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Objectives. Peripheral Artery Disease: Review of Diagnosis and Treatment. Vascular Disease in the U.S. PAD Prevalence by Age and Gender

Peripheral Artery Disease: Review of Diagnosis and Treatment Vascular Medicine Columbia University Medical Center 2013 Objectives Overview of epidemiology and risk factors for peripheral artery disease
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Peripheral Artery Disease: Review of Diagnosis and Treatment Vascular Medicine Columbia University Medical Center 2013 Objectives Overview of epidemiology and risk factors for peripheral artery disease (PAD) Non-invasive diagnosis Ankle-brachial index Non-invasive flow studies Medical management and indications for revascularization What Is Peripheral Artery Disease (PAD)? Vascular Disease in the U.S. Definition ranges from broad to specific: Non-coronary : Arterial disease of any etiology in any non-coronary circulation Lower Extremity: Atherosclerotic disease of the aorta and arteries to the lower extremities Prevalence (Millions) Stroke PAD CHD* PAD currently affects 8 12 million Americans, a prevalence second only to CHD. By 2050, the prevalence of PAD is expected to reach 19 million. CHD = coronary heart disease. PAD = peripheral arterial disease. * Includes myocardial infarction and angina pectoris. American Heart Association. Heart Disease and Stroke Statistics 2005 Update Documented Prevalence of PAD PAD Prevalence by Age and Gender NHANES 1 Age 40 San Diego 2 Mean Age=66 NHANES 1 Age 70 Rotterdam 3 Age 55 When common risk factors were included, the prevalence of PAD was approximately 1/3 of patients Diehm 4 Age 65 PARTNERS 5 Age 70, or between with diabetes or smoking 1. Selvin E, Erlinger TP. NHANES. Circulation. 2004;110: Criqui MH et al. Circulation. 1985;71: Meijer WT et al. Arterioscler Thromb Vasc Biol. 1998;18: Diehm C et al. Atherosclerosis. 2004;172: Hirsch AT et al. JAMA. 2001;286: Prevalence of PAD (adults 40 yrs, U.S.) From Selvin E, Erlinger TP. NHANES. Circulation. 2004;110: Risk Factors for PAD in the U.S. Current Smoking 4.46 Diabetes 2.71 GFR 60 ml/min 2.00 Hypertension 1.75 Hyperlipidemia 1.68 Odds ratios for risk factors REACH Overlap in REACH The REACH (REduction of Atherothrombosis for Continued Health) Registry studied 7,013 patients with symptomatic PAD Key Finding 63% of PAD patients had polyvascular* disease CAD 39.4% 14.2% PAD CVD * Age- and gender-adjusted odds ratio. Selvin E. NHANES Circulation. 2004;110: PAD patients with polyvascular disease had concomitant symptomatic cerebrovascular or cardiovascular disease or both. Bhatt DL, et al. American College of Cardiology Scientific Session. March 8, PAD Patients: Increased Risk of Stroke, MI, and Cardiovascular Mortality Increased Risk of CV Mortality x Stroke 1 4x Fatal MI or CHD Death 2 6x Death from CVD 2 Patients with symptomatic PAD face up to 6x greater risk of death from CVD, including MI and stroke A Central Clinical Implication of PAD Any manifestation of PAD should be considered to be a coronary heart disease risk equivalent. 1. Kannel WB. J Cardiovasc Risk. 1994;1: Criqui MH et al. N Engl J Med. 1992;326: Clinical PAD Natural History of PAD: Fate in Five Years The Systemic Disease Am J Cardiol 2001;87(suppl):6D Clinical Symptoms PAD: Diagnosis Physical examination Noninvasive testing Ankle-Brachial Index (ABI) Duplex CTA or MRA Invasive testing Angiogram PAD: Localization Pain just distal to stenosis Aortoiliac: hip/buttocks/thigh pain SFA: calf pain (most common) Range of Symptoms in PAD Patients Asymptomatic: Without obvious symptomatic complaint (but usually with a functional impairment). Classic Intermittent Claudication: Lower extremity symptoms confined to the muscles with a consistent (reproducible) onset with exercise and relief with rest. Atypical leg pain: