Laurora G, Cesarone M R, Belcaro G, Incandela L, De Sanctis M T, Fascetti E, D'Archivio C
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Minerva Cardioangiol. 1998 Oct;46(10 Suppl 1):17-20.
Intra-arterial infusion of PGE1 alpha-ciclodestrina was achieved by intrafemoral catheter in critical limb ischemia.
The acute infusion of 10 micrograms in 20 minutes, in 50 ml of saline was followed by chronic infusion 20 micrograms/die of PGE1 alpha-ciclodestrina for 5 days. Three male patients (age 65 +/- 12) with severe critical ischemia and rest pain with initial, localised (> 0.5 cm in diameter) necrosis were treated. There was no possibility of revascularisation in these patient.
No side effects due to the intra-arterial infusion were observed. After the acute infusion skin flux (measured with laser Doppler at the dorsum of the foot) was increased on average 15.2 times (P < 0.01). The increase in flux was still present 10 days after the initial intra-arterial infusion. Pain was greatly decreased or disappeared in the three following 3 weeks.
In conclusion, even on the basis of limited clinical data, intra-arterial infusion acutely improves skin perfusion in critical limb ischemia. It could be considered a fast acting treatment in critical ischemia and also a rapid method to evaluate the possibility of improving distal perfusion with PGE1 alpha-ciclodestrina (i.e. patients not responding to intra-arterial infusion could be considered for amputation).