A RCT of non-surgical treatment for intermittent claudication in femoro-popliteal disease: 12-month results
Objective To compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined therapy (PTA + SEP) in the treatment of intermittent claudication (IC) due to femoro‐popliteal disease. Method Over a 6‐year period, 178 patients (108 men, median age 70 years) w...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2009
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/59563/ http://irep.iium.edu.my/59563/ http://irep.iium.edu.my/59563/ http://irep.iium.edu.my/59563/1/British%20Journal%20of%20Surgery%202009%2C96%28S1%29%2C%201-15.pdf |
| Summary: | Objective
To compare percutaneous transluminal angioplasty (PTA), a supervised exercise programme (SEP) and combined therapy (PTA + SEP) in the treatment of intermittent claudication (IC) due to femoro‐popliteal disease.
Method
Over a 6‐year period, 178 patients (108 men, median age 70 years) with angioplastiable femoro‐popliteal lesions were randomised to: PTA, SEP or PTA + SEP. Patients were assessed prior to and at 1, 3 6 and 12 months post‐treatment. ISCVS outcome criteria (ankle pressures, treadmill walking distances) and Quality of Life (QoL) questionnaires (SF‐36 and VascuQoL) were analysed.
Results
All groups were well matched at baseline. Thirty‐three patients withdrew. Intra‐group analysis: all groups demonstrated significant clinical and QoL improvements (Friedman test, p < 0·05); SEP (59 patients, 13 withdrew) − 69·6% of patients (n = 32) improved following treatment (19 mild, 10 moderate, 3 marked), 13% (n = 6) no improvement and 17·4% (n = 8) deteriorated; PTA (60 patients, 8 withdrew) − 71·2% of patients (n = 37) improved following treatment (16 mild, 16 moderate, 5 marked), 17·3% (n = 9) no improvement and 11·6% (n = 6) deteriorated; PTA + SEP (59 patients, 12 withdrew) − 85·2% of patients (n = 40) improved following treatment (18 mild, 20 moderate, 2 marked), 14·9% (n = 7) no improvement and 0% (n = 0) deteriorated. Inter‐group analysis: PTA + SEP produce a sustained improvement in clinical outcome measures than PTA or SEP alone, but there was no significant QoL advantage (Kruskal Wallis test, p > 0·05).
Conclusion
For patients with claudication, SEP should be the primary treatment and PTA should be supplemented by a SEP. |
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