ORIGINAL ARTICLES   

International Angiology 1999 December;18(4):251-5

Copyright © 2000 EDIZIONI MINERVA MEDICA

lingua: Inglese

Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study

Zdanowski Z. ¹, Albrechtsson U. ², Lundin A. ², Jonung T. ¹, Ribbe E. ¹, Thörne J. ¹, Norgren L. ¹

From the Departments of 1 Surgery and 2 Diagnostic Radiology, Lund University, Lund, Sweden

Background. To inves­ti­gate the-one year out­come of PTA and stent­ing and PTA alone for femor­o­pop­li­teal occlu­sions. Design: Randomized pros­pec­tive study
Meth­ods. 32 ­patients with femor­o­pop­li­teal occlu­sions were ran­dom­ized into two treat­ment ­groups: PTA and Strecker-stent (n=15) and PTA alone (n=17). The ­median age of the ­patients was 71 years. All ­patients had chron­ic limb ischae­mia, 66% had tis­sue loss, 19% had rest pain and 15% had dis­abling claud­i­ca­tion. The ­median ABPI was 0.45. The occlu­sion was con­fined to the super­fi­cial femo­ral ­artery in 30 cases and to the pop­li­teal ­artery in 2 cases. The ­median ­length of the occlu­sions was 7.3 cm. Aspirin (ASA), 160 mg daily, was admin­is­trat­ed post­op­er­a­tive­ly but no anti­co­ag­u­la­tion was used. The fol­low-up includ­ed: clin­i­cal exam­ina­tion, meas­ure­ment of ABPI and con­trol angio­gra­phy at 12 ­months or ear­li­er when nec­es­sary (20 ­patients).
Results. There was no mor­tal­ity or limb loss as a con­se­quence of the treat­ment. There were six (16%) imme­di­ate major com­pli­ca­tions in five ­patients. In the PTA group, one ­patient had a myo­car­dial infarc­tion and three ­patients need­ed arter­i­ogr­a­phy due to bleed­ing. In the stent group, one ­patient ­required arter­i­ogr­a­phy and embo­lec­to­my. The one-year mor­tal­ity was 6% and there were no ampu­ta­tions. Four ­patients (two in each group) were oper­at­ed on with a femor­o­dis­tal bypass. The rate of clin­i­cal improve­ment was 71% after PTA and stent and 60% after PTA alone (p=0.17). An ­increased ABPI (>0.10) was shown in 50% of the stent group and 61% in the PTA group (p=0.17). Angiographic re-oc­clu­sions were seen in 33% and 75% in the stent and PTA ­groups respec­tive­ly (p=0.17), while the rate of resten­o­sis was sig­nif­i­cant­ly high­er in the stent group (50% vs 25%) (p=0.033).
Conclusions. Stenting fol­low­ing PTA for femor­o­pop­li­teal occlu­sions does not sig­nif­i­cant­ly ­improve nei­ther the clin­i­cal state nor the clin­i­cal/angio­graph­ic paten­cy. The ­results do not jus­ti­fy any rou­tine place­ment of stent fol­low­ing PTA in the suc­cess­ful­ly rec­a­nal­ized femo­ro-pop­li­teal arter­ies. The low rate of accep­tance of a fol­low-up angio­gra­phy indi­cates that this kind of study ­should pref­er­ably use ­duplex scan­ning ­instead of angio­gra­phy for fol­low-up.