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Clinical evidence

Abre™ venous self-expanding stent system

View 36-month data from the ABRE clinical study for Abre™ venous self-expanding stent system.

The ABRE study difference: complex and diverse set of patients

47.5% categorized as PTS patients.
35.8% of PTS patients presented with complete vein occlusion.
44% of patients with stents extending below inguinal ligament.^†
112.4 mm average lesion length.

Quality of life and venous functional scores: EQ5D, VEINES, Villalta, VCSS

EQ5D index score^‡

VEINES-QoL^§

Villalta^◊

VCSS^¶

Primary patency^#

36-month patency

81.6%
overall

NIVL 97.1%
aDVT 76.5%
PTS 70.4%

24-month patency

86.2%
overall

NIVL 98.6%
aDVT 83.3%
PTS 76.8%

12-month patency

93.2%
overall

NIVL 98.6%
aDVT 100%
PTS 86.4%

Primary safety end point

98.0% freedom from MAEs at 30 days.^∆

Complications Cumulative incidence (based on Kaplan-Meier estimate)	36 months (within 1,080 days) N = 200 subjects
TLR^∞	16.3% (32)
MAE^∞	10.2% (20)
All-cause death occurring post-procedure	1.5% (3)
Clinically significant pulmonary embolism	2.1% (4)
Major bleeding complication (post-procedure)	0.5% (1)
Stent thrombosis	6.1% (12)
Stent migration	0.0% (0)
Major bleeding related to index procedure^∞	0.0% (0)

Secondary end points

83.7% freedom from TLR at 36 months.^††
0.0% stent fracture at 36 months.^‡‡
0.0% delayed stent migration at 36 months.^§§

Abre™ clinical study design

Purpose and indication	Evaluate the safety and effectiveness of the Abre™ venous self-expanding stent system, intended for the treatment of symptomatic iliofemoral venous outflow obstruction
Sample size	200 subjects
Initial clinical presentation	Acute DVT, post-thrombotic syndrome (PTS), and nonthrombotic iliac vein lesion (NIVL)
Follow-up	1, 6, 12, 24, and 36 months
Study design	Prospective, multicenter, single-arm Designed to meet literature-based performance goals: 12-month primary effectiveness endpoint^◊◊ 30-day primary safety endpoint^¶¶

Baseline demographics

Demographics	Included subjects
Age (years) (mean ± SD)	51.5 ± 15.9
Age (< 50 years)	41.5% (83/200)
Female	66.5% (133/200)
BMI (kg/m²) (mean ± SD)	29.5 ± 7.1

Baseline medical history

Medical history	Included subjects
Previous history of venous thromboembolism	52.0% (104/200)
Hypertension	31.0% (62/200)
Venous claudication	30.0% (60/200)
Known family history of DVT	22.0% (44/200)
Pulmonary embolism	17.0% (34/200)
Smoking (active)	12.0% (24/200)
Thrombophilia	11.5% (23/200)
Cancer (ongoing or remission)	11.0% (22/200)
IVC filter present	5.0% (10/200)

Procedural data

Assessment	Included subjects
Target limb — left	92% (184/200)
Reference vessel diameter (mm) (mean ± SD)	15.0 ± 2.7
% Area stenosis (mean ± SD)^##	74.9 ± 16.8
% Diameter stenosis (mean ± SD)	62.8 ± 28.7
Subjects with occluded lesions	25.6% (50/195)
Lesion length (mm) (mean ± SD)	112.4 ± 66.1
Total stented length (mm) (mean ± SD)	134.3 ± 58.0
Number of Abre™ stents implanted per subject	1.5 ± 0.6
Stented vein location^†
Common iliac vein	96.0% (192/200)
External iliac vein	80.5% (161/200)
Common femoral vein	44.0% (88/200)

Related links

† 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.

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