Lower extremity discomfort that is exertional, but that does not consistently resolve with rest or consistently limit exercise at a reproducible distance PAD: Ischemic Rest Pain Inadequate supply even at rest Worse at night when elevated Relieved with dangling Cool extremity, delayed capillary refill, dependent rubor, & pallor on elevation Critical Limb Ischemia if untreated, is expected to lead to limb amputation within 6 months Critical Limb Ischemia: Rest pain or numbness/tingling, nocturnal pain, pain with elevation, numbness, ulcer Symptomatic PAD PARTNERS Detecting PAD with Symptoms Only 8.7% of patients demonstrated symptoms of classic intermittent claudication (Rose) More than half reported other exertional leg symptoms Percentage of PAD patients who would be MISSED if PCPs looked for only classic symptoms of intermittent claudication Up to 90% Hiatt WR. N Engl J Med. 2001;344. Hirsch AT et al. JAMA. 2001;286: Redefining Asymptomatic? Women s Health and Aging Study N=933; 328 had PAD by ABI 63% reported no leg symptoms ( asymptomatic ) Majority of asymptomatic patients had impaired lower extremity function Slower walking velocity Poorer standing balance score Fewer blocks walked per week After adjustment for traditional risk factors and other comorbidities Pulses DP PT Physical Exam in PAD Femoral Bruit Leg Hair Loss Ulcer in a typical location Dependant Rubor Criqui et al. Circulation 71(3): , 1985 McDermott MM. J Am Geriatr Soc Clinical Symptoms PAD: Diagnosis Physical examination Noninvasive testing Ankle-Brachial Index (ABI) Duplex CTA or MRA Invasive testing Angiogram The Ankle-Brachial Index ABI = The ABI is 95% sensitive and 99% specific for PAD ABI 0.9 establishes the PAD diagnosis Lower extremity systolic pressure Brachial artery systolic pressure Ouriel K. Arch Surg 1982;117: ABI = Ankle-Brachial Index ABI Severity Symptoms 1.4 Calcified Variable Normal No Borderline Variable Mild Claudication Moderate Claudication 0.40 Severe Rest pain PVR Waveforms Exercise NIFS Normal or borderline resting study & high clinical suspicion Particularly useful post-stent Not necessary if normal NIFS with rest pain Treadmill 2 mph, 12% grade, 5 minutes Note symptoms Repeat brachial & ankle exam Drop in pressure Example: 69 y.o. with left calf pain after 2 blocks What next? Exercise Study 5 minutes on treadmill at 10% grade at 1 mph c/o left calf pain after 3 minutes Post-Exercise ABIs 1.01 R and 0.61 L No other tests are necessary. ABI 0.9 means increased cardiovascular morbidity & mortality. Strong Heart Study Association Between Ankle-Brachial Index (ABI) and Mortality Goals of Therapy in PAD All-cause mortality CVD mortality PAD Therapeutic Goals Percent (%) Improve Functional Status and Quality of Life Identify and Treat Systemic Atherosclerosis 10 0 // Preserve the Limb Baseline ABI Adapted from Resnick HE et al. Circulation. 2004;109: Preserving the Limb Attempt to prevent ulcers, infection, & amputation Meticulous foot care essential Treatment of Diabetes Target HbA1C ~ 7% - 7.9% to prevent microvascular complications Smoking cessation Early Revascularization for CLI Goals of Therapy in PAD Improve Functional Status and Quality of Life PAD Therapeutic Goals Identify and Treat Systemic Atherosclerosis Preserve the Limb Changing the Natural History A poor prognosis Even if asymptomatic Very few RCTs; scarce data Subgroup analyses Risk Factor Modification: Smoking Cessation 80% of PAD patients are current or former smokers Risk of death, MI, & amputation is higher with continued smoking Quitting may improve claudication Counseling, NRT, bupropion, & varenicline Risk Factor Modification: Hypertension Target BP 140/90 ( 130/80 DM or CKD) ACE inhibitors, ARBs HOPE Trial (NEJM 2000) 9,297 high-risk patients randomized to ramipril vs placebo; included 4,051 patients with PAD Ramipril reduced