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Slide 1-

A Guidelines-Based Approach to Peripheral Arterial Disease Robert T. Eberhardt, MD Associate Professor of Medicine Boston University School of Medicine Director of Medical Vascular Services Boston Medical Center No disclosures related to presentation
Slide 2-

Evidence-Based Principles to Guide Diagnosis and Treatment 2005 ACC/AHA Guidelines for the Management of Peripheral Arterial Disease 2007 Inter-Societal Consensus for the Management of PAD (TASC II) 2011 ACC/AHA Focused Updated Guidelines for Peripheral Arterial Disease
Slide 3-

Clinical Presentation The Spectrum of Manifestations of PAD Asymptomatic Atypical symptoms Intermittent claudication Critical limb ischemia Rest Pain Ulceration Necrosis/Gangrene Acute limb ischemia
Slide 4-

PAD Case #1 A 74 year old female presents to initiate primary care without complaints She has a history of smoking for 40 years, HTN and “borderline” DM Medications include clonidine Exam reveals BP of 140/86 with non-palpable distal pulses but otherwise no vascular findings Labs with LDL of 138 mg/dl and HgA1C of 8.4
Slide 5-

Why do we care about her diagnosis of PAD?
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Stroke PAD CHD* 0 2 4 6 8 10 12 14 Prevalence (Millions) 16 Prevalence of PAD in the US CHD = coronary heart disease. PAD = peripheral arterial disease. * Includes myocardial infarction and angina pectoris. American Heart Association. Heart Disease and Stroke Statistics—2005 Update. 2005. 5.4 13 8–12
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Prevalence of PAD Increases With Age Adapted from Golomb BA, et al. In: Creager MA, ed. Management of Peripheral Arterial Disease: Medical, Surgical and Interventional Aspects; 2000:1-18. Meijer WT, et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192. Criqui MH, et al. Circulation. 1985;71:510-515. 0 10 20 30 40 50 60 Patients With PAD (%) 55-59 60-64 65-69 70-74 75-79 80-84 85-89 Age Group (years) Rotterdam Study (ABI<0.9, N=7715) San Diego Study (PAD established with noninvasive test, N=613)
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Independent Risk Factors for PAD* Newman AB, et al. Circulation. 1993;88:837-845 * PAD diagnosis based on ABI <0.90. 1.10 1.51 2.55 4.05
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PAD Risk Factors are Synergistic Adapted from TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S1-S296. Kannel WB et al. J Am Geriatr Soc. 1985;33:13-18. Systolic BP 105 150 195 Serum cholesterol 185 260 335 Glucose intolerance 0 0 +
Slide 10-

Prevalence of PAD in At-Risk Patients The PARTNERS* program evaluated 6,979 patients in physicians’ offices. Patient criteria: 70 years, or 50–69 years with a history of smoking and/or diabetes * PARTNERS=PAD Awareness, Risk, and Treatment: New Resources for Survival. Hirsch AT, et al. JAMA. 2001;286:1317-1324. 29% of patients were diagnosed with PAD 29%
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Typical vs Atypical Symptoms in Patients With Symptomatic PAD 33%2 >50%2 1. McDermott MM et al. JAMA. 2001;286:1599-1606. 2. Hiatt WR. N Engl J Med. 2001;344:1608-1621. Other nonspecific leg symptoms that may be indicative of PAD
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Worsening Claudication 16% Natural History Intermittent Claudication Population > 55 yr Intermittent Claudication 5% Peripheral Vascular Outcomes Other Cardiovascular Morbidity/Total Mortality Lower Extremity Bypass Surgery 7% Major Amputation 4% Nonfatal Cardiovascular Event (MI/Stroke) 20% 5-yr Mortality 30% Cardiovascular Cause 75% Weitz JI et al. Circulation. 1996;94:3026–3049.
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*Kaplan-Meier survival curves based on mortality from all causes. †Large-vessel PAD. Adapted from Criqui MH et al. N Engl J Med. 1992;326:381-386. Normal Subjects Asymptomatic LV-PAD† Symptomatic LV-PAD† Severe Symptomatic LV-PAD† 1.00 0.75 0.50 0.25 0.00 0 2 4 6 8 10 12 Survival Year _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Impact of PAD on Mortality
Slide 14-

