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Peripheral Arterial Disease: missed opportunity for cardiovascular intervention

NIC Kolkata 2013. Peripheral Arterial Disease: missed opportunity for cardiovascular intervention. Subhash Banerjee, MD Chief, Division of Cardiology VA North Texas Healthcare System Associate Prof. in Medicine UT Southwestern Med. Ctr. Oct. 2013. Worldwide PAD Trends ( 2013).

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Peripheral Arterial Disease: missed opportunity for cardiovascular intervention

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  1. NIC Kolkata 2013 Peripheral Arterial Disease: missed opportunity for cardiovascular intervention Subhash Banerjee, MD Chief, Division of Cardiology VA North Texas Healthcare System Associate Prof. in Medicine UT Southwestern Med. Ctr. Oct. 2013

  2. Worldwide PAD Trends (2013) 54·8 million in southeast Asia Fowkes et al. Lancet 2013

  3. 0% 5% 10% 15% 20% 25% 30% 35% Prevalence of PAD In a primary care population defined by age and common risk factors, the prevalence of PAD was approximately one in three patients NHANES1 Aged >40 years 4.3% San Diego2 Mean age 66 years 11.7% NHANES1 Aged 70 years 14.5% Rotterdam3 Aged >55 years 19.1% Diehm4 Aged 65 years 19.8% PARTNERS5 Aged >70 years, or 50–69 years with a history diabetes or smoking 29% NHANES=National Health and Nutrition Examination Study; PARTNERS=PAD Awareness, Risk, and Treatment: New Resources for Survival [program]. 1. Selvin E, Erlinger TP. Circulation. 2004;110:738-743.2. Criqui MH, et al. Circulation. 1985;71:510-515.3. Diehm C, et al. Atherosclerosis. 2004;172:95-105. 4. Meijer WT, et al. ArteriosclerThrombVasc Biol. 1998;18:185-192. 5. Hirsch AT, et al. JAMA. 2001;286:1317-1324.

  4. Gender Differences in the Prevalence of PAD 6880 Consecutive Patients (61% Female) in 344 Primary Care Offices 18 16 Women 14 Men 12 10 Prevalence (%) 8 6 4 2 0 <70 70–74 75–79 80–84 >85 Age (years) Adapted from Diehm C. Atherosclerosis. 2004;172:95-105 with permission from Elsevier.

  5. PAD: More Prevalent Than Many Leading Diseases 17 Disease Prevalence (Millions) 12.6 12 8.9 5 4.8 4 Source: American Cancer Society, American Heart Association, Alzheimers Disease Education/Referral Center, American Diabetes Association, SAGE Group

  6. Reduced Increased Risk Factors for PAD Smoking Diabetes Hypertension Hypercholesterolemia Hyperhomocysteinemia Renal insufficiency Age (per 10 years) 0 1 2 3 4 5 6 RelativeRisk Hirsch AT, et al. J Am CollCardiol. 2006;47:e1-e192.

  7. Diabetes Increases the Risk of PAD 25 22.4* 19.9* 20 15 12.5 Prevalence of PAD (%) 10 5 0 Normal GlucoseTolerance Impaired Glucose Tolerance Diabetes Impaired glucose tolerance was defined as oral glucose tolerance test value ≥140 mg/dL but <200 mg/dL. *P.05 vs. normal glucose tolerance. Lee AJ, et al. Br J Haematol. 1999;105:648-654.

  8. Individuals “At Risk” for Lower Extremity PAD Based on the epidemiologic evidence, an “at risk” population for PAD can be defined as: • Age <50 years with diabetes, and one additional risk factor (e.g., smoking, dyslipidemia, hypertension, or hyperhomocysteinemia) • Age 50 to 69 years and history of smoking or diabetes • Age ≥70 years • Leg symptoms with exertion (suggestive of claudication) or ischemic rest pain • Abnormallower extremity pulse examination • Known atherosclerotic coronary, carotid, or renal artery disease ACC/AHA PAD Guidelines 2011

  9. Right ABI 80/160=0.50 Left ABI 120/160=0.75 ABI (Normal >0.90) Highest brachial SBP Brachial SBP 160 mm Hg Brachial SBP 150 mm Hg PT SBP 120 mm Hg PT SBP 40 mm Hg Highest of PT or DP SBP DP SBP 80 mm Hg DP SBP 80 mm Hg Using the Ankle-Brachial Index (ABI) ABI=ankle-brachial index; DP=dorsalis pedis;PT=posterior tibial; SBP=systolic blood pressure.

  10. Interpreting the Ankle-Brachial Index ACC/AHA PAD Guidelines 2011

  11. Ankle Brachial Index (ABI) Arch Intern Med. 2003;163:884-892

  12. PARTNERS: Prevalence of PAD and Other CVD in Primary Care Practices 29% of Patients in a Target Population Were Diagnosed With PAD Using An Office-Based ABI 44% 29% 56% Patients diagnosed with PAD PAD only PAD and CVD ABI=ankle-brachial index; CVD=cardiovascular disease. Hirsch, AT et al. JAMA. 2001;286:1317-24.

