BUELACH, Switzerland - September 17, 2020—BIO4AMB Trial Results Demonstrate BIOTRONIK’s 4-French Portfolio to Be as Safe and Effective as 6-French Devices While Avoiding Additional Need of a Vascular Closure Device
Outcomes of the BIO4AMB trial presented at the CIRSE 2020 Summit demonstrated that ambulatory treatment with 4‑French (4F) devices is a valid and safe option for endovascular treatment of lower extremity peripheral artery disease (PAD). The 4F compatible products showed similar results to 6-French (6F) devices, with the added benefit of an eliminated need for a vascular closure device.
The BIO4AMB multicenter, controlled trial compared the rate of access site complications* and major adverse events in 4F versus 6F femoral access endovascular interventions. The full-cohort analysis of 766 patients showed no significant differences in safety and efficacy between the patient group treated with 6F devices and those treated with BIOTRONIK’s 4F product portfolio.
"Compared to the already well-established 6F devices, 4F compatible devices were shown to be a valid alternative," summarized Co-Principal Investigator Prof. Marianne Brodmann, Department of Angiology at the Medical University in Graz, Austria.The rate of freedom from access site complications was 97.2% in the 4F arm and 96.8% in the 6F arm (P = 0.734). Prof. Brodmann, who presented the data, highlighted a key difference: "Use of 4F sheaths creates 45% smaller puncture holes, which resulted in low rates of access site complications despite not needing vascular closure devices. This may offer a better potential for ambulatory treatment."
The health economic evaluation of the BIO4AMB study, also presented at CIRSE, investigated the implications on safety, resource use and cost of lower-extremity peripheral treatment using 4F and 6F access in an ambulatory setting. In this analysis, the rate of vascular closure device use was 0% in the 4F arm versus 87.4% in the 6F arm (P < 0.05).
"Depending on the country specific reimbursement situation, ambulatory treatment may offer a cost saving option compared to a stationary setting," concluded Co-Principal Investigator and presenter Prof. Jos van den Berg, Professor of Interventional Radiology, Ospedale Regionale di Lugano, Switzerland.
"The data presented at CIRSE further strengthen the value of 4F devices for safe and efficient treatment of patients with lower extremity PAD," noted Dr. Alexander Uhl, President Vascular Intervention at BIOTRONIK. "BIOTRONIK’s 4F peripheral portfolio offers a unique advantage when treating PAD patients in an ambulatory setting."
The BIOTRONIK 4F portfolio includes the Pulsar®-18 and Pulsar®-18 T3 self-expanding stent systems, Fortress® reinforced introducer sheath system, Passeo®-18 Lux drug-coated balloon catheter and Passeo®-18 percutaneous transluminal angioplasty balloon catheter.
1. Brodmann, M. Clinical outcomes of endovascular treatment of PAD for 4 French and 6 French femoral access strategies – full cohort analysis of BIO4AMB multicenter, controlled trial. Presented at: CIRSE 2020; September 7, 2020.
2. van den Berg, J.C. Impact of 4 French femoral access on resource use and cost – a health economic evaluation of the BIO4AMB study. Presented at: CIRSE 2020; September 1, 2020.
*Access site complications are defined as a composite of: Groin hematoma (larger than 5 cm in diameter, visible by sonography, and haemoglobin decrease <3 g/dL), Pseudoaneurysm, Groin as well as retroperitoneal bleeding (defined as requiring acute intervention for haemostasis, need for blood transfusions, or haemoglobin decrease > 3 g/dL), AV fistula (visible by shunting in colour coded sonography between the common femoral artery and vein), Arterial dissections at access site (visible with fluoroscopy or sonography as a membrane causing stenosis in the vessel lumen), Thrombosis 6- VCD related ASCs.
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