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SAFE-DCB is a prospective, multi-center registry designed to assess patient outcomes and safety following the use of the Lutonix® paclitaxel-coated angioplasty balloon (DCB) for the treatment of de-novo or restenotic lesions (non-stent) in the superficial femoral (SFA) or popliteal arteries (PA) in a real-world, heterogeneous patient population.
The SAFE-DCB US registry intended to enroll 1000 patients at 100 centers in the US. Patients with intermittent claudication or critical limb ischemia (Rutherford 2-6) and obstructive lesions of the SFA and PA up to 150 mm in length (reference vessel diameters 4-6 mm) were enrolled and treated with the Lutonix® DCB (Bard Peripheral Vascular). The primary effectiveness endpoint is freedom from target lesion revascularization (TLR) at 12 months, and the primary safety endpoint is a composite of device and/or procedure related perioperative (≤30 day) death, target-limb major amputation, and target vessel revascularization. Secondary endpoints include device and procedure success, primary patency (duplex ultrasound-derived; PSVR < 2.5) at 12 months, and freedom from TLR and major amputation at 6, 12, 24, and 36 months.
The registry completed enrolment of 1006 subjects at 79 sites in the US by September of 2016. A data snap shot was completed with 30-day and 6-month follow up data on the first 602 and 200 subjects respectively. The mean age was 68.8 ± 10.07 years and 56.5% were males. Mean lesion length was 78.5 ± 53.3 mm and 33.1% had limb ischemia (Rutherford 4-6). Chronic total occlusion was present in 29.1% and adjunctive stenting was performed in 17.1% of cases. Pre-DCB atherectomy was performed in 46.3% of lesions. Acute device and procedure success (i.e., <30% residual stenosis of the target lesion after treatment and no complications prior to hospital discharge) was 91.9%. At 30 days, target lesion revascularization (TLR) and target vessel revascularization (TVR) were 0.5% and 0.7% respectively. At 6 months, TLR and TVR were 4.3% and 5.9% respectively. Procedure-related and device-related serious adverse events (SAE) were 6.8% and 1.6% respectively.
Preliminary data from the SAFE-DCB US registry show high procedural and device success with low TLR and TVR and low device-related SAE.