Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation). In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies. In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,556
Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).
Endovascular intervention without using drug-eluting balloons or stents
Sahlgrenska University Hospital
Gothenburg, Sweden
Amputation rate (SWEDEPAD 1)
Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year.
Time frame: Assessed when all patients have been followed for at least one year
Health-related quality of life (SWEDEPAD 2)
Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD.
Time frame: Assessed one year after randomization
Amputation-free survival
Time frame: Assessed when all participants have been followed for at least one, three and five years.
Survival
Time frame: Assessed when all participants have been followed for at least one, three and five years.
Target lesion revascularization (TLR)
Need for re-intervention during follow-up
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Time to target lesion revascularization
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Patency
Patency, defined as freedom from binary restenosis, a reduction in lumen diameter ≥50% in patients assessed with duplex ultrasound after one month and after one year (only certain centres).
Time frame: Assessed after 1 month and 1 year
Improvement in clinical symptoms, assessed with the Rutherford classification
Particularly changes from Rutherford categories 4, 5 and 6 to lower categories will analysed (SWEDEPAD 1) Particularly changes from Rutherford categories 2 and 3 to other categories will analysed (SWEDEPAD 2)
Time frame: Assessed after one month and one year
Health-related quality of life (SWEDEPAD 1)
Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6
Time frame: Assessed after one year following randomisation
Amputation rate (SWEDEPAD 2)
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years
Health-economic assessment
Assessment of cost-effectiveness and clinical utility (only certain centres).
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years
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