SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.
SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.
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.
Inclusion Criteria:

 1. Age 18 years or older;

 2. Disabling claudication as defined by surgeon based on patient's history;

 3. Ankle/Brachial Index (ABI) < 0.9 or drop in ABI > 0.15 after exercise test;

 4. Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning
 (CDS) (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on Magnetic Resonance Angiography (MRA) or
 Computed Tomography Angiography (CTA)(> 50% stenosis) or occlusion of the common or
 external iliac artery on CDS (PSV 0 m/s) or on MRA or CTA;

 5. Iliac artery lesion and a concomitant stenosis in the superficial femoral artery
 defined as stenosis > 50% by CDS (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on MRA or CTA,
 or occlusion on CDS (PSV 0 m/s) or MRA or CTA;

 6. Lesion classified A, B or C according to the TASC (TransAtlantic Inter-Society
 Consensus) classification of aortoiliac lesions;

 7. Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline;

 8. The Maximum Walking Distance on a treadmill < 300 meters.

 Exclusion Criteria:

 1. Life expectancy < 3 months;

 2. Patient is unable to complete self-reported questionnaires (insufficiently reading or
 speaking the Dutch language, cognitive disorders, etc);

 3. Patient is unable to give informed consent;

 4. A documented contrast allergy;

 5. Pregnancy;

 6. Contra-indication for anticoagulant therapy;

 7. Duration of current complaints < 3 months;

 8. Occlusion of the common femoral artery at the affected side;

 9. Patient participates in another study;

 10. Heart failure or Angina Pectoris NYHA III or IV. (NYHA III: Marked limitation of
 physical activity. Comfortable at rest, but less than ordinary activity causes
 fatigue, palpitation, or dyspnea; NYHA IV: Unable to carry out any physical activity
 without discomfort. Symptoms of cardiac insufficiency at rest. If any physical
 activity is undertaken, discomfort is increased);

 11. Patient previously received Supervised Exercise Therapy (SET) according to KNGF (Dutch
 Society for Physiotherapists) guidelines;

 12. Renal insufficiency (serum creatinin > 150 micromol/l).