto-iliac); ABI 0.66 – 0.69
1°EP: ICD / AWD
CLEVER Study Claudication: Exercise Vs. Endoluminal
Revascularization
Circulation 2012;125:130-9.
OMC + SE vs. OMC + PTA n=111 (aorto-iliac); ABI 0.66 – 0.73
1°EP: PWT
2°EP: QoL
IRONIC Trial Invasive Revascularization Or Not in IC
Circulation 2014;130:939-47.
OMC + HBE vs. OMC + PTA n=78 (mixed); ABI 0.73 – 0.74
1°EP: PWT
2°EP: QoL
[OMC... Optimal Medical Care, SE...Supervised Exercise; HABE...Home Based Exercise,
ICD...Initial Caldication Distance; AWD...Absolute Walking Distance; PWT ...Peak Walking Time]
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Angioplasty
Intermittent Claudication @ LINC 2015
32 Cases
ABI (median): 0.48
Range: 0.00 - 0.67
IQR: 0.40 - 0.60
Intensity of Claudication:
Severe (RB Category 3)
Absolute (?) walking distance:
50 meters (IQR 20-100)
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Exercise vs. Revascularisation 3 RCTs
MIMIC Trial Mild to Moderate Intermittent Claudication
EJVES 2008;36:680-8.
PTA confers benefit (p<0.05)
CLEVER Study Claudication: Exercise Vs. Endoluminal
Revascularization
Circulation 2012;125:130-9.
SE is superior in PWT (p=0.04)
Improvement in QoL is greater
with PTA (n.s.)
IRONIC Trial Invasive Revascularization Or Not in IC
Circulation 2014;130:939-47.
PTA improves QoL (p<0.01) and
claudication distance (p=0.003)
[OMC... Optimal Medical Care, SE...Supervised Exercise; HABE...Home Based Exercise, ICD...Initial Caldication
Distance; AWD...Absolute Walking Distance; PWT ...Peak Walking Time; QoL Quality of Life]
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PTA vs. OMT (non-randomized)
678 Claudicants ABI ≤0.9; ≥50%Stenosis
6/2007-6/2009
PTA-Group (n=264) ABI: 0.68 ± 0.19
RB-Category 3: 85%*
MWD: 124 ± 306 meters*
OMT-Group (n=215) ABI: 0.66 ± 0.17
RB-Category 3: 37%*
MWD: 403 ± 532 meters* *p<0.001
Giu
glia
no G
et a
l. In
t J C
ardi
ol 2
013;
167;
2566
-71.
PTA
OMT
Effects of lower extremity PTA
on CV outcome in Claudicants
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Effects of lower extremity PTA
on CV outcome in Claudicants PTA vs. OMT (non-randomized)
678 Claudicants ABI ≤0.9; ≥50%Stenosis
6/2007-6/2009
PTA-Group (n=264) ABI: 0.68 ± 0.19
RB-Category 3: 85%*
MWD: 124 ± 306 meters*
OMT-Group (n=215) ABI: 0.66 ± 0.17
RB-Category 3: 37%*
MWD: 403 ± 532 meters* *p<0.001
Giu
glia
no G
et a
l. In
t J C
ardi
ol 2
013;
167;
2566
-71.
PTA OMT
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Survival in Intermittent Claudication
Rutherford RB et al. J Vasc Surg 1997 26:517-38.
Miura T et al. JEVT 2014;21:381-8.
PTA Survival (n=2.930)
97.2% @ 1 yr
90.8% @ 3 yr
83.4% @ 5 yr
Angioplasty Registry Pooled Data
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Treatment of Claudication Network of Aims and Options
Supervised
Exercise
Best Medical
Treatment
Revascularisation
Survival
Death
Quality of
Life
Walking
Capacity
ABI
neutral
positive
negative
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Treatment of Claudication Network of Aims and Options
Supervised
Exercise
Best Medical
Treatment
Revascularisation
Survival
Death
Quality of
Life
Walking
Capacity
ABI
neutral
positive
negative
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Treatment of Claudication Network of Aims and Options
Survival
Death
Quality of
Life
Walking
Capacity
ABI
Supervised
Exercise
Revascularisation
Best Medical
Treatment
neutral
positive
negative
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TASC A TASC B TASC C TASC D
• FAILURE (F)
• COMPLICATION (C)
• RECURRENCE (R)
FCR FCR FCR FCR
Risks of Revascularisation
Patient-Specific Factors
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TASC A TASC B TASC C TASC D
CAREFUL SELECTION AND PREPARATION
• PATIENTS
• TREATING PHYSICIANS
• TREATMENT STRATEGY
FCR FCR FCR FCR
Risks of Revascularisation Risk Reduction
Patient-Specific Factors
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Revascularisation for Claudication?
YES • PAD is cause of
moderate / severe
claudication or
PAD is „subcritical“
• OMT is established
• SE is not available,
feasible or successful
• Risk/Benefit-Ratio is
adaequate
NO • Severe comorbidities
• Intolerance or
non-adherence to
antithrombotic
therapy
René Magritte (1934) La Modèle Rouge
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Revascularisation for Claudication: When is it indicated, when not?
Markus Haumer
Landesklinikum Baden-Mödling
Austria