  13. Association Between ABI and All‑Cause Mortality* N=5748 Risk increases at ABI values below 1.0 and above 1.4 Total Mortality (%) Baseline ABI Age range=mid- to late-50s; ABI=ankle-brachial index; *Median duration of follow-up was 11.1 (0.1–12) years. O’Hare AM et al. Circulation. 2006;113:388-393.

  14. 1%-2% Critical Limb Ischemia (CLI) Clinical Presentation of PAD Do you have leg pain? ~15% Classic (Typical) Claudication 50% Asymptomatic ~33% Atypical Leg Pain(functionally limited) • Claudication: impairs patient quality of life by causing painful cramps and dysfunction while walking • CLI: rest pain, non-healing or poorly healing ulcers, or gangrene

  15. 100 75 50 25 0 2 4 6 8 10 12 Long-Term Survival in Patients With PAD 624 men and women who were residents of a predominantly white, upper-middle-class community in southern CA Normal subjects Asymptomatic PAD Survival (%) Symptomatic PAD Severe symptomatic PAD Year Criqui MH et al. N Engl J Med. 1992;326:381-386.

  16. Natural History of Atherosclerotic Lower Extremity PAD PAD Population (50 years and older) Initial clinical presentation Asymptomatic PAD 20%-50% Atypical leg pain 40%-50% Claudication 10%-35% Critical limb ischemia 1%-2% 1-year outcomes Progressive functional impairment Amputation 25% CV mortality 25% Alive w/ 2 limbs 50% 5-year outcomes (to next slide) Hirsch AT, et al. Circulation. 2006;113:e463-654.

  17. Natural History of Atherosclerotic Lower Extremity PAD For each of these PAD clinical syndromes Asymptomatic PAD 20%-50% Claudication 10%-35% Atypical leg pain 40%-50% 5-year outcomes Limb morbidity CV morbidity & mortality Mortality 15%-30% Nonfatal CV event (MI or stroke) 20% Stable claudication 70%-80% Worsening claudication 10%-20% Critical limb ischemia 1%-2% Amputation (see CLI data) CV causes 75% Non-CV causes 25% Hirsch AT, et al.Circulation. 2006;113:e463-654. CLI=critical limb ischemia; CV=cardiovascular; MI=myocardial infarction

  18. PAD: More Prevalent and MoreDeadly Than Many Leading Diseases Disease Prevalence (Millions) Five-Year Mortality Rate 17 39% 12.6 12 30% 28% 8.9 21% 5 14% 4.8 4 ColorectalCancer BreastCancer PAD Stroke CAD Source: American Cancer Society, American Heart Association, Alzheimers Disease Education/Referral Center, American Diabetes Association, SAGE Group

  19. Prevalence of Abnormal ABI in Patients with Established CAD ABI=0.9-1.4 (38.7%) ABI<0.9 (58.4%) ABI>1.4 (2.9%) Banerjee et al. ACC 2013

  20. Cardiovascular Events Based on ABI Values and Presence of Diabetes Mellitus p=0.006 p=0.40 p=0.29 Repeat coronary revascularization Death MACE Stroke Non-fatal myocardial infarction Banerjee et al. ACC 2013

  21. Freedom From MACE Hazard ratio (HR) and 95% confidence interval (CI) for MACE in patients with: DM and normal ABI (HR=1.7, 95% CI: 0.71-4.06, P=0.24) no DM and abnormal ABI (HR=2.03, 95% CI: 0.83-4.98, P=0.12) and DM with abnormal ABI (HR=4.85, 95% CI: 2.22-10.61, p=0.0001) compared to the reference or control group (no DM and normal ABI) DM: diabetes mellitus ABI: ankle-brachial index Banerjee et al. ACC 2013

  22. Cardiovascular Events in Patients with PAD • Potential reasons for excess CV events: • Increased vasospasm • Increased burden of ‘vulnerable’ atheroma • Systemic vascular inflammation • Reduced fibrinolytic activity • Hypercoagulability • Reduced positive vascular remodeling Lumen Atheroma Lumen Vessel wall Ann Surg 1984;199:223-33

  23. Progression of Coronary Atherosclerosis in PAD Serial Intravascular ultrasound assessments 3,479 patients with CAD from 3 statin RCT 216 with PAD & 3,263 without concomitant PAD Change in % atheroma volume +0.58 ± 0.38 p = 0.009 +0.23 ± 0.3 - remodelling + remodelling CAD: coronary artery disease PAD: peripheral arterial disease Hussein et al. J Am CollCardiol, 2011; 57:1220-1225

  24. Benefit from LDL Reduction Retained in PAD 3,479 patients with CAD from 3 statin RCT 216 with PAD & 3,263 without concomitant PAD • Serial Intravascular ultrasound • Assessments: • More extensive atherosclerosis • Greater calcifications • More constrictive remodeling • Greater disease progression of atherosclerosis • PAD patients retain the ability to derive a benefit from intensive risk modification strategies Change in Total atheroma volume (mm3) –1.6 ±1.0 LDL<70 PAD LDL<70 No PAD LDL>70 No PAD LDL>70 PAD 1.0 ± 1.4 CAD: coronary artery disease PAD: peripheral arterial disease LDL: low density lipoprotein –3.3 ± 1.1 –3.0 ± 1.9 p = 0.04 p < 0.001 Hussein et al. J Am CollCardiol, 2011; 57:1220-1225

  25. CAPRIE – study design • 19185 patients with recent IS, recent MI or established PAD • Clopidogrel 75 mg od versus aspirin 325 mg od • Follow-up of 1–3 years (mean 1.91 years) • Combined primary endpoint of IS, MI or vascular death CAPRIE Steering Committee. Lancet 1996;348:1329–1339.