risk of stroke, MI, or vascular death by 25% in pts with PAD ONTARGET Trial (NEJM, April 2008) Telmisartan equivalent to ramipril Beta-blockers are NOT contraindicated Risk Factor Modification: Hypertension Target BP 140/90 (JNC 7) Use an ACE inhibitor or ARB if able (not both) Beta-blockers are NOT contraindicated (caution in critical limb ischemia) Statins in PAD Heart Protection Study 20, 536 high risk patients with TC 135 mg/dl Randomized to simvastatin vs placebo 25% risk reduction in vascular events at 5 yrs in PAD subgroup Heart Protection Study Collaborative Group; Lancet, July 2002 Revised NCEP ATP III Guidelines for Lower Extremity PAD PAD = High Risk Very High Risk = PAD and Multiple major risk factors (DM) Poorly controlled risk factors (e.g. current smoking) Multiple risk factors of the metabolic syndrome Target LDL 100 in PAD For very high risk, target LDL 70 is a therapeutic option Statins and Symptoms Scandinavian Simvastatin Survival Study Reduction in new or worsening IC at 3 years 3.6% vs. 2.3%; 38% RRR n=4444 with CAD; Pederson et al, AJC 1998 Simvastatin 40 mg (vs. placebo) improved walking distance, ABI, & post-exercise ABI n=86; Mondillo et al, Am J Med 2003 Atorvastatin 80 mg (vs. 10 mg vs. placebo) improved PFWT n=354; Mohler et al, Circulation 2003 PAD: Antiplatelet Therapy Antithrombotic Trialists Collaboration Meta analysis of 195 trails with 135,640 patients 9,214 patients in the PAD subgroup 23% odds reduction (0.77 RR) in serious vascular events in the antiplatelet treated group (asa, picotamide, ticlopidine, plus others) BMJ 2002;324:71-86 PAD: Antiplatelet therapy POPADAD BMJ Diabetics with ABI 0.99 (asymptomatic) ASA 100mg vs. Placebo No Benefit in ASA for the outcome of MI, stroke or CV death PAD: Antiplatlelet therapy AAA JAMA screened patients, no vascular disease, ABI 0.95 (0.86) ASA 100mg vs. placebo No difference in primary outcome fatal or nonfatal MI or stroke, revascularization Anti-platelet Therapy: Clopidogrel With or without symptoms To prevent MI & stroke No symptomatic benefit Clopidogrel may be marginally better than aspirin but costs $107/month CAPRIE: 19,185 patients with recent MI, stroke, PAD (n=6452) Clopidogrel vs Aspirin Outcome: stroke, MI, vascular death 23% risk reduction in favor of clopidogrel A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE): Lancet 1996 What about aspirin plus clopidogrel? CURE & CREDO - benefit in ACS & PCI MATCH (Management of Atherothrombosis with Clopidogrel in High-risk patients) Clopidogrel alone vs. combination No benefit; increased risk of bleeding Diener et al, Lancet 2004 CHARISMA - no benefit Aspirin alone vs. combination Bhatt et al, NEJM 2006 Antiplatlelet Conclusions 2011 PAD guidelines give antiplatelet therapy a 1A recommendation Aspirin mg and clopidogrel 75 mg are a class 1B New data show aspirin may not be effective in the lower risk groups Do not combine antiplatelet agents or add warfarin for PAD unless there is another indication Diabetes ACCORD NEJM ,251 patients DM2 and vascular disease or multiple risk factors Goal A1c 6.0% vs 7.0 to 7.9 % MI, Stroke or CV Death PAD: Diabetes Goals of Therapy in PAD Improve Functional Status and Quality of Life PAD Therapeutic Goals Identify and Treat Systemic Atherosclerosis Preserve the Limb Medical Management of PAD: Exercise Program 12 week program TIW on a track or treadmill Proven effective Mechanism not known Supervised is superior CPT code since 2001 but not reimbursed Change in Treadmill Walking Distance (%) Effects of Exercise Training on Claudication 0 * Onset of Claudication Pain * Meta-analysis of 21 Studies Maximal Claudication Pain Exercise Training Control * P 0.05 Gardner AW, Poehlman ET. JAMA. 1995;274: Benefits of Exercise Training Meta-analysis 21 studies of claudication patients who underwent exercise training PFWT improved by 