News Summary

• Even after treatment for peripheral artery disease, additional hospitalizations and associated costs increase substantially as the condition progresses.
• Public Health researcher Alan T. Hirsch, M.D., acted as senior author of the study, and also helped lead this international study on behalf of the Reduction of Atherothrombosis for Continued Health (REACH) Registry, which supplied the data for the study.

Quotes

“Many cardiovascular researchers have proven the risk associated with peripheral artery disease, but this study spotlights the dual clinical and very high economic costs that arise from this condition. These ongoing high costs mean that we can never be complacent in merely measuring the adverse outcomes associated with any particular disease. We clearly have to be committed to devising new treatments where none exist and in assuring that current treatments are being used for both maximum clinical benefit and best cost-effectiveness," said Alan T. Hirsch, M.D., School of Public Health professor of epidemiology and community health.

“We are dealing with clinically and economically severe consequences of PAD, a disease which is truly preventable. Our prior research estimated that vascular-related hospitalizations for PAD patients cost the United States $21 billion. Invasive treatment for PAD is costly, and a first invasive procedure becomes a risk factor for further procedures," said Elizabeth Mahoney, Sc.D., the study’s lead author.

Full Text

MINNEAPOLIS / ST. PAUL, Minn. (Oct. 13, 2010) – Even after initial procedures to clear blockages in leg arteries, additional hospitalizations and associated costs of peripheral artery disease (PAD) increase substantially as the condition progresses, according to new research reported in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.

University of Minnesota School of Public Health professor of epidemiology and community health Alan T. Hirsch, M.D., acted as senior author of the study, and also helped lead this international study on behalf of the Reduction of Atherothrombosis for Continued Health (REACH) Registry, which supplied the data for the study.

“Many cardiovascular researchers have proven the risk associated with peripheral artery disease, but this study spotlights the dual clinical and very high economic costs that arise from this condition,” Hirsch said. “These ongoing high costs mean that we can never be complacent in merely measuring the adverse outcomes associated with any particular disease. We clearly have to be committed to devising new treatments where none exist and in assuring that current treatments are being used for both maximum clinical benefit and best cost-effectiveness.”

“We are dealing with clinically and economically severe consequences of PAD, a disease which is truly preventable,” added Elizabeth Mahoney, Sc.D., the study’s lead author. “Our prior research estimated that vascular-related hospitalizations for PAD patients cost the United States $21 billion. Invasive treatment for PAD is costly, and a first invasive procedure becomes a risk factor for further procedures.”

About the Condition

PAD is a debilitating condition in which blood flow to the arteries in the legs is obstructed as a result of atherosclerosis, or the hardening and narrowing of the arterial walls. The condition affects an estimated 8 million Americans – a statistic researchers expect to increase. PAD is also associated with an elevated risk of major cardiovascular events, such as heart attack and stroke.

The prevalence of PAD is known from prior studies to increase from approximately 5 percent at age 50 to 10 percent by 65 and over 25 percent in patients 80 and older, researchers said.

About the Study

Among 25,763 U.S. participants in the REACH registry, researchers identified 2,396 (9.3 percent) with symptomatic PAD and 213 (0.8 percent) with asymptomatic PAD when they enrolled in 2003 and 2004.

Scientists defined PAD symptoms when claudication was present (a characteristic muscle discomfort in the lower extremities during exertion) with an ankle-brachial index (ABI) of less than 0.90; a history of lower-limb revascularization such as balloon angioplasty or stenting; or amputation.

The ABI is measured by comparing blood flow in the ankle to that in the arm to detect poor circulation. Patients were considered asymptomatic if they had an ABI of less than 0.90 without symptoms.

Researchers compared the rates of vascular-related hospitalizations and associated costs. One- and two-year follow-up data were available on 1,543 patients with symptomatic PAD and 134 patients with asymptomatic PAD.

Twenty-three percent of asymptomatic and 31 percent symptomatic PAD patients had at least one vascular-related hospitalization during the two-year study. Average cumulative 2-year hospitalization costs per patient were $7,000 for patients with a history of claudication; $7,445 for those with asymptomatic PAD; $10,430 for those with lower limb amputation; and $11,693 for those with a history of revascularization procedures.

“This high rate of hospitalizations would not be acceptable to most patients or physicians as an ideal course of care,” Hirsch said. “No one should assume that the first admission for a PAD procedure is a permanent resolution or ‘fix’ of the underlying condition. We have long recommended the use of the ankle-brachial index as an early diagnostic test followed by initiation of preventive strategies – including the adoption of a healthy lifestyle – to arrest or stall the progression of the disease and minimize the risk of adverse outcomes.”

When patients do present with claudication as a primary symptom of PAD, treatments should be selected based on the proven efficacy and cost-effectiveness, Hirsch said. Unfortunately, there has not been ideal information available that has allowed physicians to do so. These answers, he said, will likely come from the CLEVER study (Claudication: Exercise vs. Endoluminal Revascularization), sponsored by the National Heart, Lung and Blood Institute and managed by both the University of Minnesota and Brown University.

Sanofi-Aventis and Bristol-Myers Squibb funded the study. REACH is supported by Sanofi-Aventis, Bristol-Myers Squibb and the Waksman Foundation.