We improve the quality of life of your patients.
*Data has been provided by Shekarchian et al.3
STEVECO – the first randomized, controlled trial that proves why venous stenting should be considered a therapy.
Patients with post-thrombotic syndrome are severely restricted in their daily lives due to pain. The STEVECO study compares venous stenting with BMT (Best Medical Treatment) and evaluates VEINES-QoL/VEINES-Sym, VCSS and PDI over a period of 12 months.
91%
PTS-Patients included in study
12months
randomized, controlled trial (RCT)
91.4%
primary patency
with PTS Patients
97.2%
secondary patency
with PTS Patients
What makes the STEVECO study so different?
- STEVECO compares conservative/best medical treatment (BMT) with dedicated vein stenting in an equivalent study scenario and patient population and evaluates the quality of life following each treatment approach.
- The endpoints of the study were selected to identify the benefits of conventional treatment options (BMT) and not solely – like in other trials – that the stenting is working in a patient.
- One of the main obstacles in the enrollment process was the willingness of the participants to be treated conservatively for over one year with BMT before being considered for additional stenting.
(Maastricht University Medical Center+)
Great results – despite all challenges
[1] STEVECO trial calls into question randomisation in the venous stenting field (venousnews.com)
(Maastricht, The Netherlands)
Before STEVECO, the quality of the evidence was limited due to the lack of control groups. STEVECO has improved the evidence base for the provision of such treatment.
Most reports focus on stent safety and patency, only a few studies report on patients’ quality of life.
Secondary Patency
97.2%
The optimed studies (STEVECO & TOPOS) include a very high percentage of PTS patients during the enrollment process.
PTS is considered to be difficult and lowering overall patency scores – STEVECO shows that optimed-stents have higher (compared to other studies) patency rates in the same population.2
Venous Stenting was associated with improved the quality of life (QoL). This study showed statistically a significant reduction in VCSS score in stent group compared to the control group.
[2] Lichtenberg, Michael et al. ”Braided nitinol stent for chronic iliofemoral venous disease – the real-world BLUEFLOW registry.” VASA. Zeitschrift für Gefäßkrankheiten vol. 50,5 (2021): 372-377. doi:10.1024/0301-1526/a000953
back to an active life
Dedicated venous stenting for desired improvement
12 month Follow-up data shows that included number of PTS patients might affect patency results.
12 MONTHS FOLLOW-UP PRIMARY PATENCY
| Study name | STEVECO (optimed) |
TOPOS (optimed) |
| Study design | Randomized controlled Trial (RCT) |
Prospective multi-center single-arm study |
| Stent | sinus-Venous | sinus-Obliquus sinus-Venous sinus-XL Flex |
| PP all patients (%) |
91.4 % | 84.2 % |
| PP subgroup PTS (%) |
90.0 % | 84.2 % |
| aPP (%) | 94.2 % | |
| SP (%) | 97.2 % | |
| Included PTS patients (%) |
91.0 % |
12M Follow-up results for patency in comparison to other published clinical studies, Data on file at optimed, data approximated
w/o decimal point for graphical reasons
Assisted primary patency (aPP) was defined as flow inthe stent lumen after additional stenting or PTA because of stenosis (> 50 %) with related clinicalsymptoms.
Secondary patency (SP) was defined as < 50 % stenosis after additional thrombolysis, thrombectomy restenting, or PTA because of previous stent occlusion, and without the creation of an AVF.
Data has been provided by Shekarchian et al.3
[3] Shekarchian, Soroosh et al. “Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up.” European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery, S1078-5884(23)00610-X. 28 Jul. 2023, doi:10.1016/j. ejvs.2023.07.044
sinus-Venous
More flexibility with a verifiable improvement in quality of life
The sinus-Venous stent is a hybrid stent that connects multiple closed-cell segments to combine a high level of flexibility with radial strength. The vascular stent system is used for symptomatic obstructions (DVT, PTS) of the femoral or iliac veins.
Optimed venous stents
For the treatment of various venous diseases such May-Thurner Syndrome, venous outflow obstructions or Vena cava syndrome.
sinus-Venous
For the treatment of deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS)
sinus-Obliquus
For the treatment of May-Thurner syndrome (MTS)
sinus-XL Flex
Flexible open-cell stent for the treatment of symptomatic obstructions affecting the iliofemoral venous outflow or venous return to the heart from the superior or inferior Vena cava (Vena cava syndrome)
STEVECO-related publications
VAN VUUREN ET AL.
Source (1): van Vuuren, Timme Maj et al. »A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol.« BMJ open vol. 7,9 e017233. 11 Sep. 2017, doi:10.1136/bmjopen-2017-017233
SHEKARCHIAN ET AL.
Source (3): Shekarchian, Soroosh et al. »Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up.« European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery, S1078-5884(23)00610-X. 28 Jul. 2023, doi:10.1016/j.ejvs.2023.07.044
ABBREVIATIONS & ACRONYMS
STEVECO
Venous Stenting Versus Conventional Treatment
BMT
Best Medical Treatment
VEINES-QoL
Venous Insufficiency Epidemiological and Economic Study-Quality of Life
VEINES-Sym
Venous Insufficiency Epidemiological and Economic Study-Quality of Symptoms
VCSS
Venous Clinical Severity Score
PDI
Pain Disability Index
RCT
Randomized controlled trial
PTS
Post-thrombotic Syndrome
PP
Primary Patency
aPP
Assisted Primary Patency
SP
Secondary Patency
PTA
Percutaneous Transluminal Angioplasty
DVT
Deep Vein Thrombosis
AVF
Arteriovenous Fistel
for more flexibility in everyday life
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