Are there predictors for the outcome of a PGE1 treatment in peripheral arterial disease with critical limb ischaemia?

Abstract

Background: In a multivariate retrospective analysis was conducted to examine whether and to what extent PGE1 is therapeutically effective and whether there are predictors of response. Patients and methods: The examination included 767 patients (448 women, 319 men) of a mean age of 71.2 years and with peripheral arterial disease (PAD) having existed for 44.7 months on the average. They suffered from critical limb ischaemia (Fontaine’s stages III/IV) and showed average tcpO2 values at the instep of 2 mmHg (0 to 15) and average systolic malleolar artery pressures of 18 mmHg (0 to 35 mmHg). Between 1989 and 2001, the patients had received treatments in hospital with i.v. PGE1 doses (2 x 20 mug or 1 x 60 mug/day) for an average of 34.2 days (mean of responder- and non-responder group). Patients were called responders when pain had markedly decreased or disappeared, necroses had been reduced or healed completely, and vascular reconstruction, PTA or amputations were not necessary. Results: The clinical analysis showed 82.4% of the patients to be responders and 17.6% to be non-responders. It was demonstrated that the outcome of the therapy was not dependent on the supine or sitting tcpO2, the malleolar artery pressure, the patient’s age or sex, the duration of PAD, the number or kind of concomitant diseases, the patient’s general condition, the localization and number of vascular occlusions, the kind of prior therapy, or the number of previous amputations, although differences in some of the parameters, while clinically irrelevant, were found to be statistically significant. They are not predictors of the outcome of a PGE1 therapy. Conclusions: Even in extremely bad haemodynamic situations at the beginning of a therapy (malleolar artery pressures from 0 to 35 mmHg, tcpO2 0 to 15 mmHg, multilevel occlusive disease, multiple previous operations and concomitant diseases), PGE1 therapies of more than 20 days – on the average 35.6 days (mean of responder group) – duration allow clinically relevant positive results to be achieved.