1. PAD Guidelines Changes 2005 >>> 2011 Slides by Omron Healthcare Published online September 29, 2011 http://content.onlinejacc.org/cgi/content/full/j.jacc.2011.08.023

2. Updated summary Category2005 Guidelines2011 Guidelines 1 ABI test - targets -Symptoms - 70 years and older - 50 yrs & older (smoking, DM) -Symptoms -65 years and older - 50 yrs & older (smoking, DM) 2 Cut-off - ABI borderline Not defined Borderline defined as 0.91-0.99 Cut-off - ABI normal 0.91-1.30 1.00-1.40 3 Treatment - Drug PAD patients ABI below 0.9 asymptomatic PAD patients 4 Treatment - Smoking Stop smoking (smoking cessation proguram, drug treatment)

3. 2005 2011 * What is level of evidence? See reference page I IIaIIbIII Must Do Rea sonale Cons ider No Need Change 1 Enlarged Target for Screening PAD screening target  Leg symptoms from exertion  Nonhealing wounds  70 years and older  50 years and older with a history of smoking or diabetes. (Level of Evidence: C ) PAD screening target  Leg symptoms from exertion  Nonhealing wounds  65 years and older  50 years and older with a history of smoking or diabetes (Level of Evidence: B ) Background of the above change On the basis of a large epidemiologic study*, 21% had either asymptomatic or symptomatic PAD. (*The German Epidemiologic Trial on ABI Study Group)

4. Increased value of “Pulsewave” function of VP1000+ for better diagnosis of borderline PAD! The 2005 guidelines are not clearly defined. Borderline is clearly defined ! More patients will be diagnosed as PAD Change 2 >1.40 1.00-1.40 0.91-0.99 <0.90 2005 2011 >1.30 1.00-1.29 0.91-0.99 0.41-0.90 0.00-0.40 Noncompressible Normal Borderline??? PAD (mild-moderate) PAD (Severe) I IIaIIbIII Must Do Rea sonale Cons ider No Need * What is “B”? See reference page Noncompressible Normal Borderline (No change below 0.9) -The upper cut-off has been increased to 1.4, as in TASCII. -ABI borderline is clearly defined as 0.91-0.9

5. Increased importance of Antiplatelet Therapy (esp: Asymptomatic with ABI below 0.9) Change 3 Antiplatelet therapy is indicated to reduce the risk of MI, stroke, or vascular death in PAD patients Antiplatelet therapy is useful to reduce the risk of MI, stroke, and vascular death in asymptomatic patients with an ABI 0.9 or less. Antiplatelet therapy is indicated to reduce the risk of MI, stroke, or vascular death in following patients. -Symptomatic PAD patients with intermittent claudication, ischemia, revascularization, or amputation. The usefulness of antiplatelet therapy in asymptomatic patients with borderline ABI, is not well established. (should be established) More specific 2005 2011 NEW Wider chance for collaboration with antiplatelet pharma companies! Even without symptoms, drug can be prescribed for patients with ABI below 0.9. (See reference page for the pharma list.) NEW

6. Firmer insistence to Stop Smoking (Smoking cessation program, pharmacological treatment) Chance for Omron to collaborate with anti-smoking drug companies! 20052011 Current or former smokers should be advised by clinicians to stop it. And should be offered smoking cessation interventions, including behavior modification therapy, nicotine replacement therapy, or bupropion. 2. Patients should be assisted with counselling & in developing a plan for quitting that includes pharmacotherapy and/or smoking cessation program. 3. Current or former smokers should be advised by clinicians to stop smoking and offered behavioral and pharmacotherapy. 4. (If patients can take drugs), one or more of the following should be offered. New More Specific New -Bupropion (GSK:Zyban) -Varenicline (Pfizer: CHANTIX) -Nicotine replacement therapy (Nicotine patch) *Pharma names and products names are not mentioned in the guidelines but for reference. Change 4 1. Current or former smokers should be asked at every visit about their smoking.

7. Unchanged but important points For all new patients, ABI should be measured in both legs to confirm the diagnosis of lower extremity PAD and establish a baseline. The toe-brachial index should be used to establish PAD diagnosis. Targeted patients are those who are clinically suspected as PAD with “noncompressible” ABI value. (usually long-standing DM or advanced age) ABI should be performed on every PAD suspected patient. Not only specialists, but all clinicians should do ABI! 2-cuff ABI device is not sufficient. ABI should be measured in both legs at the same time! We can actively target the DM market with: “Better PAD diagnosis by adding TBI” 2005 2011 Unchanged Omron promotion Unchanged

8. Dr Alan Hirsch (University of Minnesota, Minneapolis) vice chair of the writing committee chair of the 2005 guidelines He continues to be concerned that cardiovascular practitioners and primary-care physicians —less than full-time PAD-focused vascular surgeons or interventional radiologists— might not recognize critical limb ischemia as a key cardiovascular syndrome that represents a "slow-burning vascular emergency." "For this reason, in every community we lose legs, quality of life, and lives," said Hirsch. Voice from Dr. Hirsch Source: heartwire

9. Standard agreed to only experts [Reference] What is the level of the evidence? Level A Level B Level C Limited population but single study Multiple study

10. [Reference] Antiplatelet pharma DrugProductCompany Acetylsalicylic acidAspirineBayer CilostazolPletaalOtsuka ClopidogrelPravixSanofi Aventis Beraprost NaDornerAstellas Typical/ most prescribed Antiplatelet