1. Kannel WB. J Cardiovasc Risk. 1994;1:333-339. 2. Criqui MH et al. N Engl J Med. 1992;326:381-386. Stroke1 Fatal MI or CHD Death2 Death from CVD2 0 2 4 6 8 10 Increased Risk of CV Mortality 4x 2–3x 6x Cardiovascular Events with PAD
Slide 15-

Increased Incidence of Periprocedural Complications in PAD CABG PTCA * P<0.05, †P<0.01. Note all comparisons are PAD vs. no PAD within treatment groups. Rihal C et al. Circulation 1999; 100:171-177. † *
Slide 16-

Prognostic importance of PAD in patients undergoing coronary revascularization 5-year mortality (%) Burek. JACC 1999;34:716-21. (n 336) (n 69) (n 48) (n 21) RR 4.9 (1.8-13.4), p=0.002
Slide 17-

Effect of PVD on Mortality after AMI treated with PCI Guerrero et al. Am J Cardiol 2005;96:649-654.
Slide 18-

What factors may contribute to increase risk in PAD beyond CAD? Impaired endothelial function Heightened inflammation Propensity toward thrombosis Impaired functional capacity with reduced physical activity
Slide 19-

What should we be thinking about in her treatment?
Slide 20-

Treatment of PAD Prevent Ischemic Events Risk factor modification Smoking cessation Goal: complete cessation Lipid management Target LDL < 100 mg/dL Blood pressure control Goal <130/85 mm Hg Blood sugar control Goal: HbA1c <7% Antiplatelet therapies Aspirin or Clopidogrel Goal: reduction in risk of MI, stroke, and vascular death Only clopidogrel is FDA approved Many professional societies include ASA among first line agents in guidelines
Slide 21-

Effect of Smoking Cessation on Survival in PAD 131 Patients Followed After Bypass Graft or Lumbar Sympathectomy Surgery Faulkner et al. Med J Aust 1983;1:217.
Slide 22-

Impact of Smoking Cessation on PAD Jonason & Bergström. Acta Med Scand 1987;221:253-60
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Cholesterol Reduction and the Development of Intermittent Claudication Scandinavian Simvastatin Survival Study Pedersen et al. Am J Card 1998;81:333-5. Placebo 38% Simvastatin ]
Slide 24-

Heart Protection Study: Vascular Event by Prior Disease Heart Protection Study Collaborative Group. Lancet. 2002;360:7-22. MI - myocardial infarction; CHD - coronary heart disease; CVD - cerebrovascular disease; PAD - peripheral arterial disease; CI - confidence interval; SE - standard error Previous MI 23.5 29.4 Other CHD 18.9 24.2 No prior CHD or CVD 18.7 23.6 Peripheral arterial disease 24.7 30.5 Diabetes 13.8 18.6 All patients 19.8 25.2 1.0 1.2 1.4 0.8 0.6 0.4 24% Reduction (p<0.0001) Existing Disease Statin Control Incidence of Events (n=10,269) (n=10,267) Statin Favored Placebo Risk versus Control
Slide 25-

ACE Inhibition and Cardiovascular Events in High-Risk Patients The Heart Outcome Prevention Evaluation Study. NEJM 2000;342:145-53.
Slide 26-

Effect of ACE Inhibition on Cardiovascular Events in PAD Overall 9297 PAD 4051 No PAD 5246 The Heart Outcome Prevention Evaluation Study. NEJM 2000;342:145-53. Major Adverse Cardiac Events Relative Risk in Ramipril Group (95% confidence interval) 0.6 0.8 1.0 1.2 No. of Patients
Slide 27-

ACC/AHA 2005 Guidelines Risk Factor Management in PAD Lipid-lowering drugs Antihypertensive drugs All patients with PAD: Statin treatment to achieve LDL level <100 mg/dL Patients with very high risk of ischemic events: Consider LDL of <70 mg/dL Target blood pressure <140/90 mm Hg to reduce cardiovascular risk If comorbid diabetes or chronic renal disease, target blood pressure <130/80 mm Hg
Slide 28-

Recommendations for Smoking Cessation Patients who are smokers or former smokers should be asked about status of tobacco use at every visit. Patients should be assisted with counseling and developing a plan for quitting that may include pharmacotherapy and/or referral to a smoking cessation program. Individuals with lower extremity PAD who smoke cigarettes or use other forms of tobacco should be advised by each of their clinicians to stop smoking and offered behavioral and pharmacological treatment. In the absence of contraindication or other compelling clinical indication, 1 or more of the following pharmacological therapies should be offered: varenicline, bupropion, and nicotine replacement therapy. NEW NEW MODIFIED NEW
Slide 29-

