Peripheral Arterial Disease Clinical Trial
Official title:
SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction: A Randomized Controlled Trial. SUPER Study
The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of
two treatment strategies of Intermittent Claudication (IC) due to an iliac artery
obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous
Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.
It is our hypothesis that PTA as first line treatment is more effective than SET as first
line treatment with regard to maximum walking distance, quality of life and costs after one
year.
Intermittent claudication (IC) is a manifestation of cardiovascular disease, reflected by a
threefold increased risk in these patients of developing serious cardiovascular events.
Treatment of patients with IC is aimed at secondary prevention of cardiovascular events by
control of risk factors for atherosclerotic disease, and to improve walking distance and
subsequently quality of life. Supervised Exercise Therapy (SET) and Percutaneous Transluminal
Angioplasty (PTA) can effectively improve pain free walking distance, but the optimal choice
of treatment, specifically in patients with an iliac artery stenosis or occlusion is unclear.
PTA is attractive as initial therapy since PTA of the iliac arteries has an immediate effect
and it is durable. There is a lack of evidence from randomized controlled trials (RCT) to
define the optimal treatment strategy for patients with IC due to iliac artery lesions; first
line treatment with SET and PTA in case of failure, or immediate iliac artery PTA.
Purpose:
To define the optimal treatment strategy of IC due to an iliac artery obstruction: To start
with SET and deferred PTA in case of SET failure, or immediate PTA.
Design:
Multicenter randomized controlled trial.
Patients:
400 patients with IC due to an iliac artery stenosis or occlusion.
Interventions:
SET and PTA.
Outcomes:
Primary outcomes are quality of life (Qol) recorded with the disease specific VascuQol
instrument and maximum walking distance on a standardized treadmill test with a speed of 3.2
km/h at 10% incline after 1 year.
Secondary outcomes are pain-free walking distance, generic Qol, functional status,
complications, number of treatment failures and costs. Economic evaluation comprises a
cost-effectiveness and cost-utility analysis from a societal perspective, with the costs per
patient able to walk maximal, respectively the costs per Quality Adjusted Life-Year (QALY) as
outcome measures.
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