Critical Limb Ischemia, Intermittent Claudication, Peripheral Arterial Disease
Conditions
Keywords
Critical limb ischemia, Intermittent claudication, endovascular treatment, drug-elution
Brief summary
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.
Interventions
PROCEDURERevascularization with drug-eluting technology
Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).
PROCEDURERevascularization without drug-eluting technology
Endovascular intervention without using drug-eluting balloons or stents
DEVICEdrug-coated balloons and/or drug-eluting stents
Sponsors
The Swedish Research Council
Swedish Heart Lung Foundation
Uppsala University
The Swedish National Registry for Vascular Surgery
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adults \> 18 years old willing to be randomized * Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by \>50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications
Exclusion criteria
* Acute thromboembolic disease in the leg * Infrainguinal aneurysmal disease * Previous participation in the study or in other randomised interventional study of infrainguinal lesions * Patients without a Swedish personal identification number
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amputation rate (SWEDEPAD 1) | Assessed when all patients have been followed for at least one year | 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. |
| Health-related quality of life (SWEDEPAD 2) | Assessed one year after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion revascularization (TLR) | Assessed one year after the intervention and when all participants have been followed for one, three and five years. | Need for re-intervention during follow-up |
| Time to target lesion revascularization | Assessed one year after the intervention and when all participants have been followed for one, three and five years. | — |
| Patency | Assessed after 1 month and 1 year | 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). |
| Amputation-free survival | Assessed when all participants have been followed for at least one, three and five years. | — |
| Health-related quality of life (SWEDEPAD 1) | Assessed after one year following randomisation | Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6 |
| Amputation rate (SWEDEPAD 2) | Assessed one year after the intervention and when all participants have been followed for one, three and five years | — |
| Health-economic assessment | Assessed one year after the intervention and when all participants have been followed for one, three and five years | Assessment of cost-effectiveness and clinical utility (only certain centres). |
| Improvement in clinical symptoms, assessed with the Rutherford classification | Assessed after one month and one year | 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) |
| Survival | Assessed when all participants have been followed for at least one, three and five years. | — |
Countries
Sweden
Outcome results
None listed