Effect of Antiplatelet Therapy on Cardiovascular Events in PAD 42 clinical trials 9,214 patients with PAD 23% reduction in serious adverse vascular events (P=0.004) Benefits similar among PAD subtypes (intermittent claudication, peripheral grafting, and peripheral angioplasty) Antithrombotic Trialists’ Collaboration. BMJ. 2002;324:71-86.
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Effect of Aspirin vs Other Antiplatelet Agents in Reducing Vascular Events in Patients with PAD* 0 2 4 6 8 10 12 Aspirin Other antiplatelet agents* Derived from Robless P et al. Br J Surg. 2001;88:787-800. Patients (%) with event P=0.003 *Meta-analysis. Other antiplatelet agents included ticlopidine, clopidogrel, or dipyridamole/aspirin combination. Treatment with other antiplatelet therapy resulted in a 24% reduction in vascular events compared with aspirin alone
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Months of Follow-Up Cumulative Event Rate (%) 0 4 8 12 16 Clopidogrel Aspirin Overall Relative Risk Reduction 8.7%* 0 3 6 9 12 15 18 21 24 27 30 33 36 Aspirin 5.83% 5.32% Clopidogrel Event Rate per Year P = 0.045 *ITT analysis. CAPRIE Steering Committee. Lancet 1996;348:1329-1339. Clopidogrel vs. Aspirin in Prevention of Ischemic Events
Slide 32-

Risk Reduction of Clopidogrel vs. Aspirin -10 -5 0 5 10 15 20 25 30 Stroke MI PAD All Patients % Risk Reduction CAPRIE Steering Committee. Lancet.1996;348:1329-1339. Reduction in Combined Primary End Point (ischemic stroke, MI, or vascular death)
Slide 33-

Effect of Dual Antiplatelet Therapy with High Risk Atherosclerotic Disease Bhatt, D. et al. N Engl J Med 2006;354:1706-1717
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Safety and Efficacy of Dual Antiplatelet Therapy with High Risk Atherosclerotic Disease Bhatt, D. et al. N Engl J Med 2006;354:1706-1717
Slide 35-

Bhatt, D. L. et al. J Am Coll Cardiol 2007;49:1982-1988 Effect of Dual Antiplatelet Therapy with Established Atherosclerotic Disease
Slide 36-

Bhatt, D. L. et al. J Am Coll Cardiol 2007;49:1982-1988 Effect of Dual Antiplatelet Therapy with Established Atherosclerotic Disease
Slide 37-

Effect of Aspirin on the Prevention of Cardiovascular Events in PAD Berger, J. S. et al. JAMA 2009;301:1909-1919
Slide 38-

Aspirin for Prevention Cardiovascular Events with Low ABI Fowkes, F. G. R. et al. JAMA 2010;303:841-848
Slide 39-

Recommendations for Antiplatelet and Antithrombotic Drugs Antiplatelet therapy is indicated to reduce the risk of MI, stroke, and vascular death in symptomatic PAD Aspirin, 75 to 325 mg, is recommended as safe and effective antiplatelet therapy. Clopidogrel (75 mg per day) is recommended as a safe and effective alternative antiplatelet therapy to aspirin MODIFIED MODIFIED MODIFIED
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Recommendations for Antiplatelet and Antithrombotic Drugs NEW NEW NEW Antiplatelet therapy can be useful to reduce the risk of MI, stroke, or vascular death in asymptomatic individuals with an ABI ≤0.90. The usefulness of antiplatelet therapy to reduce the risk of MI, stroke, or vascular death in asymptomatic individuals with borderline abnormal ABI, defined as 0.91 to 0.99, is not well established. The combination of aspirin and clopidogrel may be considered to reduce the risk of cardiovascular events in symptomatic PAD, not at increased risk of bleeding and at high perceived cardiovascular risk
Slide 41-

Risk Reduction with ACE-inhibitors, Statins, and Antiplatelet Therapy in PAD APTC Antiplatelet Trialists’ Collaboration. BMJ. 1994;308:81-106. CAPRIE Steering Committee. Lancet. 1996;348:1329-1339. HOPE Study Investigators. N Engl J Med. 2000;342:145-153. Heart Protection Study Collaborative Group. Lancet. 2002;360:7-22. placebo 6.0% CAPRIE* clopidogrel 4.9% 3.7% 0 1 2 3 4 5 6 7 HOPE* ramipril 4.4% 3.4% placebo HPS* placebo simvastatin 6.1% 4.9% aspirin Event Rate (% per year) APTC* No. of Patients (>9000) (>6000) (4051) (2701) P < 0.001 P < 0.001 *PAD subgroups only.
Slide 42-

