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Balloon angioplasty (PTA) remains the most commonly used primary or adjunctive device in treating femoropopliteal arteries (FP). PTA however can cause uncontrolled dissections leading to flow limitation and excessive bailout stenting. A no-stent strategy in the era of drug coated balloons is highly desirable. In this study we present data on patients pretreated with focal-force scoring balloons prior to Lutonix® DCB (Bard Peripheral Vascular).
This study is a subgroup analysis of patients pretreated with cutting /scoring balloons (cutting balloon, AngioSculpt or VascuTrak) prior to Lutonix® DCB in the SAFE-DCB prospective, multi-center US registry. This registry evaluated 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. 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. 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.
Of 1006 subjects at 79 sites in the US enrolled by September of 2017, 602 and 200 subjects completed follow up at 30-day and 6-month respectively. Of those who completed 30-day follow up, pre- Lutonix® DCB dilatation was performed with cutting /scoring balloons in 77 patients of which 28 were VascuTrak cases. At 6-months, data was available for 25 subjects in the cutting balloon/scoring group of which 16 were VascuTrak cases. The mean lesion length was 70.7 mm (75.1 mm VascuTrak) respectively. Acute device and procedure success (i.e., <30% residual stenosis of the target lesion after treatment and no complications prior to hospital discharge) was 84.4% (85.7% VascuTrak). Among the 602 subjects enrolled, 4.3% had major flow limiting dissections; however, there were no major dissections in the overall cutting/scoring balloon subgroup. At 30 days, target lesion revascularization (TLR) and target vessel revascularization (TVR) were 1.3% and 2.6% respectively for the cutting /scoring balloon group (0% and 0% for VascuTrak). Device-related serious adverse events (SAE) were 0%. At 6-month and post 30-day follow up, TLR and TVR were 0% and 0% respectively. Device-related SAE were 0%. All-cause death occurred in 0% of the cutting /scoring balloon group.
Preliminary data from a subgroup analysis of the SAFE-DCB US registry showed high procedural and device success, low TLR and TVR, and low device-related SAE using focal-force scoring balloons. Of particular note, the use of the VascuTrak balloon pre- Lutonix® DCB demonstrated no TLR or TVR, SAEs, or patient deaths at 6 months. A larger registry for cutting/scoring balloon pre-DCB is need to validate these early observations.