Author + information
- Received February 14, 2019
- Revision received April 12, 2019
- Accepted April 15, 2019
- Published online July 8, 2019.
- Francesco Liistro, MDa,∗ (, )@FrancescoLiist1,
- Paolo Angioli, MDa,
- Italo Porto, MD, PhDb,
- Kenneth Ducci, MDa,
- Giovanni Falsini, MDa,
- Giorgio Ventoruzzo, MDa,
- Lucia Ricci, MDa,
- Alessia Scatena, MDa,
- Simone Grotti, MDa and
- Leonardo Bolognese, MDa
- aCardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy
- bCardiovascular Unit, Policlinico San Martino IRCCS, Università di Genova, Genoa, Italy
- ↵∗Address for correspondence:
Dr. Francesco Liistro, Cardiovascular Department, San Donato Hospital, 52100 Arezzo, Italy.
Background Drug-eluting technologies improve 12-month angiographic results of femoropopliteal (FP) interventions, but few data on the comparison between drug-coated balloons (DCBs) and drug-eluting stents (DES) are available.
Objectives The aim of this study was to compare, after balloon pre-dilation, a strategy of DCB followed by provisional self-expanding nitinol bare-metal stent implantation with a strategy of systematic DES implantation in patients at high risk for FP restenosis.
Methods Patients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention were randomly assigned 1:1 to DCB or DES after successful target lesion pre-dilation. The primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and from major amputation.
Results A total of 192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included. Diabetes and critical limb ischemia were present in >50% in both groups. Mean lesion length was 14 cm, and baseline target lesion occlusion reached about 60% of cases in both groups. The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions. Twelve-month target lesion restenosis was observed in 22% of DCB-treated versus 21% of DES-treated patients (p = 0.90). Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (p = 0.50).
Conclusions DCB was not superior to DES in the treatment of complex FP lesions in a high-risk population, yielding similar rate of restenosis and clinically driven target lesion revascularization. (Paclitaxel-Eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-Eluting Stent for the Treatment of Femoropopliteal De Novo Lesions; NCT01969630)
Dr. Liistro is a consultant for Medtronic as a member of the Advisory Board for drug elution strategies and principal investigator for the IN.PACT BTK study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received February 14, 2019.
- Revision received April 12, 2019.
- Accepted April 15, 2019.
- 2019 American College of Cardiology Foundation