Scientific Experts3• 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
Hirsch AT, et al. Circulation 2006; 113(11): e463-654.Mean Prevalence of Intermittent ClaudicationIn Large Population Studies
Natural History of PAD: 5-year OutcomesStableclaudication70%–80%Worseningclaudication10%–20%CLI1%–2%Non-CVD causes25%CVD causes75%Mortality15%–30%Nonfatal CVDevents15%–30%Limb MorbidityLimb morbidity Cardiovascular morbidityand mortality
Intermittent Claudication: ClinicalSignificance• 1% to 5% of people 50 and older haveclaudication symptoms due to PAD.• PAD/claudication is associated with increasedcardiovascular morbidity and mortality.• PAD/claudication is associated withsignificant functional impairment andfunctional decline, compared to peoplewithout PAD.
Treatment Goals in PAD• Reduce cardiovascular event rates.• Improve functional performance and preventmobility loss/functional decline.
Treatment Options for Improving Functioningin 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.9
PAD is well suited for a decision aid• More than one effective treatment optionexists• 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.10
GOALS of PAD Program• To help patients with PAD make informeddecisions about treatment to improve theirwalking ability.• To help PAD patients make informeddecisions about treatment to reduce CVD risk.11
Challenges Encountered in Developing thePAD Program1. Communicating clinically meaningfulimprovements from available therapies topatients is challenging.2. Data on the relative efficacy of availabletreatments are complex.3. Few data exist on adverse outcomes associatedwith revascularization procedures for PAD.4. Supervised treadmill exercise is effective, butnot covered by insurance.16
Challenge #1: How best to communicateimprovement in walking performance?• Most randomized trials in PAD use treadmillwalking distance as the primary outcome.-Translating improvement in treadmill walkinginto improvement in walking in everyday life ischallenging.17
Challenge #1: How best to communicateimprovements in walking performance to PADpatients?• People who did supervised treadmillexercise were able to walk an average of 370feet farther than people who didn’t do awalking program.To help picture 370 feet,think of a football field, which is 300 feet long.18
Challenge #1: How best to communicateimproved walking performance to patients?• The group that took cilostazol could walk anaverage of 140 feet farther than the groupthat didn’t take the medication (140 feet isabout half of a football field.)19
Challenge #2: Data on the relative efficacy ofavailable treatments are complex• How much people improve depends a lot on the sizeand location of the blockages in their arteries.• Could not provide a single estimate of typical improvement inresponse to revascularization.• Measurement of subjective improvement in walkingperformance varies between studies.20
Challenge #3: Few data exist on adverseoutcomes associated with revascularizationprocedures for PAD• There are almost no published data onsurgical revascularization for intermittentclaudication• Solution: We defined adverse outcomes asminor versus major adverse events21
Communicating Risks of Bypass Surgery forClaudication• Surgical revascularization is typically reserved forpatients with severe PAD.• “Most information about serious complications aftersurgery is for people with severe PAD.”• “These people may have more health problems, and sothey could be more likely to have complications thanpeople who have PAD leg pain only when they walk. “22
Resolution of communicating adverse eventsto patients.• Leg angioplasty has fewer seriouscomplications than leg bypass surgery.• About 3 out of 100 people will have a seriouscomplication after leg angioplasty.• Defined primarily as vessel rupture.23
Challenge #4: Supervised treadmill exercise iseffective, but not covered by insurance• Patients lack access to supervised exerciseprograms• Limited (but growing) data supporting home-based programs• How to start your own walking program• Walking logs included24
25Comparing PAD TreatmentsTreatment Benefits Things to ConsiderMedicationsCilostazol •Helps some people walkfarther distances before theyneed to stop because of pain.•Does not relieve pain right away. Youmay need to take pills for 2 to 3months to see if it helps.•May cause side effects, including afast or irregular heartbeat, diarrhea,or headache.•Does not improve walking distancesas much as exercise.Pentoxifylline •Some people feel it helpsthem walk farther distancesbefore they need to stopbecause of pain.•Does not help more than sugar(fake) pills.•May cause side effects, includingstomach bloating, skin flushing,diarrhea, fast or irregular heartbeat,or blurred vision.