This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.
Age 18 years or older, gender is not limited.
Patients diagnosed with arteriosclerosis obliterans.
Rutherford stages 2-6.
When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
Malignant tumor
Alzheimer's disease
Blood disease or bleeding tendency
Heart Failure Grade III ~ IV
lower extremity arteriosclerosis obliterans
Cohort
Prospective
open bypass group
Procedure/SurgeryAfter heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction.
bare metal stent group
Procedure/SurgeryBare metal stent implantation during the index procedure.
plain old balloon angioplasty group
Procedure/SurgeryOnly plain old balloon was used during the index procedure.
drug-coated balloon group
Procedure/SurgeryDrug-coated balloon was used during the index procedure.
directional atherectomy group
Procedure/SurgeryDirectional atherectomy (with or without drug-coated balloon) during the index procedure.
hybrid repair group
Procedure/SurgeryFemoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed.
6
Treatment groupsSee each treatment group below.
Limb salvage rate
Freedom from above ankle amputation in target limb.
Primary patency rate
Primary patency of target lesion is assessed by the vascular ultrasound.
Major adverse limb event (MALE) rate
Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb.
All cause mortality rate
Death due to any cause.
Restenosis of the target lesion
A peak systolic velocity ratio of over 2.4 measured using duplex ultrasound, \>50% diameter stenosis or occlusion by follow-up angiography.
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events include anyone of the following: Major amputations, myocardial infarction, ischemic stroke, arterial puncture problems requiring intervention, and acute kidney failure associated with endovascular therapy.
Quality-adjusted life-years (QALYs)
Time is measured in years and the VascuQol (Vascular Quality-of-Life, scored on a scale from 1 to 7 by using the VascuQol-25 questionnaire) on an index scale ranging from 1 (worst possible) to 7(best possible). The total number of QALYs was calculated by multiplying the HRQoL index score (QALY weight) by the time spent in each health state. One QALY can be viewed as living for 1 year in the best possible health.
Survival Rate
Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status.
Clinically-driven target lesion revascularization (CD-TLR)
Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
Wound healing
The wound diameter and ulcer grade.
Incremental cost effectiveness ratio (ICER)
The difference in costs are divided by the difference in QALY or VascuQol.
Improvement of dietary and life style
The dietary habits and lifestyle of the patients were collected by questionnaire before operation. Before discharge, patients received education on healthy diet and lifestyle, and information on diet and lifestyle was collected at follow-up.
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