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BeGraft Peripheral PMCF Study: 12-month results
Koen Deloose1, Marc Bosiers2, Joren Callaert2
1A.Z. Sint-Blasius, Dendermonde, Belgium - koen.deloose@telenet.be.
Insights
Covered stents show high primary patency (94.4%) and freedom from revascularization (96.7%) at 12 months in aortoiliac lesions. This supports their use in vascular interventions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Prospective, non-randomized BeGraft Peripheral Post-Market Clinical Follow-up (PMCF) study conducted in Belgium.
- Reports 12-month follow-up data for a cohort of patients undergoing aortoiliac interventions.
- Primary endpoint: primary patency at 12 months, defined by Duplex ultrasound and absence of target lesion revascularization (TLR).
Purpose of the Study:
- To evaluate the 12-month efficacy of covered stents in treating aortoiliac lesions.
- To assess primary patency and freedom from target lesion revascularization (TLR) in a real-world setting.
Main Methods:
- 70 patients with TASC II Class A-D aortoiliac lesions were enrolled between June 2014 and March 2015.
- Mean lesion length was 34.3 mm with an average stenosis of 83.16%.
- Data analysis focused on primary patency and freedom from TLR at 12-month follow-up.
Main Results:
- The overall primary patency rate at 12 months was 94.4%.
- Freedom from target lesion revascularization (TLR) at 12 months was 96.7% for the entire patient cohort.
Conclusions:
- The findings support the efficacy and positive clinical outcomes of using covered stents for aortoiliac interventions.
- Further research with longer follow-up periods and more complex lesion subsets is warranted to expand understanding.
Background:
The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months.
Methods:
Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%.
Results:
Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%.
Conclusions:
These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future.