PAD Case #2 A 58 year old male presents with exertional left calf discomfort at ½ block Symptoms occur reproducibly with exertion and relieved by rest He has a history of DM, HTN, tobacco use, and known PAD with prior left femoral-popliteal bypass surgery Medications include lisinopril, metoprolol, atorvastatin, aspirin 81mg, and metformin. Exam reveals palpable femoral pulses without bruits, diminished popliteal and distal pulse on left, and no positional color changes or skin breakdown
Slide 43-

How do we establish a diagnosis of PAD or assess severity and localize disease?
Slide 44-

Ischemia in Buttock, hip, thigh Thigh, calf Calf, ankle, foot Obstruction in Aorta or iliac artery Femoral artery or branches Popliteal artery or distal Common Sites of Claudication
Slide 45-

Effect of Claudication on Peak Oxygen Consumption Hiatt WR. J Appl Physiol. 1992;73:346-53. Hiatt WR. Circulation. 1990;81:602-9. Normal IC Peak VO2 30–40 15–20 mL/kg/min mL/kg/min* *Approximates peak oxygen uptake of patients with NYHA class III CHF.
Slide 46-

Does the Patient Have Intermittent Claudication?
Slide 47-

Diagnostic Testing Ankle-brachial index Segmental limb pressures Pulse volume recordings Doppler velocity waveform analysis Functional testing Treadmill exercise testing Duplex scanning Advanced imaging techniques
Slide 48-

How to Perform and Calculate the ABI ≥1.0 — Normal 0.81-0.90 — Mild Obstruction 0.41-0.80 — Moderate Obstruction ≤0.40 — Severe Obstruction Right Arm Pressure: Left Arm Pressure: Pressure: PT DP Right ABI Higher Right Ankle Pressure mm Hg Higher Arm Pressure mm Hg = = Left ABI Higher Left Ankle Pressure mm Hg Higher Arm Pressure mm Hg Pressure: PT DP
Slide 49-

Segmental Limb Pressure and Pulse Volume Recordings 170 158 154 152 1.0 140 116 100 98 0.64 ABI 150 150 Brachial
Slide 50-

ACC/AHA 2005/2011 Guidelines Diagnosis of PAD Use resting ankle brachial index (ABI) to establish lower extremity PAD diagnosis in those with suspected PAD, defined as individuals with 1 or more of the following: exertional leg symptoms, nonhealing wounds, age ≥65 years, or ≥50 years with a history of smoking or diabetes. Use ABI to confirm and diagnosis and establish a baseline in all new patients with PAD, regardless of severity Use toe-brachial index to establish a diagnosis of PAD in those with non-compressible vessels Segmental pressure measurements are useful to when anatomic localization of PAD is required to create a therapeutic plan MODIFIED
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History and Physical Exam Resting ABI Normal or Indeterminant Abnormal (<0.90) Treadmill Testing Non-Invasive Testing Pulse Volume Recording Doppler Waveform Analysis Duplex Imaging Normal Abnormal Evaluate Other Etiologies Diagnosis Confirmed Assess Severity Initiate Therapy Normal Establishing the Diagnosis of Intermittent Claudication
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Post Exercise Ankle Pressures
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Advanced Vascular Imaging CT Angiography Maximum-intensity projection (MIPs) Angiographic like representation Volume rendering Preserves depth information Multi-planar reformat Curved planar reformat (CPR) Perpendicular to median arterial centerline MR Angiography Traditional: Time of flights Contrast-enhanced MRA Improves speed of exam, anatomic coverage, and small- vessel resolution Time-resolved gadolinium enhanced sequences Time-resolved imaging of contrast kinetics (TRICKS) Provides angiographic like dynamic contrast passage Moving-table technique or multi-array, parallel-imaging Optimize large field-of-view imaging
Slide 54-

He is sent for ABI/PVR and arterial duplex revealing ABI 0.5 on left with femoral-popliteal involvement and an occluded bypass graft What treatments should we offer to those with intermittent claudication?
Slide 55-

