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 |
36 months (within 1,080 days) |
|---|---|
| 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 |
Evaluate the safety and effectiveness of the AbreTM Venous Self-expanding Stent System, intended for the treatment of symptomatic iliofemoral venous outflow obstruction |
|---|---|
| Sample size |
200 subjects |
| Initial clinical presentation |
Acute DVT (aDVT), post-thrombotic syndrome (PTS), and nonthrombotic iliac vein lesion (NIVL) |
| Follow-up |
1, 6, 12, 24, and 36 months |
| Study design |
|
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) |
| Hypercoagulable condition |
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) |
63.0 ± 28.6 |
| 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 AbreTM 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) |
Additional resources
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*
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.
Reference
1
Source: AbreTM Stent Instructions for Use.