Percutaneous transluminal angioplasty versus turbostatic carbon-coated stents in infrapopliteal arteries: InPeria II trial.
OBJECTIVE
To determine the clinical outcome and the success of stent application for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia (CLI).


METHODS
In this ethics board-approved randomized prospective study, PTA or stent application was performed on 131 lesions in 88 patients with CLI. The primary end points were clinical improvement after endovascular treatment and limb salvage rate. Secondary end points were defined by the minimal lumen diameter (MLD) before and after the revascularization procedure, percentage of residual diameter stenosis (DS), binary restenosis rate (>50% DS and >70% DS), and incidence of target lesion revascularization at 9-month follow-up.


RESULTS
At 3 months, the clinical status in the PTA group was less improved than that in the stent group (P = .008). At 9 months, there had been five minor and two major amputations in the PTA group and five major and five minor amputations in the stent group. MLD was significantly larger and the percentage of DS was significantly less in the stent group at completion angiography. At 9 months, the angiographic control showed better trends for the stent group in comparison to the PTA group despite that no significant differences were detected (MLD, 1.19 mm ± 0.92 vs 1.02 mm ± 1.02; DS, 38.68% ± 25.47 vs 43.31% ± 28.37).


CONCLUSIONS
Infrapopliteal stent application is an effective treatment modality in CLI. The PTA and stent groups were essentially equal at 3 and 9 months except for the difference in clinical improvement in the stent group at 3 months.
Department of Radiology, General Hospital Hietzing, Wolkersbergenstr. 1, 1130 Vienna, Austria. Thomas.Rand@wienkav.at
Thomas
T
Rand
Johannes
J
Lammer
Claudio
C
Rabbia
Manuel
M
Maynar
Tobias
T
Zander
Thomas
T
Jahnke
Stefan
S
Müller-Hülsbeck
Dierk
D
Scheinert
Hannu I
HI
Manninen
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods*; D002244:Carbon; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D005060:Europe; D005260:Female; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D002244:Carbon