Treatment of PAD Therapies Based Upon Symptoms Intermittent Claudication Exercise Therapy Drugs Pentoxifylline Cilostazol Revascularization Severe disability Goal to provide relief of symptoms Critical limb ischemia Wound care Antibiotics Revascularization Endovascular Surgery Goal to promote limb survival
Slide 56-

Treatment of PAD Effect of Drug Therapy on Walking Distance Hiatt WR. N Engl J Med. 2001; 344;1608-1621. Meta-analysis of 4 randomized, placebo-controlled trials Pentoxifylline, 1200 mg/day 698 Cilostazol, 200 mg/day Cilostazol, 200 mg/day 516 Compound, dose N Cilostazol, 100 mg/day Cilostazol, 200 mg/day 239 1.0 1.4 1.6 0.8 0.6 Cilostazol, 200 mg/day 81 1.8 Placebo 1.2 Relative Increase in Maximum Walking Distance (ratio of change in exercise performance versus placebo) Treatment Favored
Slide 57-

Maximal Walking Distance Before and After Drug Withdrawal Double-blind therapy Single-blind placebo Dawson et al. Am J Surg. 1999;178:141-6.
Slide 58-

Most Common Adverse Event Percent Reporting Adverse Event Dawson et al. Am J Med. 2000.
Slide 59-

Effect of Atorvastatin of Maximum Walking Time in PAD Mohler E R et al. Circulation 2003;108:1481-1486
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Effect of Atorvastatin of Pain-Free Walking Time in PAD Mohler E R et al. Circulation 2003;108:1481-1486
Slide 61-

Effects of ACE inhibition on Claudication Ahimastos AA, et al. JAMA 2013;309:453-60.
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Ahimastos AA, et al. JAMA 2013;309:453-60. Additional Effects of ACE Inhibition in PAD
Slide 63-

Exercise for PAD? Your legs hurt when you walk so go out and walk?
Slide 64-

Effect of Exercise Training on Walking Ability in PAD % Improvement Pain-Free Peak Treadmill Walking Time Controlled trials Uncontrolled trials 96 % 134 % Gardner AW. JAMA. 1995;274:975-980.
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Treatment of PAD Effect of Exercise Training Gardner AW. 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 Treadmill Walking Distance (%) Meta-analysis of 21 Studies
Slide 66-

Treatment of PAD Effect of Exercise Components on Walking Distance < 30 min/session  30 min/session < 3 session/wk  3 sessions/wk < 26 weeks  26 weeks Onset of Pain Near-Maximal Pain Walking Combination 144  419 653  364 * 249  350 541  263 * 275  228 519  409 * 196  78 607  427 * 512  483 * 287  127 Exercise Duration Exercise Frequency Length of Program Training End Point Mode of Exercise Gardner. JAMA 1995;274:975-980. * P < 0.05
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ACC/AHA 2005 Guidelines Treatment of Claudication Exercise Drug therapy Supervised exercise training should be the initial treatment 30-45 minute sessions 3 or more times per week At least 12 weeks Value of unsupervised exercise programs is not well established Cilostazol 100 mg twice daily Can improve symptoms & increase walking distance Indicated for lifestyle-limiting claudication Contraindicated in patients with heart failure Pentoxifylline 400 mg three daily Consider as an alternative to cilostazol Effectiveness of pentoxifylline is marginal and not well established
Slide 68-

Revascularization for Aorto-Iliac Arterial Disease Aortofemoral Bypass Primary patency at 5 years of 81-85%1 Perioperative mortality 5-8%1 Reserved for severe diffuse disease cases2 Indicated for Rutherford class  32 1. Raptis S. et al. Eur. J. Vasc. Endovasc. Sur. 1995; 9: 97-102 2. Rosenfield K and Isner JM. Chap 97 in Textbook of Cardiovascular Medicine 1998 Percutaneous Intervention Patency at 5 years of 65-80%1 Perioperative mortality 0.1%1 Treatment of choice3 Indicated for Rutherford class  22 1. Becker GJ et al. Radiology 1989;170:921-940 2. Belli A-M et al. Clin Radiol 1990;41:380-3 3. Rosenfield K and Isner JM. Chap97 in Textbook of Cardiovascular Medicine 1998
Slide 69-

Lesion-guided approach for treatment of aorto-iliac disease TASC II 2007: Europ J Vasc Endovasc Surg 2007:33(S1):S52 A Endovascular is procedure of choice B Endovascular is preferred therapy C Surgery is preferred for good-risk D Surgery is procedure of choice
Slide 70-

