Claudication Exercise vs. Endoluminal Revascularization
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1 Claudication Exercise vs. Endoluminal Revascularization Anthony J. Comerota, MD, FACS, FACC Director, Jobst Vascular Institute Adjunct Professor of Surgery, University of Michigan
2 Disclosures NIH Research Funds Investigator: CLEVER Trial
3 PAD: Natural History Patient Outcome PAD Population >55 yrs Asymptomatic ABI <0.9 50% Claudication 40% Critical Leg Ischemia 10% Patients 5-yr Other with Cardiovascular intermittent Morbidity/ claudication Mortality are not at risk for limb loss! Nonfatal CVD (MI/Stroke) 20% Limb Loss 2% 5 Year Mortality 15-25% Weitz Jl, et al. Circulation. 1996;94:
4 Peripheral arterial disease Intermittent Claudication The Benefit of Exercise
5 Lower Extremity Arterial Occlusive Disease Claudication: Rx with Exercise 35 years ago Supervised Physical Training Author Pts Improved Average Increase Ekroth et al Surgery % 234% Clifford et al Br Med J % 80%
6 - Contemporary Analysis - Vascular Medicine 2015;20:30-40
7 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Purpose Quantify whether HRQOL is improved through exercise training in people with PAD Quantify magnitude of change in WIQ in exercise trained participants Parmenter, BJ et al Vas Med 2015;20:30-40
8 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Methods 1. Randomized controlled trials of: Exercise training vs usual care 2. Included: Walking impairment questionnaire (WIQ) Short-form health survey trials with 1257 Participants Supervised exercise 61 - Resistance training Unsupervised exercise Usual care-controls Parmenter, BJ et al Vas Med 2015;20:30-40
9 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Results WIQ Speed P< Parmenter, BJ et al Vas Med 2015;20:30-40
10 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Results WIQ Distance P< Parmenter, BJ et al Vas Med 2015;20:30-40
11 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Results WIQ Stair-Climbing P< Parmenter, BJ et al Vas Med 2015;20:30-40
12 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Results WIQ Physical Component Scoce Figure 6 P = Parmenter, BJ et al Vas Med 2015;20:30-40
13 Exercise training for health-related quality of life in peripheral artery disease: A systematic review and meta-analysis Belinda J Parmenter1, Gudrun Dieberg 2, Glenn Phipps 2, Neil A Smart 2 Results Summary Exercise improved WIQ Speed P < WIQ Distance P < WIQ Stair Climbing P < SF Physical Component P =.001 Exercise training vs. other non-op care. Parmenter, BJ et al Vas Med 2015;20:30-40
14 Eur J Vasc Endovasc Surg 2011; 42:220
15 Methods 201 patients with IC > 6 months Aorto-iliac and infrainguinal disease Randomized: Exercise/best medical care vs. Exercise/best medical care plus intervention Primary outcome: Max walking performance at 2yrs Secondary outcome: Not Supervised Exercise! HRQOL ABI change at 2yrs Nordanstig J et al Eur J Vasc Endovasc Surg 2011; 42:220
16 Results Intervention Group Patency at 2 years 70% Suprainguinal 49% Infrainguinal 51% Open Surgery 53% Endovascular 47% Nordanstig J et al Eur J Vasc Endovasc Surg 2011; 42:220
17 Primary Endpoint at 24 Months - Maximal Walking Performance - Nordanstig J et al Eur J Vasc Endovasc Surg 2011; 42:220
18 Results Self Reported Walking Distance at 24 Months - Median - Exercise Invasive 100m 100m Nordanstig J et al Eur J Vasc Endovasc Surg 2011; 42:220
19 Supervised Exercise Vs. Primary Stenting for Claudication Due to Aortoiliac Peripheral Artery Disease: 6 Month Outcome From the CLEVER Study - NIH Sponsored Trial - NCT Murphy T and the CLEVER Investigators Circulation 2012; 125:130-39
20 The CLEVER Study: Aorto-Iliac Disease Hypothesis - Based on Preliminary Data - The relative treatment benefit in patients having angioplasty/stenting for aortoiliac occlusive disease would be 30% greater than structured exercise Murphy T et al Circulation 2012; 125:130-39
21 The CLEVER Study: Aorto-Iliac Disease Methods 111 patients with moderate/severe IC due to aortoiliac occlusive disease Multicenter Randomized: Optimal medical care (OMC) vs. OMC plus supervised exercise vs. OMC plus angioplasty/stenting Primary endpoint: Change PWT at 6 months Secondary endpoints: Change in Claudication onset time HRQOL Free living step activity CV risk factors (biomarkers) Murphy T et al Circulation 2012; 125:130-39
22 The CLEVER Study: Aorto-Iliac Disease Methods Anthropomophic and physiologic variables (BMI, waist circum., blood pressure) Graded treadmill exercise test (Gardner protocol) 7-day pedometer log - Baseline Evaluation - CV risk factors: Lipid profile Fibrinogen HgbA1c hscrp Quality-of-life measures SF-12 Walking impairment questionnaire Peripheral artery questionnaire repeated at 6 months Murphy T et al Circulation 2012; 125:130-39
23 The CLEVER Study: Aorto-Iliac Disease Methods Primary Endpoint: Peak walking time at 6 months Secondary Endpoints: Claudication onset time Community based walking Self-reported walking Quality-of-life Biomarkers of CV disease Murphy T et al Circulation 2012; 125:130-39
24 The CLEVER Study: Aorto-Iliac Disease Primary Endpoints - Change in PWT at 6 Months (min.) OMC SE+OMC ST+OMC (N=20) (N=38) (N=41) 56% Increased in PWT 1.2 ± ± ± 4.9 Comparison p-value ST vs. OMC SE vs. OMC <0.001 SE vs. ST Murphy T et al Circulation 2012; 125:130-39
25 The CLEVER Study: Aorto-Iliac Disease Secondary Endpoints Endpoints at 6mos Exercise Stent p-value Change in COT (Min.) Free-living steps/hour ABI from Baseline <.0001 QOL Physical Multiple Measures <.04 Murphy T et al Circulation 2012; 125:130-39
26 The CLEVER Study: Aorto-Iliac Disease Secondary Endpoints HDL (increase) SE vs. ST p=0.013 Fibrinogen (decrease) Potential impact on future SE vs. OMC p=0.043 ischemic events ST vs. OMC N.S. Murphy T et al Circulation 2012; 125:130-39
27 The CLEVER Study: Aorto-Iliac Disease Conclusions For patients with Intermittent Claudication: 1. Supervised exercise provides superior improvement in walking performance compared to endovascular stenting at 6 months 2. SE benefit is associated with improved selfreported walking distance, an increase HDL and decrease in fibrinogen (CV risk factors) Murphy T et al Circulation 2012; 125:130-39
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29 Claudication Exercise vs. Endoluminal Revascularization Anthony J. Comerota, MD, FACS, FACC Director, Jobst Vascular Institute Adjunct Professor of Surgery, University of Michigan
30 Conclusions 1. Maximal walking distance, and patient self-reported walking distance similar between groups 2. Patient perceived QOL better with early intervention Nordanstig J et al Eur J Vasc Endovasc Surg 2011; 42:220
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