180% Maximal walking time improved by 120% Better if 6 months, TIW Gardner et al, Jama 1995 Increases in walking time can exceed those obtained with drug therapies Pharmacologic Options for Claudication Cilostazol (Pletal) Statins? Medical Management of PAD: Cilostazol 1999: FDA approved for IC 5 prospective randomized trials - increased walking distance 40-60% compared with placebo (12-24 wks) Dose: 100 mg BID not with meals Side effects: HA, palpitations, diarrhea Black box warning for CHF patients What is the evidence? Pentoxifylline vs. Cilostazol Effect of Cilostazol on Walking Distance in Patients With Intermittent Claudication No. of Patients Cilostazol 200 mg/d Pentoxifylline 1200 mg/d Cilostazol 200 mg/d Cilostazol 100 mg/d Cilostazol 200 mg/d Cilostazol 200 mg/d % change from baseline of MWD vs. time Cilostazol: significantly different at each point Pentoxifylline: same as placebo Placebo Better Drug Better Reprinted with permission from Hiatt WR. N Engl J Med. 2001;344: Peripheral Intervention: When? Depends on the patient and the practitioner Traditional teaching: Critical limb ischemia Non-healing ulcers, gangrene Lifestyle-limiting claudication not responsive to medical therapy including exercise Reasonable likelihood of symptomatic improvement Favorable risk-benefit ratio (e.g. aortoiliac disease) Threshold is changing Case Illustration 54 y.o. man with claudication History of Present Illness 54 y.o. gentleman presents to PMD Reports bilateral calf pain, right more than left, which begins after 2 blocks; pain possibly also involves thighs Able to walk up to 10 blocks with multiple stops Exercise tolerance is up to 10 blocks limited by calf pain Able to work (has desk job) No pain at rest Past Medical History Current smoker - 2 ppd, 80 pk yr hx Chronic low back pain,?spinal stenosis No prior diagnosis of hypertension, dyslipidemia, or diabetes No history of MI or CAD No prior history of stroke or TIA NKDA, not taking medications currently Physical Examination VS: BP 126/80 B/L, HR 72 Gen: Pleasant, no acute distress Neck: no JVD, no bruits CV: RRR, no m/r/g Lungs: CTA b/l Abd: +bs, soft, no bruits Ext: no edema, no ulcers Pulses: 2+ femoral b/l; 1+ PT/DP Laboratory Studies BUN/CR 12/1.0, electrolytes normal CBC within normal limits Lipids: HDL 30, LDL 168 LFTs within normal limits HbA1C 5.8% Questions to Consider Does this patient have PAD? If so, is it the cause of his symptoms? Why is it important to make the diagnosis? What are the options for this patient in terms of improving his symptoms and his lifestyle? Walks on treadmill at a 12% grade at 1.5 mph Prevention of Cardiovascular Morbidity and Mortality After 2 :33, develops right calf pain After 3:30, develops left calf pain; also reports now that whole right leg is hurting Start aspirin 81 mg daily Start statin to target LDL at least 100, strongly consider target 70 Although normotensive, consider ramipril Smoking cessation! Completes 5 minutes Options for treating this patient's leg symptoms Medical management minimum 3 months Exercise therapy Cilostazol (Pletal) Ongoing risk factor modification Endovascular intervention Ongoing risk factor modification Making the Decision Is there an urgent need for revascularization? No Are the patient's symptoms lifestyle-limiting? Maybe Which arteries are affected and what type of lesions are present? Need further imaging Patient preference Summary of MRA Findings Right: patent iliacs, moderate SFA stenosis, 3v run-off Left: patent iliacs, 4 cm SFA occlusion, 3v runoff Returns 4 months later Decision: Trial of Medical Management Quit smoking! Exercising daily No side effects from cilostazol Taking meds, including ASA and statin LDL 94, BP remains normal Still has mild claudication but can now walk blocks No longer interested in intervention
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