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Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study.
J Am Coll Cardiol 2019; 74(2):205-215JACC

Abstract

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).

Authors+Show Affiliations

Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy. Electronic address: francescoliistro@hotmail.com.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular Unit, Policlinico San Martino IRCCS, Università di Genova, Genoa, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31296293

Citation

Liistro, Francesco, et al. "Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: the DRASTICO Study." Journal of the American College of Cardiology, vol. 74, no. 2, 2019, pp. 205-215.
Liistro F, Angioli P, Porto I, et al. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. J Am Coll Cardiol. 2019;74(2):205-215.
Liistro, F., Angioli, P., Porto, I., Ducci, K., Falsini, G., Ventoruzzo, G., ... Bolognese, L. (2019). Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. Journal of the American College of Cardiology, 74(2), pp. 205-215. doi:10.1016/j.jacc.2019.04.057.
Liistro F, et al. Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: the DRASTICO Study. J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. PubMed PMID: 31296293.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study. AU - Liistro,Francesco, AU - Angioli,Paolo, AU - Porto,Italo, AU - Ducci,Kenneth, AU - Falsini,Giovanni, AU - Ventoruzzo,Giorgio, AU - Ricci,Lucia, AU - Scatena,Alessia, AU - Grotti,Simone, AU - Bolognese,Leonardo, PY - 2019/02/14/received PY - 2019/04/12/revised PY - 2019/04/15/accepted PY - 2019/7/13/entrez KW - DCB KW - DES KW - restenosis SP - 205 EP - 215 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 74 IS - 2 N2 - 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). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/31296293/Drug-Eluting_Balloon_Versus_Drug-Eluting_Stent_for_Complex_Femoropopliteal_Arterial_Lesions:_The_DRASTICO_Study L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(19)35168-X DB - PRIME DP - Unbound Medicine ER -