PAD IS A MAJOR GLOBAL HEALTH PROBLEM Michael S. Conte MD Division - PowerPoint PPT Presentation

4/17/2015 Treatment of Claudication: Perspectives of the Patient, the Provider and the Health Care System PAD IS A MAJOR GLOBAL HEALTH PROBLEM Michael S. Conte MD Division of Vascular and Endovascular Surgery UCSF Medical Center UCSF Vascular Symposium 2015 10-Year Natural History in Patients With REACH Registry: One Year Costs Associated with Hospitalizations for Intermittent Claudication Vascular Reasons 100 80 PAD TREATMENT MORE Patients (%) 60 COSTLY THAN CAD! Survival MI 40 Intervention Amputation 20 0 0 1 2 3 4 5 6 7 8 9 10 Ouriel K. Lancet. 2001;358;1257-1264. Time (years) 1

4/17/2015 Medicare Payments Surge for Stents to Unblock Blood Vessels in Limbs NY Times Do the results justify the utilization? Business Day Jan 29, 2015 Are we spending too much on treatments 3-fold increase in PTA • that provided limited benefit for a benign procedures for IC 1997-2007 This is only the Inpatient Data condition?? • J Vasc Surg 2011; 54:1021 IF YOU WERE A PAD PATIENT: IF YOU WERE THE DECISION-MAKER FOR A What is the minimum efficacy threshold you MAJOR PAYOR: would accept for an invasive treatment for life- What is the minimum efficacy threshold you style limiting claudication? would expect to justify the costs of an invasive treatment for life-style limiting claudication? A. >50% likelihood of improvement 67% A. >50% likelihood of improvement for at least one year 65% for at least one year B. >50% likelihood of improvement B. >50% likelihood of improvement for at least two years 20% for at least two years 13% 19% C. >50% likelihood of improvement 16% C. >50% likelihood of improvement for at least three years for at least three years 2

4/17/2015 Treatment Goals in IC Disability in IC: Not So Benign Historical data suggests that “ clinical deterioration ” occurs in � Reduce secondary CV events • 20-30% of pts with IC � Prevent/reduce likelihood of disease progression • More recent evidence using objective testing suggests that on to CLI and potential amputation (overall low risk) average ambulatory function significantly worsens over time in � Reduce IC-related disability PAD, with increasing levels of disability during follow-up – McDermott et al WALCS Trial (N=460) � Improved walking ability in daily life – Multiple measures of functional performance, 5 years of f/u � Improve self-perceived QoL – Adjusted HR 2.29 for inability to complete a six-minute walk at 5 � Maximize symptom-free survival year f/u visit � Maintain independent function – Greater declines associated with older age, higher BMI, lower baseline ABI, less daily physical activity, pulmonary disease, � Minimize interventions (frequency and severity), spine disease, diabetes morbidity, hospitalizations, and overall costs • Paucity of functional data using validated assessment � “Right patient, right time, right procedure” tools IC Treatment “Paradigm Shifts” IC Therapy: Comparative Effectiveness � Few studies have compared the impact of revascularization, � Old paradigm medical therapy, or exercise on functional and QoL outcomes � Stop Smoking and Exercise � Supervised exercise, endovascular and open � Surgery or Intervention for Selected Patients revascularization all appear superior to medical therapy � Low comorbidities/risk assessment paramount � Favorable lesion anatomy for treatment � Revascularization has greater effects on blood flow; surgical � Durability a key measure of success treatments have higher morbidity but greater durability � “ Let ’ s do some imaging and take a look ” � New paradigm � Spronk et al randomized 151 pts to PTA first or SE PTA pts had reduced ipsilateral symptoms at 6 months but no � difference in clinical, functional capacity or QoL at 6,12 months � Endovascular interventions have lowered the entry bar � MIMIC Trial- PTA associated with improved walking � Broadly disseminated parameters vs SE at 24 months � Generally low procedural risk, but Costly � Recent Cochrane reviews: � Technical success high; overestimates clinical success � Gains for both exercise and PTA appear short term � Limited durability but may be repeated � Inadequate number of high quality studies � Unclear effects on clinical/anatomic disease progression, or on � Value of surgical bypass also questioned the outcomes of subsequent revascularization � Cl audication: E xercise V s E ndoluminal R evascularization � Potential risk of “Treatment Trap” (CLEVER) Trial 3

