Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.

Autor:	Deloose K; Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium., Bosiers M; Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium., Peeters P; Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium., Verbist J; Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium., Maene L; Department of Cardiovascular and Thoracic Surgery, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium., Beelen R; Department of Cardiovascular and Thoracic Surgery, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium., Keirse K; Department of Vascular Surgery, R.Z. Heilig-Hart, Tienen, Belgium., Hendriks J; Department Thoracic and Vascular Surgery, UZA, Edegem, Belgium., Lauwers P; Department Thoracic and Vascular Surgery, UZA, Edegem, Belgium., Wauters J; Vascular Research Department, Dendermonde, Belgium., Verschueren M; Vascular Research Department, Dendermonde, Belgium.
Jazyk:	angličtina
Zdroj:	Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists [J Endovasc Ther] 2020 Dec; Vol. 27 (6), pp. 936-945. Date of Electronic Publication: 2020 Sep 01.
DOI:	10.1177/1526602820952413
Abstrakt:	Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial ( ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.
Databáze:	MEDLINE
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