Treatment of PAD Revascularization for Femoro-Popliteal Disease Femoro-Popliteal Bypass Surgery Primary patency at 5 years of 60-80% Autologous veins preferred to synthetic grafts Perioperative mortality 0-3% Indicated for Rutherford class  3 Femoro-Popliteal Angioplasty Patency at 2-5 years ranges between 40-70% Technical problems due several anatomic issues: Occlusions vs stenosis Diffuse disease Adductor canal Disease in run off vessels Perioperative mortality is very low Indicated for Rutherford class  2
Slide 71-

Lesion-guided approach for treatment of femoro-popliteal disease TASC II 2007: Europ J Vasc Endovasc Surg 2007:33(S1):S58 A Endovascular is procedure of choice D Surgery is procedure of choice B Endovascular is preferred therapy C Surgery is preferred for good-risk
Slide 72-

ACC/AHA 2005 Guidelines Treatment of Claudication Endovascular therapies Surgery Only indicated for patients with Vocational or lifestyle-limiting disability; Reasonable likelihood of symptomatic improvement; Prior failure of exercise or pharmacological therapy; and, Favorable risk-benefit ratio Not indicated as a prophylactic treatment Preferred method for revascularization of TASC type A iliac and femoropopliteal arterial lesions Indicated for patients With significant functional disability from symptoms Who are unresponsive to exercise or pharmacotherapy Who have a reasonable likelihood of symptomatic improvement Surgical intervention is not indicated to prevent progression to limb-threatening ischemia
Slide 73-

Exercise vs Stenting for Claudication CLEVER: Circulation. 2012;125:130-139
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Exercise vs Stenting for Claudication CLEVER: Circulation. 2012;125:130-139
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Exercise vs Stenting for Claudication CLEVER: Circulation. 2012;125:130-139 _
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Exercise vs Stenting for Claudication CLEVER: Circulation. 2012;125:130-139 -
Slide 77-

He is placed on cilostazol 100 mg twice daily and advised to perform interval exercise training but claudication remains at 1 block. So what if initial treatment is inadequate?
Slide 78-

Rogers, J. H. et al. Circulation 2007;116:2072-2085 Overview of New Technologies
Slide 79-

Angioplasty vs. Stent in the Superficial Femoral Artery Schillinger, M. et al. N Engl J Med 2006;354:1879-1888
Slide 80-

Primary Patency Femoral Angioplasty vs Stenting Laird et al. Circ Cardiovasc Interv 2010;3:267-276
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Clinical Effects of Primary Stenting vs Angioplasty for Femoral Dz Schillinger et al. N Engl J Med 2006;354:1879-1888.
Slide 82-

Paclitaxel Coated Balloon for Femoropopliteal Dz Tepe et al. NEJM 2008;358:689-99. P<0.001 P<0.001
Slide 83-

DES vs Angioplasty for Femoropopliteal Dz Zilver (Paclitaxel) Stent Dake M D et al. Circ Cardiovasc Interv 2011;4:495-504
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DES vs Angioplasty for Femoropopliteal Dz Zilver (Paclitaxel) Stent Dake M D et al. Circ Cardiovasc Interv 2011;4:495-504
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He has resolution of his left leg claudication. ABI improved from 0.5 to 0.75. He is now >3 year post intervention and without claudication or cardiac events.
Slide 89-

Assess severity of claudication Treatment Approach to Intermittent Claudication Mild to moderate claudication Exercise & drug therapy Symptoms debilitating Symptoms improve Localize lesion Consider percutaneous intervention Severe claudication Popliteal-tibial dz Continue present therapy Aortoiliac or femoral dz Exercise & drug therapy unless debilitating
Slide 90-

PAD Case #3 A 66 year old male presents with intense rest discomfort of his left foot He was previously seen with claudication of both legs and placed on Pletal He has a history of HIV with peripheral neuropathy, dyslipidemia and tobacco use. Medications include pravastatin, Lopinivir/Rotinivir, Abacavir, Lamivudine, Notriptyline, Gabapentin Exam reveals non-palpable pulses in left leg with pallor upon elevation and dependent rubor Labs with ABI 0.5 on left and 0.9 on right
Slide 91-

