Author + information
- Received January 18, 2017
- Revision received March 29, 2017
- Accepted April 19, 2017
- Published online August 21, 2017.
- Marcus Thieme, MDa,b,∗ (, )
- Peter Von Bilderling, MDc,
- Christian Paetzel, MDd,
- Dimitrios Karnabatidis, MDe,
- Julio Perez Delgado, MDf,
- Michael Lichtenberg, MDg,
- Lutonix Global SFA Registry Investigators
- aRegiomed Vascular Center Sonneberg, Sonneberg, Germany
- bJena University Hospital, Jena, Germany
- cDiakoniewerk Munchen, München, Germany
- dKliniken Nordoberpfalz AG, Weiden, Germany
- eUniversity Hospital of Patras, Patras, Greece
- fArberlandklinik Viechtach, Viechtach, Germany
- gKlinikum Arnsberg, Karolinen-Hospital Huesten, Arnsberg, Germany
- ↵∗Address for correspondence:
Dr. Marcus Thieme, Department of Angiology/Cardiology/Diabetology, Regiomed Vascular Center Sonneberg, Neustadter Strasse 61, 96515 Sonneberg, Germany.
Objectives The Global SFA Registry sought to assess safety, clinical benefit, and outcomes of the Lutonix 035 drug-coated balloon (DCB) in a heterogeneous, real-world patient population at 12 and 24 months.
Background Numerous clinical studies have evaluated the use of angioplasty for revascularization of femoropopliteal arteries in peripheral arterial disease with restenosis rates of 40% to 60% at 6 to 12 months. Data from recent studies document decreased restenosis rates and improvement in patency in patients receiving angioplasty of femoropopliteal arteries with DCBs.
Methods The multicenter, prospective study enrolled 691 patients in 38 centers from 10 countries treated with the Lutonix 035 DCB in femoropopliteal lesions. The primary safety endpoint was freedom from a composite of target vessel restenosis, major index limb amputation, and device- or procedure-related death at 30 days. The primary effectiveness endpoint was freedom from target lesion restenosis at 12 months. Secondary endpoints were acute device and procedural success and clinically assessed primary patency.
Results Freedom at 30 days from the composite safety endpoint was 99.4%. Freedom from target lesion restenosis was 93.4%/89.3% for the overall population, 93.2%/88.2% for long lesions up to 500 mm, and 90.7%/84.6% for in-stent restenosis at 12/24 months. Clinically assessed primary patency by Kaplan-Meier estimates was 85.4%/75.6% at 12/24 months. More than 76% of patients showed improvement of at least 1 Rutherford category.
Conclusions The Global SFA Registry 24-month outcomes confirm the Lutonix 035 DCB is a safe and effective long-term treatment option in real-world patients with peripheral arterial disease with superficial femoral artery lesions, also in long lesions and in-stent restenosis. (Lutonix Global SFA Registry; NCT01864278)
Dr. Thieme is a consultant for and has received symposium honoraria from C.R. Bard. Dr. von Bilderling has received consulting fees/honoraria and grants/research support from C.R. Bard. Dr. Karnabatidis has received consultancy payments and grants/research support from C.R. Bard, Medtronic, Rontis, and Boston Scientific. Dr. Lichtenberg has received consultant/proctor and symposium honoraria from C.R. Bard. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 18, 2017.
- Revision received March 29, 2017.
- Accepted April 19, 2017.
- 2017 American College of Cardiology Foundation