BACKGROUND AND AIM: The aim of this study was to compare the effects of a pharmacological and a surgical vasodilatatory therapy in the treatment of chronic arterial diseases of the lower limbs. METHODS AND RESULTS: After giving their informed consent, 40 patients were randomised to receive a slow (approximately 2-hour) infusion of 40 microg of prostaglandin E1 twice daily for 28 days (group A), and 46 were randomised to undergo lumbar sympathectomy, including the second and third ganglion. Twenty-four (60%) of the patients in group A experienced complete remission, seven (17.5%) were partial responders, and nine (22.5%) failed to respond. Of the 46 patients in group B, 29 (63%) experienced complete remission, seven (15.2%) were partial responders, and 10 (21.7%) failed to respond. CONCLUSIONS: Broadly similar results were obtained with the two types of treatment, both of which are indicated mainly in Fontaine stages IIB and III (non-advanced), particularly when revascularising therapy is impossible or excessively risky. The two strategies can be advantageously combined with direct revascularisation surgery and may therefore constitute a first-line approach favouring subsequent therapy.
RCT Entities:
BACKGROUND AND AIM: The aim of this study was to compare the effects of a pharmacological and a surgical vasodilatatory therapy in the treatment of chronic arterial diseases of the lower limbs. METHODS AND RESULTS: After giving their informed consent, 40 patients were randomised to receive a slow (approximately 2-hour) infusion of 40 microg of prostaglandin E1 twice daily for 28 days (group A), and 46 were randomised to undergo lumbar sympathectomy, including the second and third ganglion. Twenty-four (60%) of the patients in group A experienced complete remission, seven (17.5%) were partial responders, and nine (22.5%) failed to respond. Of the 46 patients in group B, 29 (63%) experienced complete remission, seven (15.2%) were partial responders, and 10 (21.7%) failed to respond. CONCLUSIONS: Broadly similar results were obtained with the two types of treatment, both of which are indicated mainly in Fontaine stages IIB and III (non-advanced), particularly when revascularising therapy is impossible or excessively risky. The two strategies can be advantageously combined with direct revascularisation surgery and may therefore constitute a first-line approach favouring subsequent therapy.