[Cardiovascular morbidity/mortality modified by the use of FGE1 alpha-cyclodextran and calcium heparin in patients with severe vascular diseases].

Background: Morbidity and mortality were evaluated in three groups of vascular patients: one group was treated with PGE1 alpha-ciclodestrina according to the short term protocol; the second group was treated with PGE1 alpha-ciclodestrina and subcutaneous calcium heparin (SCH; 0.5 ml once daily, in the evening) while a third group was a historical reference group.

Methods: All included patients had a follow up of at least 12 months. The historical reference group had been managed without PGE1 alpha-ciclodestrina or SCH while in the two PGE1 alpha-ciclodestrina groups included patients who had been treated with at least four PGE1 alpha-ciclodestrina short-term treatment cycles per year. The 3 groups were comparable for sex and age distribution. In the PGE1 alpha-ciclodestrina group 142 patients (64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia). The historical reference group included 157 patients (65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia). The group treated with PGE1 alpha-ciclodestrina and SCH included 74 patients (27 with claudication and 47 with critical ischemia).

Results: In claudicants yearly cardiovascular morbidity was reduced from 15.5% in the reference group to 10.2% in patients treated with PGE1 alpha-ciclodestrina and to 7.9% in those treated with PGE1 alpha-ciclodestrina and SCH. Mortality decreased from 11.3% in the reference group to 6% in the PGE1 alpha-ciclodestrina group and to 5.1% in the PGE1 alpha-ciclodestrina + SCH group. In patients with critical limb ischemia morbidity decreased from 28.6% in the reference group to 23.2% in PGE1 alpha-ciclodestrina-group and to 19.4% in the PGE1 alpha-ciclodestrina + SCH group. Mortality also decreased from 16% (reference group) to 13% in the PGE1 alpha-ciclodestrinagroup, to 10.3% in the PGE1 alpha-ciclodestrina + SCH group.

Conclusion: Cyclic treatment with PGE1 alpha-ciclodestrina produces an important decrease in cardiovascular morbidity and mortality which could be further reduced by the chronic use of subcutaneous calcium heparin.