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Peripheral Arterial Peripheral Arterial DiseaseDisease
Mehul Bhatt, MDMehul Bhatt, MD
Interventional Cardiology / Vascular Interventional Cardiology / Vascular MedicineMedicine
Athens Heart CenterAthens Heart Center
Two Major Goals in Treating Patients With Two Major Goals in Treating Patients With PADPAD
Improved ability to walkImproved ability to walk
Increase in peak walking Increase in peak walking distancedistance
Improvement in quality-Improvement in quality-of-life (QoL)of-life (QoL)
Prevention of progression to Prevention of progression to critical limb ischemia and critical limb ischemia and amputationamputation
Treatment of critical limb Treatment of critical limb ischemia and amputationischemia and amputation
• Decrease in morbidity Decrease in morbidity from non-fatal MI and from non-fatal MI and strokestroke
• Decrease in Decrease in cardiovascular mortality cardiovascular mortality from fatal MI and strokefrom fatal MI and stroke
Limb outcomes
Cardiovascular morbidity and mortality
outcomes
Medical TreatmentMedical Treatment Smoking cessationSmoking cessation Statin therapyStatin therapy Blood pressure controlBlood pressure control Oral antiplatelet therapyOral antiplatelet therapy Exercise therapyExercise therapy Pentoxifylline / CilostazolPentoxifylline / Cilostazol
Effect of Smoking Cessation on Effect of Smoking Cessation on SurvivalSurvival
0
20
40
60
80
100
0 1 2 3 4 5
Australian censusTobacco abstinenceContinued tobacco use
Years Postoperative
Faulkner KW, et al. Med J Aust. 1983;1:217-219.
133 Patients observed after bypass graft or lumbar sympathectomy
Cum
ula
tive S
urv
ival (%
)
Heart Protection Study:Heart Protection Study:Vascular Event by Prior DiseaseVascular Event by Prior Disease
CBD=cerebrovascular disease; CHD=congestive heart disease. Reprinted with permission from Heart Protection Study Collaborative Group. Lancet. 2002;360:7-22 from Elsevier.
Previous MI23.5
29.4
Other CHD 18.9
24.2No prior CHD or CBV
disease18.7
23.6
Diabetes13.8
18.6
All patients19.8
25.2
1.0 1.2 1.40.80.60.4
24% Reduction (P<.0001)
Existing diseaseStatin Control
Incidence of events
(n=10,269)
(n=10,267) Statin
favoredPlacebo
Risk vs Control
PAD24.7
30.5
Considerations for the Treatment of Considerations for the Treatment of Hypertension in PADHypertension in PAD
Blood pressure lowering is indicated to Blood pressure lowering is indicated to reduce the risk of stroke, MI, CHF, CRF, reduce the risk of stroke, MI, CHF, CRF, and death.and death.
Only major reductions in perfusion Only major reductions in perfusion pressure may worsen claudication (21 pressure may worsen claudication (21 mm Hg decrease in SBP resulted in a 9% mm Hg decrease in SBP resulted in a 9% decrease in absolute claudication decrease in absolute claudication distance).distance).
Individuals with PAD should receive Individuals with PAD should receive hypertension treatment according to hypertension treatment according to current national guidelines (e.g., JNC-7).current national guidelines (e.g., JNC-7).
CRF=chronic renal failure; CHF=congestive heart failure.
- Blockers Are Not - Blockers Are Not Contraindicated in PADContraindicated in PAD
In a meta analysis of 11 randomized In a meta analysis of 11 randomized controlled trials beta-blocker therapy controlled trials beta-blocker therapy did not worsen claudication in did not worsen claudication in patients with PAD.patients with PAD.
Beta blockers had no significant Beta blockers had no significant effect on pain-free walking distance effect on pain-free walking distance compared with placebo in pooled compared with placebo in pooled analysis.analysis.
Radack K. Arch Intern Med. 1991;151:1769.
N=9214.Data from 197 randomized trials comparing an antiplatelet agent (APT; aspirin, clopidogrel,
dipyridamole, or a glycoprotein IIb/IIIa antagonist) vs control or another antiplatelet agent.APT=antiplatelet; CRTL=control.
Antithrombotic Trialists’ Collaboration. BMJ. 2002;324:71-86.