  26. CAPRIE – efficacy profile of clopidogrel 8.7% relative risk reduction, p = 0.043 160 Event rate per year 120 Placebo3 * 7.7% Event rate/1000 patients/year 77 80 Aspirin1 5.8% 19 24 58 Clopidogrel1 5.3% 53 40 * extrapolated curve 3 Based on the APTC findings,2 in a population similar to CAPRIE, for each 1000 patients treated per year, aspirin can be expected to prevent 19 events and clopidogrel, 24.1 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Time from Randomization (Months) 1CAPRIE Steering Committee. Lancet 1996;348:1329–1339. 2Antiplatelet Trialists' Collaboration. BMJ 1994;308:81–106. 3Fisher LD. J Am Coll Cardiol 1998;31(Suppl A):49A.

  27. I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III AntiplateletTherapy in PAD Antiplatelet therapy is indicated to reduce the risk of CV events. Clopidogrel only as an alternative to Aspirin. Antiplatelet therapy is indicated to reduce the risk of CV events in asymptomatic individuals withABI 0.91-0.99 (C); ABI<0.91 (A) c Aspirin + Clopidogrel (75 mg per day) to reduce the risk CV events, not at an increased risk of bleeding. B ACC/AHA PAD Guidelines 2011

  28. Effect of Smoking Cessation on Survival 133 Patients observed after bypass graft or lumbar sympathectomy Cumulative Survival (%) Years Postoperative Faulkner KW, et al. Med J Aust. 1983;1:217-219.

  29. 10 mg 125 100 80 mg Placebo 75 50 25 0 Atorvastatin in Patients With Claudication and PAD n=354 ABI<0.9 or 20% decrease in exercise ABI LDL<160 mg/dl * Mean change from baseline in PFWT (sec) Baseline Month 3 Month 6 Month 12 PFWT=pain-free walking time.*P=.03. No change in ABI over 12 months. MohlerER et al. Circulation. 2003;108:1481-1486.

  30. Intensive Antihypertensive Therapy in PAD: The ABCD Trial Moderate treatment n = 227 50 Intensive treatment n = 227 *enalapril or nisoldipine 40 30 Odds are calculated using moderate treatment and a baseline ABI of 1.0 as a reference Odds of MI, Stroke or Vascular Death 20 10 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 Baseline ABI ABCD: Appropriate Blood Pressure Control in Diabetes Mehler, et al. Circulation. 2003;107;753-756.

  31. Difficulties for treatment specific to the femoro-popliteal segment Hostile environment for stent implantation Extension / Contraction Flexion Torsion Compression

  32. Endovascular Interventional Toolbox Laser Silverhawk Cryoplasty Nitinol self-expanding Stents

  33. Mean 1-year data 2-year data 3-year data 4-year data 5-year data Durability of Endovascular Procedures Primary Patency (%, 95% CI) 40 60 80 100 0 20 Iliac PTA Iliac Stent Femoropopliteal PTA Femoropopliteal Stent Infrapopliteal PTA CI=confidence interval; PTA=percutaneous transluminal angiography Hirsch AT, et al. J Am CollCardiol. 2006;47:e1-e192.

  34. Claudication Treatment Comparative Effectiveness (CLEVER Study 6m) Peak Walking Time (min) Change from baseline at 6m Claudication Onset Time (min) Change from baseline at 6m 3.6 3.0 0.7 Pair-wise comparisons Pair-wise comparisons Stenting QOL > ExerciseQOLor Medical RxQOL Hirsch et al. AHA 2011 “Late-breaking Trial

  35. IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I IIa IIa IIa IIa IIb IIb IIb IIb III III III III I I I C Revascularization for Claudication Endovascular intervention is not indicated as prophylactic therapy in an asymptomatic patient with lower extremity PAD. There is no evidence that any symptomatic clinical outcome can be improved, or adverse limb event averted (including amputation) by any prophylactic revascularization method, including angioplasty or vascular surgical bypass.

  36. Cardiology Surgery

  37. Interdisciplinary Approach to PAD Antiplatelet Surgical Statin PTA-Surgical Bridge ACE Cilostazol Endovascular Smoking cessation Exercise

  38. Take Home Message • PAD is a common, yet serious, disease that raises the risk of heart attack and stroke • PAD is not always symptomatic and may be silent in a vast majority of patients • Evaluation of PAD should be part of routine physical examination • Appropriate and timely interventions (medical & revascularization) can significantly improve cardiovascular outcomes

  39. http://www.xlpad.org/

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