ABRE clinical study 36-month data

Site and core lab data were used.

EQ5D is a generic quality of life (QoL) questionnaire that assesses the subjects’ health status on that day on a range of 0–1 (worst health to best health).

VEnous INsufficiency Epidemiological and Economic Study (VEINES) is a disease-specific QoL instrument for use in venous diseases of the leg.

Villalta score categorizes the severity of PTS (score > 5 diagnoses PTS; score > 14 categorizes severe PTS). Symptoms of PTS assessed by Villalta include pain, heaviness, clinical signs such as skin induration and redness, and presence of venous ulcers.

Venous clinical severity score (VCSS) measures venous disease severity over time and in response to treatment. VCSS scores range from 0, indicating no disease, to 30, indicating severe disease.

Primary patency was defined as meeting all of the following criteria: freedom from occlusion of the stented segment of the target lesion, freedom from restenosis ≥ 50% of the stented segment of the target lesion, and freedom from clinically driven target lesion revascularization.

MAEs included all-cause death, clinically significant pulmonary embolism, post-procedural major bleeding complication, stent thrombosis, and stent migration. MAEs were adjudicated by a clinical events committee, except stent thrombosis and stent migration, which were assessed by an imaging core laboratory.

Safety end points (MAE and its component events, TLR and Major Bleeding): % is cumulative incidence based on Kaplan-Meier (number of subjects with an event).

TLR was defined as any reintervention of the stented segment of the target lesion.

Fracture or breakage of any portion of the stent verified by core lab via X-ray.

Position change of a venous stent > 1 cm from its original location at the conclusion of the index procedure, as determined with regard to a reference anatomic structure, as verified by core labs.

Primary effectiveness end point was primary patency at 12 months post-procedure, defined as meeting all of the following: freedom from occlusion and ≥ 50% restenosis of the stented segment of the target lesion and freedom from clinically driven target lesion revascularization.

Primary safety end point was MAEs within 30 days post-procedure, including all-cause death, clinically significant pulmonary embolism, major procedural bleeding complication, stent thrombosis, and stent migration. MAEs were adjudicated by a Clinical Events Committee, except stent thrombosis and stent migration, which were assessed by an imaging core laboratory.

Data from IVUS.

Source: Abre stent Instructions for Use.