DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Popliteal Artery Stenosis
- Sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
- Enrollment
- 143
- Primary Endpoint
- Primary latency 12-months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.
Detailed Description
Atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall. Moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, DAART), theoretically might further improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind" strategies have gained support among interventionalist. Many studies claim that atherectomy improves results when combined with adjunctive DCB. The Supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. It mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions. The purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.
Investigators
Enrique M. San Norberto
MD, PhD, MSc, MPGCert
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Eligibility Criteria
Inclusion Criteria
- •patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up
Exclusion Criteria
- •Exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. Other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.
Outcomes
Primary Outcomes
Primary latency 12-months
Time Frame: 12 months
primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions
Secondary Outcomes
- Amputation rate(12-months)
- Secondary Patency(12-months)
- Stent fracture(12-months)
- Clinical status(12-months)
- Mortality(12-months)
- ABI measurement(12-months)
- Primary-assisted patency(12-months)