Quality of life after balloon angioplasty versus stent implantation in the superficial femoral artery: findings from a randomized controlled trial.
OBJECTIVE
To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL).


METHODS
One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention.


RESULTS
QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting.


CONCLUSIONS
Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.
Sabeti
Schila
S
Department of Angiology, Medical School, Medical University Vienna, and Department of Internal Medicine II, Vienna General Hospital, Austria. schila.sabeti@meduniwien.ac.at
Czerwenka-Wenkstetten
Alfa
A
Dick
Petra
P
Schlager
Oliver
O
Amighi
Jasmin
J
Mlekusch
Irene
I
Mlekusch
Wolfgang
W
Loewe
Christian
C
Cejna
Manfred
M
Lammer
Johannes
J
Minar
Erich
E
Schillinger
Martin
M
D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D002908:Chronic Disease; D005260:Female; D005263:Femoral Artery; D006305:Health Status Indicators; D006801:Humans; D007511:Ischemia / Q000209:etiology* / Q000503:physiopathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D020127:Recovery of Function; D012008:Recurrence; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000295:instrumentation*; D016138:Walking
D000497:Alloys; C013616:nitinol