DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

Study 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.

Official Title
-----------------
DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY ATHEROSCLEROTIC LESIONS: A CASE-MATCH PROPENSITY STUDY

Conditions
-----------------
Popliteal Artery Stenosis, Atheroma

Intervention / Treatment
-----------------
* Device: DAART
* Device: ATP/Supera stenting


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DAART<br>Popliteal artery lesion treated by directional atherectomy with anti-restenotic therapy for the treatment of popliteal atherosclerotic lesions. | Device: DAART<br> <br> |
| ATP/Supera stenting<br>Angioplasty and Supera stent implantation for the treatment of popliteal atherosclerotic lesions. | Device: ATP/Supera stenting<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary latency 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Patency | Secondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment | 12-months | 
| Mortality | Patients dead all-cause during follow-up | 12-months | 
| Amputation rate | Patients with minor or mayor amputation during follow-up | 12-months | 
| Clinical status | Rutherford classification clinical scale after 12-month follow-up | 12-months | 
| ABI measurement | Ankle/Brachial index measurement. | 12-months | 
| Stent fracture | Stent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb | 12-months | 
| Primary-assisted patency | Primary assisted patency was defined as a patent popliteal segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency | 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Popliteal artery, Drug-coated balloon, Supera stent, Directional atherectomy