Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease.
BACKGROUND
The aim was to compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined treatment (PTA plus SEP) for intermittent claudication due to femoropopliteal arterial disease.


METHODS
Consenting patients with femoropopliteal arterial lesions were randomized to one of three treatment arms: PTA, SEP, or PTA plus SEP. All patients received optimal medical treatment. Patients were assessed at baseline and 1, 3, 6 and 12 months after intervention. Clinical (ankle pressures, walking distances, symptoms) and quality-of-life (QoL) outcomes (Short Form 36, VascuQol) were analysed.


RESULTS
A total of 178 patients (108 men, median age 70 years) were included. All three treatment groups demonstrated significant clinical and QoL improvements. One year after PTA (60 patients, 8 withdrew), 37 patients (71 per cent) had improved (16 mild, 16 moderate, 5 marked), nine (17 per cent) showed no improvement and six (12 per cent) had deteriorated. After SEP (60 patients, 14 withdrew), 32 patients (70 per cent) had improved (19 mild, 10 moderate, 3 marked), six (13 per cent) showed no improvement and eight (17 per cent) had deteriorated. After PTA plus SEP (58 patients, 11 withdrew), 40 patients (85 per cent) had improved (18 mild, 20 moderate, 2 marked), seven (15 per cent) showed no improvement and none had deteriorated. On intergroup analysis, PTA and SEP alone were equally effective in improving clinical outcomes, although the effect was short-lived. PTA plus SEP produced a more sustained clinical improvement, but there was no significant QoL advantage.


CONCLUSIONS
For patients with intermittent claudication due to femoropopliteal disease, PTA, SEP, and PTA plus SEP were all equally effective in improving walking distance and QoL after 12 months.


BACKGROUND
NCT00798850 (http://www.clinicaltrials.gov).
Academic Vascular Surgical Unit, University of Hull, Hull, UK. fayyaz.mazari@hey.nhs.uk
F A K
FA
Mazari
J A
JA
Khan
D
D
Carradice
N
N
Samuel
M N A
MN
Abdul Rahman
S
S
Gulati
H L D
HL
Lee
T A
TA
Mehta
P T
PT
McCollum
I C
IC
Chetter
D000368:Aged; D000792:Angiography; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000628:therapy; D003131:Combined Modality Therapy; D015444:Exercise; D005081:Exercise Therapy; D005260:Female; D005263:Femoral Artery / Q000473:pathology*; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000473:pathology*; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D019233:Retreatment; D012307:Risk Factors; D016896:Treatment Outcome