Intermittent claudication is common in older individuals and often substantially limits physical activity. Physical activity levels in the elderly strongly predict cardiovascular and other morbidity. Despite claudication's prevalence, there remains controversy regarding the roles of revasculanzation and exercise therapy to improve physical functioning. The BROAD, LONG-TERM OBJECTIVE of the proposal is to optimize physical functioning, increase activity levels, and reduce cardiovascular disease risk in older individuals with peripheral arterial disease.
The SPECIFIC AIM of the proposed trial is to test the primary hypothesis that aortoiliac stenting/pharmacotherapy improves maximum walking duration (MWD) better than supervised exercise rehabilitation/exercise maintenance/pharmacotherapy for those with aortoiliac artery obstruction at 6 months.
Other aims are to compare these two treatment groups with a third group, usual care/pharmacotherapy, at 6 months, and to compare all 3 groups with regard to the following variables: MWD change score at 18 months, changes in free-living daily activity levels, patient-perceived quality of life, and cost-effectiveness. We also will perform exploratory analyses of demographic and biochemical risk factors for atherosclerosis, including BMI, blood pressure, lipid profile, HgbAlc, fibrinogen, and C-reactive protein. The HEALTH-RELATEDNESS of this project is that claudication is common in older individuals will increase in prevalence as our population ages, is chronic, and disabling. It limits physical activity and thereby increases cardiovascular disease risk. Optimum therapy is controversial, and varies by region and practitioner. The RESEARCH DESIGN AND METHODS is to divide 246 patients (at 9 study sites) with aortoiliac insufficiency and intermittent claudication randomly into 3 groups: usual care/pharmacotherapy, exercise rehabilitation/maintenance/pharmacotherapy, and stent/pharmacotherapy. Recruitment will be done over 28 months and patients will be followed for 18 months;the total study duration will be 5 years.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HL077221-05S2
Application #
8474868
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Goldberg, Suzanne H
Project Start
2005-08-15
Project End
2013-07-31
Budget Start
2010-08-01
Budget End
2013-07-31
Support Year
5
Fiscal Year
2012
Total Cost
$270,542
Indirect Cost
$55,239
Name
Rhode Island Hospital
Department
Type
DUNS #
075710996
City
Providence
State
RI
Country
United States
Zip Code
02903
Krishnamurthy, Venkataramu N; Naeem, Muhammad; Murphy, Timothy P et al. (2016) The effect of gender on outcomes of aortoiliac artery interventions for claudication. Clin Imaging 40:96-100
Murphy, Timothy P; Cutlip, Donald E; Regensteiner, Judith G et al. (2015) Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study. J Am Coll Cardiol 65:999-1009
Reynolds, Matthew R; Apruzzese, Patricia; Galper, Benjamin Z et al. (2014) Cost-effectiveness of supervised exercise, stenting, and optimal medical care for claudication: results from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial. J Am Heart Assoc 3:e001233
Murphy, Timothy P; Reynolds, Matthew R; Cohen, David J et al. (2013) Correlation of patient-reported symptom outcomes and treadmill test outcomes after treatment for aortoiliac claudication. J Vasc Interv Radiol 24:1427-35; quiz 1436
Murphy, Timothy P; Cutlip, Donald E; Regensteiner, Judith G et al. (2012) Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation 125:130-9
Murphy, Timothy P; Hirsch, Alan T; Cutlip, Donald E et al. (2009) Claudication: exercise vs endoluminal revascularization (CLEVER) study update. J Vasc Surg 50:942-945.e2
Murphy, Timothy P; Hirsch, Alan T; Ricotta, John J et al. (2008) The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg 47:1356-63
Dubel, Gregory J; Murphy, Timothy P (2008) Distal embolic protection for renal arterial interventions. Cardiovasc Intervent Radiol 31:14-22