CategoryCategory APTAPT CTRLCTRL Reduction Reduction (%)(%)
Intermittent 6.4% 7.9%Intermittent 6.4% 7.9% 23±9 23±9claudicationclaudication
Peripheral artery 5.4% 6.5% Peripheral artery 5.4% 6.5% 22±16 22±16bypass graftbypass graft
PeripheralPeripheral 2.5% 2.5% 3.6% 3.6%29±3529±35
angioplastyangioplasty
All high-risk patientsAll high-risk patients 22±2 22±2
((PP<.001)<.001)1.00.50.0 1.5 2.0
Antithrombotic Trialists’ Collaboration (ATC):Antithrombotic Trialists’ Collaboration (ATC):
Meta-Analysis of Vascular Events in Antiplatelet Trials in Patients With PADMeta-Analysis of Vascular Events in Antiplatelet Trials in Patients With PAD
Risk Reduction of Clopidogrel vs. Aspirin in Risk Reduction of Clopidogrel vs. Aspirin in Patients With Atherosclerotic Vascular DiseasePatients With Atherosclerotic Vascular Disease
Reprinted with permission from CAPRIE Steering Committee. Lancet. 1996;348:1329-1339.
Stroke
0 10 20-10-20
MI
PAD
All patients
Aspirin favored
-30 30 40
Clopidogrel favored
N=19,185
Intermittent Claudication:Intermittent Claudication:Exercise Therapy (Supervised)Exercise Therapy (Supervised)
FrequencyFrequency:: 3–5 supervised sessions/week 3–5 supervised sessions/week DurationDuration:: 35–50 minutes of 35–50 minutes of
exercise/sessionexercise/session Type of exerciseType of exercise:: treadmill or track walking treadmill or track walking
to near-maximal claudication painto near-maximal claudication pain LengthLength:: 6 months 6 months ResultsResults:: 100%–150% improvement in 100%–150% improvement in
maximal walking distance and associated maximal walking distance and associated improvement in quality-of-lifeimprovement in quality-of-life
Stewart KJ et al. N Eng J Med. 2002;347:1941-1951.
Effects of Exercise Training Effects of Exercise Training on Claudicationon Claudication
Gardner AW, Poehlman ET. JAMA. 1995;274:975-980.
Exercise Training
Control
200
0
20
40
60
80
100
120
140
160
180
Onset of Claudication Pain
Maximal Claudication Pain
Change in T
readm
ill W
alk
ing
Dis
tance
(%
)
Meta-analysis of 21 Studies
*
*
* P < 0.05
Pharmacotherapy for Pharmacotherapy for ClaudicationClaudication
FDA Approved DrugsFDA Approved Drugs: : Pentoxifylline (Trental)Pentoxifylline (Trental)
Cilostazol (Pletal)Cilostazol (Pletal)
Anecdotal Treatments:Anecdotal Treatments: Ranolaxine (Ranexa)Ranolaxine (Ranexa)
Enhanced external counter-pulsation (EECP)Enhanced external counter-pulsation (EECP)
0
10
20
30
40
50
0 4 8 12 16 20 24Treatment (weeks)
Perc
en
tag
e C
han
ge F
rom
B
ase
line M
WD
(m
ean
)
Cilostazol vs. Pentoxifylline: Cilostazol vs. Pentoxifylline: Relative Efficacy to Improve Walking Distance in ClaudicationRelative Efficacy to Improve Walking Distance in Claudication
Cilostazol 100 mg 2 times/day (n=227)Pentoxifylline 400 mg 3 times/day (n=232)Placebo (n=239)
MWD=maximal walking distance. *P<0.001 vs pentoxifylline.
Reprinted from Dawson DL, et al. Am J Med. 2000;109:523-530 with permission from Elsevier.
**
Contraindications to Cilostazol UseContraindications to Cilostazol Use
ProvisosProvisos:: ““CHF of any severity” (systolic dysfunction)CHF of any severity” (systolic dysfunction) Any known or suspected hypersensitivity to any Any known or suspected hypersensitivity to any
of its componentsof its components
Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared with placebo in patients with Class III-IV CHF. PLETAL® is contraindicated in patients with CHF of any severity.
CHF=congestive heart failure.
Pletal® (cilostazol) Package Insert. Rockville, Md: Otsuka America Pharmaceutical, Inc; 1999.