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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.
Eur J Vasc Endovasc Surg. 2007 Jan; 33(1):3-12.EJ

Abstract

OBJECTIVES

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).

DESIGN

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).

CONCLUSION

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.

Authors+Show Affiliations

Department of Vascular Surgery, Aker University Hospital, Norway. marthe@nylaende.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17055756

Citation

Nylaende, M, et al. "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." European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, vol. 33, no. 1, 2007, pp. 3-12.
Nylaende M, Abdelnoor M, Stranden E, et al. 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. Eur J Vasc Endovasc Surg. 2007;33(1):3-12.
Nylaende, M., Abdelnoor, M., Stranden, E., Morken, B., Sandbaek, G., Risum, Ø., Jørgensen, J. J., Lindahl, A. K., Arnesen, H., Seljeflot, I., & Kroese, A. J. (2007). 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. European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, 33(1), 3-12.
Nylaende M, et al. 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. Eur J Vasc Endovasc Surg. 2007;33(1):3-12. PubMed PMID: 17055756.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Nylaende,M, AU - Abdelnoor,M, AU - Stranden,E, AU - Morken,B, AU - Sandbaek,G, AU - Risum,Ø, AU - Jørgensen,J J, AU - Lindahl,A K, AU - Arnesen,H, AU - Seljeflot,I, AU - Kroese,A J, Y1 - 2006/10/20/ PY - 2006/06/14/received PY - 2006/08/27/accepted PY - 2006/10/24/pubmed PY - 2007/2/10/medline PY - 2006/10/24/entrez SP - 3 EP - 12 JF - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JO - Eur J Vasc Endovasc Surg VL - 33 IS - 1 N2 - OBJECTIVES: 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). DESIGN: 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). CONCLUSION: 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. SN - 1078-5884 UR - https://www.unboundmedicine.com/medline/citation/17055756/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1078-5884(06)00499-0 DB - PRIME DP - Unbound Medicine ER -