Peripheral Vascular Restenosis: A Retrospective Study on the Use of Drug-Eluting Balloons in Native Arteries, Vein Grafts and Dialysis Accesses.
OBJECTIVE
The objective of this study is to analyze outcomes of the first experiences with drug-eluting balloons in native arteries, vein grafts, and vascular accesses. The study is also a pilot for our future prospective, randomized, and controlled studies regarding the use of drug-eluting balloons in the treatment of the stenosis in bypass vein graft and dialysis access.


METHODS
A total of 93 consecutive patients were retrospectively analyzed and in the end 81 were included in the study. Inclusion criteria included at least one previous percutaneous angioplasty to the same lesion. Patients were divided into three groups according to the anatomical site of the lesion: native lower limb artery, vein bypass graft, or vascular access. Time from the previous percutaneous angioplasty to the drug-eluting balloon was compared to the time from the drug-eluting balloon to endpoint in the same patient. Endpoints included any new revascularization of the target lesion, major amputation, or new vascular access.


RESULTS
The median time from the drug-eluting balloon to endpoint was significantly longer than the median time from the preceding percutaneous angioplasty to drug-eluting balloon in all three groups. This difference was clearest in native arteries and vein grafts, whereas the difference was smaller from the beginning and disappeared over time in the vascular access group. No significant differences were seen between the groups with regard to smoking, antiplatelet regime, diabetes, Rutherford classification, or sex.


CONCLUSIONS
Although the setup of this study has several limitations, the results suggest that there could be benefit from drug-eluting balloons in peripheral lesions. Very little data have been published on the use of drug-eluting balloons in vein grafts and vascular accesses, and randomized and controlled prospective studies are needed to further investigate this field.
1 Department of Vascular Surgery, Helsinki University Hospital, Helsinki, Finland.
P
P
Björkman
2 Department of Radiology, Helsinki University Hospital, Helsinki, Finland.
E
E
Peltola
1 Department of Vascular Surgery, Helsinki University Hospital, Helsinki, Finland.
A
A
Albäck
1 Department of Vascular Surgery, Helsinki University Hospital, Helsinki, Finland.
M
M
Venermo
D000792:Angiography / Q000379:methods; D000800:Angioplasty, Balloon / Q000379:methods*; D015331:Cohort Studies; D003251:Constriction, Pathologic / Q000000981:diagnostic imaging / Q000628:therapy; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000379:methods; D005260:Female; D005268:Femoral Vein / Q000601:surgery / Q000637:transplantation*; D006085:Graft Survival; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D010865:Pilot Projects; D011150:Popliteal Artery / Q000601:surgery / Q000637:transplantation*; D012189:Retrospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome; D062666:Vascular Access Devices / Q000009:adverse effects*; D014654:Vascular Patency / Q000502:physiology
Peripheral arterial disease; drug-eluting balloon; patency; percutaneous angioplasty; restenosis; revascularization; vascular access; vein graft