DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery143 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

143

Conditions

Popliteal Artery Stenosis Atheroma

Interventions

DAARTDEVICE

ATP/Supera stentingDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

Time frame: 12 months

Secondary Outcomes

Secondary Patency

Secondary patency was defined as requiring a secondary intervention to restore patency after occlusion of the treated segment

Time frame: 12-months

Mortality

Patients dead all-cause during follow-up

Time frame: 12-months

Amputation rate

Patients with minor or mayor amputation during follow-up

Time frame: 12-months

Clinical status

Rutherford classification clinical scale after 12-month follow-up

Time frame: 12-months

ABI measurement

Ankle/Brachial index measurement.

Time frame: 12-months

Stent fracture

Stent fracture and implantation defects were assessed by high-resolution radiographic imaging performed on the stents of every limb

Time frame: 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

Data from ClinicalTrials.gov

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