Microsoft powerpoint - clever primary results aha 2011_final-nopw.pptx

Claudication Treatment
Comparative Effectiveness:
Timothy P Murphy, Donald E. Cutlip, Judith G. Regensteiner, Emile R. Mohler III, David J. Cohen, Matthew R. Reynolds, Beth A. Lewis, Joselyn Cerezo, Niki C. Oldenburg, Claudia C. Thum, Alan T. Hirsch.
Alan T. Hirsch, Chair, on behalf of the CLEVER Study Investigators Acknowledgements and Disclosures
Acknowledgements: The CLEVER Study was sponsored by the National Heart
Lung and Blood Institute (grants HL77221 and HL081656), and also received
financial support from Cordis/Johnson & Johnson (Warren, NJ), eV3 (Plymouth,
MN), and Boston Scientific (Natick, MA).

Otsuka America, Inc., (San Francisco, CA) donated cilostazol for all study
participants throughout the study. Omron Healthcare Inc., Lake Forest, IL donated
pedometers. Krames Staywell, San Bruno, CA, donated print materials for study
participants on exercise and diet.

Disclosures: Timothy P. Murphy, M.D.: Research grant support - Abbott Vascular,
Cordis/Johnson&Johnson, Otsuka Pharmaceuticals; consultant -
Microvention/Terumo, Inc.; David Cohen, M.D.: Research grant support -
Medtronic. Boston Scientific, Abbott Vascular, Medrad; consultant - Medtronic,
Inc.; Matthew R. Reynolds, M.D., M.Sc. : Consultant - Medtronic, Inc.; Alan T.
Hirsch, MD.: Research Grant Support - Cytokinetics, Viromed, Abbott Vascular;
consultant - Merck, Pozen, Novartis, AstraZeneca.