4/17/2015 “ “ “ “ Stop Smoking and Start Walking!! ” ” ” ” Effects of Exercise Training on Claudication Meta-analysis of 21 Studies 200 * Exercise Training Change in Treadmill Walking 180 Control 160 Distance (%) 140 * 120 100 80 60 40 * P < 0.05 20 0 Onset of Maximal Claudication Pain Claudication Pain Gardner AW, Poehlman ET. JAMA . 1995;274:975-980. Efficacy of Supervised Exercise: Results of a Meta-Analysis Exercisers Controls Change Pain-Free Walking 180% 40% 2 blocks • Predictors of improvement Distance – >6 months ’ exercise training – Moderate claudication pain Maximal Walking – Walking exercise 130% 30% 3 blocks Distance – Supervised exercise Gardner AW. JAMA. 1995;274:975-80. 4

4/17/2015 • Multicenter RCT comparing Optimal Medical Therapy (OMT), OMT plus Supervised Exercise (SE), and OMT plus Stenting (ST) for the treatment of Intermittent Claudication secondary to Aorto-iliac Occlusive Disease • N=119 subjects • Both SE and ST were both superior to OMT for measures of walking performance, QoL • Peak walking time (treadmill) was greater for SE than ST • QoL measures showed greater improvement for ST than SE Murphy T, et al. Circulation 2013 Br J Surg 2013 Options for TASC C/D SFA Disease Estimated 2-yr Patency (%) POBA 20-30 CLAUDICATION MATH for Bilateral SFA Disease: PTA+ BMS (or DES) 30-60 Patency 1 st limb at 2 years= 0.6 Atherectomy +/- adjunct 30-50 Patency 2 nd limb at 2 years = 0.6 40-60 Endoluminal stent graft Likelihood of Clinical Success at 2 years: Fem-Pop Bypass Grafting -- if you assume you need anatomic success in two legs= 0.36 !! 70-80 Vein (AK or BK) Prosthetic (AK) 65-80 Prosthetic (BK) 40-60 5

4/17/2015 What Does the Patient Want? • Reassurance they are not likely to lose their limb • Better understanding of the underlying disease and how they can exert some control over its progression • Improved limb function and associated QoL • Avoid/minimize invasive procedures, hospitals, and physician visits • Avoidance of other atherosclerotic CV complications J Vasc Surg 2012;55:1001-7 . What Does the Provider Want? What Does the “Health System” Want? • A happy, compliant patient • A happy, compliant patient • A good outcome • A good outcome at low cost • Significant, durable gains for patients with the • Significant, durable gains for patients with the greatest disability greatest disability • Enhanced reputation and associated referrals • Enhanced reputation of the health plan • ADDRESS EDUCATION, LIFESTYLE, MEDICAL • PROVIDE RESOURCES FOR EDUCATION, THERAPY AND EXERCISE PRIMARILY LIFESTYLE, MEDICAL THERAPY AND EXERCISE • CAREFULLY SELECT PTS FOR REVASCULARIZATION AND INFORM THEM • INCENTIVIZE APPROPRIATE SELECTION OF PROPERLY OF THE LIMITATIONS, RISKS AND PTS FOR REVASCULARIZATION BENEFITS 6

4/17/2015 Treatment of IC: Current State Emphasis on optimal medical therapy, smoking cessation and regular � exercise for the majority of patients Engage the patient in measuring performance, and reassure them on � low risk of limb loss Reserve revascularization for severe disability, failure to improve after � adequate trial of conservative measures Patient comorbidities/risk, anatomic pattern of disease, prior � interventions, and conduit availability influence treatment choice and expected outcomes Strategy for intervention should be based on a reasonable estimate of � clinical durability, e.g. at least 50% likelihood of sustained success for 2 or more years. Anatomic patency necessary though not sufficient. Shared decision making requires adequate pt education re trade-offs � Evidence-based practice hampered by scarcity of high quality RCTs � and comparative effectiveness studies, particularly with patient- centered outcomes assessment 7