This document summarizes a medical editors meeting about treatment options for peripheral artery disease (PAD). It discusses the development of an educational program about PAD for patients. The program aims to help patients make informed decisions about improving walking ability and reducing cardiovascular risk. Challenges in developing the program included communicating treatment benefits, comparing varied efficacy data, and addressing uninsurance coverage for supervised exercise. The document outlines strategies for addressing these challenges.

1. M e d i c a l E d i t o r s M e e t i n g – J a n u a r y 2 9 , 20 13
Treatment Choices for Peripheral
Artery Disease
Suzanne Brodney and Mary McGrae McDermott
January 2013

2. Program Development
• Focus groups
• Patient interviews
• Physicians
• Writer/producer
• Clinical reviewers
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3. Scientific Experts
3
• Dr. Mary McDermott- Northwestern University
• Dr. Michael Conte – University of California, SF
• Dr. Mark Creager – Brigham andWomen’s Hospital
• Dr. Curt Diehm – University of Heidelberg
• Dr. Gerry Fowkes – University of Edinburgh
• Dr. Heather Gornik – Cleveland Clinic
• Dr.William Hiatt – Colorado Prevention Center
• Dr. Melina Kibbe – Northwestern University
• Dr. Lars Norgren – University Hospital, Sweden

4. Hirsch AT, et al. Circulation 2006; 113(11): e463-654.
Mean Prevalence of Intermittent Claudication
In Large Population Studies

5. PAD Risk Factors
• Older age
• Diabetes mellitus
• Smoking
• Hypertension
• Hyperlipidemia
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6. Natural History of PAD: 5-year Outcomes
Stable
claudication
70%–80%
Worsening
claudication
10%–20%
CLI
1%–2%
Non-CVD causes
25%
CVD causes
75%
Mortality
15%–30%
Nonfatal CVD
events
15%–30%
Limb MorbidityLimb morbidity Cardiovascular morbidity
and mortality

7. Intermittent Claudication: Clinical
Significance
• 1% to 5% of people 50 and older have
claudication symptoms due to PAD.
• PAD/claudication is associated with increased
cardiovascular morbidity and mortality.
• PAD/claudication is associated with
significant functional impairment and
functional decline, compared to people
without PAD.

8. Treatment Goals in PAD
• Reduce cardiovascular event rates.
• Improve functional performance and prevent
mobility loss/functional decline.

9. Treatment Options for Improving Functioning
in PAD
• Medications
• Two FDA-approved medications
• Cilostazol
• Pentoxifylline
• Supervised treadmill exercise
• Not covered by medical insurance.
• Lower extremity revascularization.
• Lower extremity angioplasty/stenting.
• Surgical revascularization.
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10. PAD is well suited for a decision aid
• More than one effective treatment option
exists
• Both exercise and revascularization are effective.
• Very different types of interventions.
• No clear evidence that one is superior.
• Practice variation exists.
• Interventionalists like to intervene.
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11. GOALS of PAD Program
• To help patients with PAD make informed
decisions about treatment to improve their
walking ability.
• To help PAD patients make informed
decisions about treatment to reduce CVD risk.
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13. 13

14. 14

15. 15

16. Challenges Encountered in Developing the
PAD Program
1. Communicating clinically meaningful
improvements from available therapies to
patients is challenging.
2. Data on the relative efficacy of available
treatments are complex.
3. Few data exist on adverse outcomes associated
with revascularization procedures for PAD.
4. Supervised treadmill exercise is effective, but
not covered by insurance.
16

17. Challenge #1: How best to communicate
improvement in walking performance?
• Most randomized trials in PAD use treadmill
walking distance as the primary outcome.
-Translating improvement in treadmill walking
into improvement in walking in everyday life is
challenging.
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18. Challenge #1: How best to communicate
improvements in walking performance to PAD
patients?
• People who did supervised treadmill
exercise were able to walk an average of 370
feet farther than people who didn’t do a
walking program.To help picture 370 feet,
think of a football field, which is 300 feet long.
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19. Challenge #1: How best to communicate
improved walking performance to patients?
• The group that took cilostazol could walk an
average of 140 feet farther than the group
that didn’t take the medication (140 feet is
about half of a football field.)
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20. Challenge #2: Data on the relative efficacy of
available treatments are complex
• How much people improve depends a lot on the size
and location of the blockages in their arteries.
• Could not provide a single estimate of typical improvement in
response to revascularization.
• Measurement of subjective improvement in walking
performance varies between studies.
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21. Challenge #3: Few data exist on adverse
outcomes associated with revascularization
procedures for PAD
• There are almost no published data on
surgical revascularization for intermittent
claudication
• Solution: We defined adverse outcomes as
minor versus major adverse events
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22. Communicating Risks of Bypass Surgery for
Claudication
• Surgical revascularization is typically reserved for
patients with severe PAD.
• “Most information about serious complications after
surgery is for people with severe PAD.”
• “These people may have more health problems, and so
they could be more likely to have complications than
people who have PAD leg pain only when they walk. “
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23. Resolution of communicating adverse events
to patients.
• Leg angioplasty has fewer serious
complications than leg bypass surgery.
• About 3 out of 100 people will have a serious
complication after leg angioplasty.
• Defined primarily as vessel rupture.
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24. Challenge #4: Supervised treadmill exercise is
effective, but not covered by insurance
• Patients lack access to supervised exercise
programs
• Limited (but growing) data supporting home-
based programs
• How to start your own walking program
• Walking logs included
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25. 25
Comparing PAD Treatments
Treatment Benefits Things to Consider
Medications
Cilostazol •Helps some people walk
farther distances before they
need to stop because of pain.
•Does not relieve pain right away. You
may need to take pills for 2 to 3
months to see if it helps.
•May cause side effects, including a
fast or irregular heartbeat, diarrhea,
or headache.
•Does not improve walking distances
as much as exercise.
Pentoxifylline •Some people feel it helps
them walk farther distances
before they need to stop
because of pain.
•Does not help more than sugar
(fake) pills.
•May cause side effects, including
stomach bloating, skin flushing,
diarrhea, fast or irregular heartbeat,
or blurred vision.