Lower Extremity Segmental Pressures Right Index Left Index Brachial 122 mmHg 123 mmHg Thigh 127 mmHg 1.03 66 mmHg 0.54 Calf 115 mmHg 0.93 64 mmHg 0.52 Ankle/PT 108 mmHg 0.88 63 mmHg 0.51 Ankle/DP 114 mmHg 0.93 57 mmHg 0.46 Lower Extremity Pulse Volume Recording Right Amplitude Left Amplitude Thigh Normal 16 Moderate 11 Calf Mild 17 Moderate 11 Ankle Normal 18 Moderate 9 Metatarsal Normal 15 Severe
Slide 92-

What should be done in his management?
Slide 93-

Alive with 2 Limbs 45% Natural History of Critical Limb Ischemia Critical Limb Ischemia (Rest Pain, Ulceration or Gangrene) 1-3% 1-Year Outcomes Mortality 25% Amputation 30% Hirsh et al. JACC. 2006;47:1239-1312. Continued CLI 20% CLI Resolved 25%
Slide 94-

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial Compared angioplasty first with surgery first for critical limb ischemia - 195/228 (86%) bypass surgery and 216/224 (96%) balloon angioplasty Compared with angioplasty, surgery was associated with lower immediate failure (3% versus 20%) higher 30-day morbidity (57% versus 41%) lower 12-month reintervention (18% versus 26%)
Slide 95-

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial Bradbury AJ, et al. J Vasc Surg 2010;51:5S-17S Overall Survival Amputation Free Survival
Slide 96-

Cox proportional hazards analysis for surgery first by time from randomization < 2 years and > 2 years End point Time Estimate 95% CI P-value Amputation-free survival Unadjusted Before 2 years 1.05 (0.78 to 1.41) 0.76 After 2 years 0.80 (0.55 to 1.16) 0.24 Adjusted Before 2 years 1.03 (0.76 to 1.39) 0.85 After 2 years 0.85 (0.50 to 1.07) 0.11 Overall survival Unadjusted Before 2 years 1.17 (0.83 to 1.65) 0.36 After 2 years 0.62 (0.43 to 0.90) 0.01 Adjusted Before 2 years 1.19 (0.84 to 1.68) 0.32 After 2 years 0.61 (0.50 to 0.75) 0.009 * Adjusted for stratification, creatinine, body mass index, diabetes, age, smoking, statin at baseline and below-knee Bollinger angiogram score. Bradbury et al. Journal of Vascular Surgery 2010:;51: 5S-17S.
Slide 97-

Recommendations for CLI: Endovascular and Open Surgical Treatment for Limb Salvage For patients with limb-threatening lower extremity ischemia and an estimated life expectancy of <2 years or in patients in whom an autogenous vein conduit is not available, balloon angioplasty is reasonable to perform when possible as the initial procedure to improve distal blood flow. For patients with limb-threatening ischemia and an estimated life expectancy of >2 years, bypass surgery, when possible and when an autogenous vein conduit is available, is reasonable to perform as the initial treatment to improve distal blood flow. NEW NEW
Slide 98-

General Principle for Revascularization Claudicants should be revascularized only after a trial of exercise and pharmacotherapy. An exception may be isolated iliac artery stenosis. Inflow and outflow should always be assessed prior to revascularization. Inflow lesions should be revascularized first followed by outflow lesions if bothersome symptoms persist. Revascularization for critical limb ischemia with associated tissue loss should aim to provide straight line flow to the foot.
Slide 99-

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The patient underwent angiography revealing a 70% R iliac artery stenosis and a long occlusion of the L iliac arteries Attempt to cross L iliac lesion was unsuccessful He underwent R iliac artery stent placement followed by a R to L femoral to femoral artery bypass graft Resolution of his rest ischemia to his left foot
Slide 101-

Use of Coronary Revascularization Prior to Vascular Surgery McFalls EO, et al. NEJM 2004:351:2795.
Slide 102-

Use of Beta-Blockade during Vascular Surgery Poldermans D et al. NEJM 2004;341:1789.
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Use of Statin Therapy during Vascular Surgery Durazzo AES et al. J Vasc Surg 2004;39:967.
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Summary of PAD and Its Management PAD is common and has a significant impact upon cardiovascular outcomes Treatment of PAD, even asymptomatic, should focus on risk factor modification/risk reduction Treatment of intermittent claudication should include exercise therapy, drug therapy and selective use of revascularization Treatment for critical limb ischemia warrants aggressive efforts at revascularization, including surgery, to reduce the risk of amputation