The Oslo balloon angioplasty versus conservative treatment study (OBACT)--the 2-years results of a single centre, prospective, randomised study in patients with intermittent claudication.
OBJECTIVE
To compare the effect of optimal medical treatment only (OMT) with OMT combined with percutaneous transluminal angioplasty (OMT+PTA) in patients with intermittent claudication (IC).


METHODS
A single centre prospective, randomised study. Quality of life (QoL) was the primary outcome measure. Secondary measures were ankle-brachial-index (ABI), treadmill walking distances and mortality.


METHODS
From a total of 434 patients considered for inclusion into the trial, only 56 patients with disabling IC fulfilled the inclusion criteria. The patients were randomised into treatment groups consisting of 28 patients each and followed for 2 years. ABI and treadmill walking distances were measured in addition to the visual analogue scale (VAS) for pain evaluation, and QoL assessment using the Short Form (SF-36 and Claudication Scale (CLAU-S).


RESULTS
The demographic data in the 2 groups were almost identical. After 2 years of follow-up the ABI, the treadmill walking distances and the VAS were significant improved in the group treated with OMT+PTA, compared to the group treated with OMT only (p<0.01 for all). Furthermore, some variables from the QoL assessment also showed a significant improvement in favour of the OMT+PTA group (p<0.05 for all).


CONCLUSIONS
The advantage of conducting a single centre study and adhering to very strict inclusion criteria was illustrated by the homogenous demographic data of the two groups. This partly outweighed the disadvantage of having included a relatively small number of patients. Early intervention with PTA in addition to OMT seems to have a generally more positive effect compared to OMT only, on haemodynamic, functional as well as QoL aspects during the first 2 years in patients with IC.
Nylaende
M
M
Department of Vascular Surgery, Aker University Hospital, Norway. marthe@nylaende.com
Abdelnoor
M
M
Stranden
E
E
Morken
B
B
Sandbaek
G
G
Risum
Ø
Ø
Jørgensen
J J
JJ
Lindahl
A K
AK
Arnesen
H
H
Seljeflot
I
I
Kroese
A J
AJ
D000368:Aged; D000800:Angioplasty, Balloon; D000842:Ankle / Q000098:blood supply; D001794:Blood Pressure; D001916:Brachial Artery / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010147:Pain Measurement; D010349:Patient Compliance; D018579:Patient Selection; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking