Tolerance of Iloprost and results of treatment of chronic severe lower limb ischaemia in diabetic patients. A retrospective study of 64 consecutive cases.
BACKGROUND
The aim of this study was to assess the tolerance and report obtained results with a stable prostacyclin analogue (iloprost) in diabetic patients with severe forms of permanent lower limb ischaemia.


METHODS
Sixty-four consecutive unselected patients, in stage III and IV of Leriche and Fontaine, turned down for vascular surgery after angiography and treated with iloprost during 28 days, were enrolled in this study. Patients were followed-up clinically (ischemic pain, trophic change, walking distance) and with transcutaneous oxymetry (D28). Long-term assessment (6 and 12 months) was expressed as rate of death, major amputation and of live patients with viable limbs and walking. There was no manifestation of intolerance to iloprost. Were considered as responders patients offering a lack or significant decrease in pain, a reduction of trophic lesions and improvement or recovery of walking.


RESULTS
Response at two months is lasting: 29 responders (45.3%) and 35 non-responders (54.7%). At 6 months and one year, we observed that 8 (12.5%) and 15 (24.1%) patients respectively had died; 19 (29.6%) and 22 (34.3%) patients underwent major amputation, but 41 (64%) and 34 (53.1%) patients were still alive with their limb and conservative walking. In responder group, at 6 months, 28 (96.5%) patients were alive without amputation for only 13 (37.1%) among non-responders. At one year, 79.3% of the responders and 31.4% of the non-responders were alive without amputation. A total loss of walking, a segmental amputation and a previous amputation of opposite limb were more often noted in no responder group. But no predictive factor was referred to TcPO(2) in particular. Results ware similar in the group of 136 non diabetic patients treated during the same period (67.9% alive with limb at 6 months).


CONCLUSIONS
This retrospective study, despite its limitations, underlines the clinical particularities of critical ischaemia in diabetics and the good tolerance to iloprost. This point allowed patients, in non-surgical chronic critical ischaemia, to avoid being confined to bed and to access to benefits of a early physiotherapy, in association with local treatment. However, no predictive criterion of long-term results could be established, except initial clinical severity and clinical change one month after treatment.
Duthois
S
S
Service de Réadaptation vasculaire, Hôpital La Musse, Saint Sébastien de Morsent, France. sduthois@lamusse.com
Cailleux
N
N
Benosman
B
B
Lévesque
H
H
D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D003925:Diabetic Angiopathies / Q000188:drug therapy*; D005260:Female; D006801:Humans; D016285:Iloprost / Q000627:therapeutic use*; D007511:Ischemia / Q000188:drug therapy* / Q000601:surgery; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use
D014665:Vasodilator Agents; D016285:Iloprost