SAFE-DCB US Registry’s Final 36-Month Data Presented for BD’s Lutonix 035 DCB

November 1, 2023—SAFE-DCB is a prospective, multicenter, single-arm, real-world registry in the United States assessing the clinical use, safety, and outcomes of the Lutonix 035 drug-coated balloon (DCB; BD Interventional) in the superficial femoral and popliteal arteries in a heterogeneous patient population in an on-label clinical use.

Nicolas Shammas, MD presented the final data from SAFE-DCB during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

In the SAFE-DCB study, 1,005 patients at 74 investigational sites were treated with the Lutonix 035 DCB and were followed to 36 months.

The primary effectiveness endpoint was freedom from target lesion revascularization (TLR) at 12 months.

The primary safety endpoint was freedom from composite of device- and/or procedure-related perioperative (≤ 30 day) death, target limb major amputation, and target vessel revascularization (TVR).

The secondary endpoints were freedom from TVR and TLR post–index procedure, rate of acute device and procedural success, primary patency at 12 months post–index procedure, freedom from composite of all-cause perioperative (≤ 30 day) death and from index limb amputation, reintervention and/or index limb–related death post–index procedure, and freedom from major amputation of the target limb.

As summarized in the VIVA press release, freedom from TLR at 12 months was 88.6%, and freedom from primary safety events at 30 days was 98.2%.

Dr. Shammas reported the following findings at 36 months:

• Freedom from TVR post–index procedure by Kaplan-Meier estimates was 69.5% and freedom from TLR post–index procedure was 74.4%. The rate of acute device and procedural success was 93.0%. Primary patency at 12 months post–index procedure by Kaplan-Meier estimates was 83.7%.
• Freedom from composite of all-cause perioperative (≤ 30 day) death and from index limb amputation, index limb reintervention, and index limb–related death post–index procedure by Kaplan-Meier estimates was 58.4%.
• Freedom from major amputation of the target limb post–index procedure by proportion-based counts was 95.6%.

The results from the SAFE-DCB United States registry demonstrate an 88.6% and 74.4% freedom from TLR at 12 and 36 months, respectively, and a high degree of safety of the Lutonix 035 DCB in this real-world heterogeneous population, concluded the study in the VIVA press release.