BIO4AMB Trial Evaluates Biotronik’s 4-F Devices in Treating Ambulatory PAD

September 17, 2020—Biotronik announced that new clinical data from the BIO4AMB trial demonstrate that 4-F–compatible devices are a valid, safe option for endovascular treatment of ambulatory lower extremity peripheral artery disease and show similar results to 6-F devices, with the added benefit of eliminating the need for a vascular closure device.

The BIO4AMB multicenter controlled trial compared the rate of access site complications and major adverse events in 4-F versus 6-F femoral access endovascular interventions.

According to the company, the full-cohort analysis of 766 patients showed no significant differences in safety and efficacy between the patient group treated with 6-F devices and the group treated with Biotronik’s 4-F product portfolio. The portfolio includes the Pulsar-18 and Pulsar-18 T3 self-expanding stent systems, the Fortress reinforced introducer sheath system, the Passeo-18 Lux drug-coated balloon catheter, and the Passeo-18 percutaneous transluminal angioplasty balloon catheter.

Professor Marianne Brodmann, MD, presented the data at the Cardiovascular and Interventional Radiological Society of Europe’s CIRSE 2020 Summit held online September 12-15. Prof. Brodmann, who is with the Department of Angiology at the Medical University in Graz, Austria, serves as Coprincipal Investigator of the trial.

“Compared to the already well-established 6-F devices, 4-F–compatible devices were shown to be a valid alternative,” commented Prof. Brodmann in Biotronik’s announcement.

The rate of freedom from access site complications was 97.2% in the 4-F arm and 96.8% in the 6-F arm (P = .734). Prof. Brodmann highlighted a key difference, noting, “Use of 4-F 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.”

Also, at CIRSE 2020, Coprincipal Investigator Professor Jos van den Berg, MD, presented findings from a health economic evaluation of the BIO4AMB study that investigated the implications on safety, resource use, and cost of lower extremity peripheral treatment using 4-F and 6-F access in an ambulatory setting. In this analysis, the rate of vascular closure device use was 0% in the 4-F arm versus 87.4% in the 6-F arm (P < .05).

“Depending on the country-specific reimbursement situation, ambulatory treatment may offer a cost-saving option compared to a stationary setting,” concluded Prof. van den Berg, who is Professor of Interventional Radiology at Ospedale Regionale di Lugano in Switzerland.