 Claudication is the most frequent symptom of peripheral artery disease (PAD), and is experienced by an estimated 2 million Americans  Current therapeutic options include home exercise; supervised exercise; claudication pharmacotherapy (cilostazol); or endovascular procedures  Invasive stent procedures have not been shown to offer better claudication improvement than supervised exercise; stenting is reimbursed, but supervised exercise is not  Patients with proximal (aortoiliac) PAD are often highly symptomatic, and are generally considered ideal for stent revascularization Study Objectives
1. To test whether aortoiliac stenting (ST) and supervised exercise therapy (SE) are superior to optimal medical care (OMC) -- as measured by peak walking time (PWT) at 6 months -- in patients with claudication due to aortoiliac peripheral arterial disease (PAD). 2. If these comparisons are positive, to test whether stenting is superior to supervised exercise for the same endpoint.
 Moderate to severe claudication (2-11 min on Gardner treadmill protocol or up to 5.5 METS)  Hemodynamically significant aortoiliac PAD confirmed by non-invasive vascular lab testing or advanced imaging  No other co-morbid diseases that limited walking  No critical limb ischemia (rest pain, non-healing wound or  SFA disease allowed and endovascular treatment permitted by protocol, but not required in any patients Treatment Strategies
Optimal Medical Care (OMC):
 Cilostazol 100 mg bid as tolerated, written and oral advice
about exercise and diet, with monthly coordinator contact Supervised Exercise (SE):
 OMC plus 78 sessions of supervised exercise, 3x/wk, for 1
Stenting (ST):
 OMC plus stent revascularization of aortoiliac PAD
Primary Endpoint:
 Peak Walking Time (PWT) on a graded treadmill test
Secondary Endpoints:
 Claudication Onset Time (COT)
 Community-based walking by pedometer
 Quality of life (QOL) by WIQ, PAQ, SF-12
 Atherosclerosis biomarkers
Primary Endpoint Assessed at Six (6) Months
 Eighteen (18) months long-term follow-up pending
Demographic and Medical History Characteristics
Age, years
Diabetes (%)
Hypertension (%)
Current smoking (%)
Hypercholesterolemia (%)
Prior stroke (%)
Prior myocardial infarction (%)
Prior use of cilostazol (%)
Baseline Physiologic, Biochemical,
and Anthropomorphic Characteristics
Blood Pressure and ABI
SBP (mmHg)
DBP (mmHg)
Ankle-Brachial Index
Biochemical Profile
LDL (mg/dl)
HDL (mg/dl)
48±15 0.94
Triglycerides (mg/dl)
HbA1c (%)
Anthropomorphic Characteristics
Waist Circumference (cm)
Baseline Performance Characteristics
Treadmill Walking
PWT (minutes)
COT (minutes)
Community-based Walking
Hourly Free-Living Steps
Treatment Delivery
Cilostazol Compliance:
 >90% in all treatment groups
Exercise Compliance:
 71%
Technical Success of Stenting:
 All ST patients successfully stented
 Pre-procedure mean lesion length 3.9±3.4 cm
 Mean stenosis 83±19%; post-procedure stenosis 5±8%
 ABI 0.66±0.2 at baseline, improved by 0.29±0.33
Crossover Rates:
 None at six months
Primary Endpoint: Peak Walking Time
Change from Baseline to Six (6) Months
Pair-Wise Comparisons
Difference (minutes)
Exercise vs. OMC
4.6 (95% CI, 2.7-6.5)
Stenting vs. OMC
2.5 (95% CI, 0.6-4.4)
Exercise vs. Stenting
2.1 (95% CI, 0.0-4.2)
Claudication Onset Time
Change from Baseline to Six (6) Months
Pair-Wise Comparisons
Difference (minutes)
Exercise vs. OMC
Stenting vs. OMC
Exercise vs. Stenting
Community Walking
Change from Baseline to Six (6) Months
Pair-Wise Comparisons
Difference (steps)
Exercise vs. OMC
Stenting vs. OMC
Exercise vs. Stenting
Walking Impairment Questionnaire
Change from Baseline to Six (6) Months
SE vs. OMC
ST vs. OMC
Peripheral Artery Questionnaire
Change from Baseline to Six (6) Months
SE vs. OMC
ST vs. OMC
 In patients with moderate to severe claudication and hemodynamically significant aortoiliac disease, supervised exercise offers better treadmill walking performance outcomes than stent revascularization  Both supervised exercise and stenting are more effective at increasing walking distance compared to pharmacotherapy alone  Aortoiliac stent revascularization was associated with better QOL scores than patients treated with supervised exercise, which is unexplained  Ongoing 18 month follow-up will provide greater insight into the relative durability of these treatments, as well as the health economic impact CLEVER Study Sites
Rhode Island Hospital in Providence, RI (Tim Murphy)
Henry Ford Hospital in Detroit, MI (Jonathan Ehrman)
VA Ann Arbor in Ann Arbor, MI (Venkat Krishnamurthy)
Aiyan Diabetes Center in Evans, GA (Janaki Nadarajah)
University of Minnesota & Abbott Northwestern Hospital in Minneapolis, MN (Alan T. Hirsch)
Jobst Vascular Center in Toledo, OH (Anthony Comerota)
Torrance Memorial Medical Center in Torrance, CA (Mark Lurie)
Vascular and Endovascular Specialist of Ohio in Mansfield, OH (William Miller)
Ochsner Clinic in Metairie, LA (Olusegun Osinbowale)
Spokane-Providence Medical Center in Spokane, WA (Stuart Cavalieri)
St. Joseph Hospital in Orange, CA (Mahmood Razavi)
Forsyth - Salem Surgical in Salem, NC (Ray Workman)
Capital Health in Halifax, NS (Robert Berry)
Johns Hopkins Hospital in Baltimore, MD (Elizabeth Ratchford)
Stony Brook Hospital in Stony Brook, NY (Apostolos Tassiopoulos)
University of Pennsylvania in Philadelphia, PA (Emile Mohler)
Oregon Health Science University in Portland, OR (John Kaufman)
Iowa Clinic in Des Moines, IA (John Matsuura)
Peripheral Vascular Associates in San Antonio, TX (Jeffrey Martinez)
Central Arkansas Veterans Health Care in Little Rock, AR (Mohammed Moursi)


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