Thrombin and platelet inhibition with low-dose calcium-heparin in comparison with ASA in patients with peripheral arterial occlusive disease at Leriche-Fontaine IIb class.
Sixty patients with a mean age of 64 years (range 57-77 years), 55 males and 5 females, with peripheral arterial occlusive disease (PAOD) at Leriche-Fontaine IIb class were randomly allocated to receive either subcutaneous calcium-heparin (12,500 IU once daily) or oral acetylsalicylic acid (ASA) (300 mg twice daily), each given for 3 months, followed by a 6-month follow-up period during which no treatment was given. The following parameters were evaluated before randomization, after 1 and 3 months of therapy and after 1, 3 and 6 months of follow-up: pain-free walking distance (PWD), maximum walking distance (WDmax), systolic and diastolic blood pressure, posterior tibial arterial pressure and ankle/arm index at rest and after exercise (treadmill), transcutaneous gas analysis at rest (TcPO2). Under both treatments a statistically significant increase (p < 0.01) in PWD/WDmax was observed after 3 months of therapy. Calcium-heparin was slightly but significantly more effective than ASA in prolonging WDmax (p < 0.05) after 3 months of therapy. Both treatment groups maintained the clinical improvement after 6 months of follow-up without any difference between each-other. Both treatments resulted in a statistically significant increase in TcPO2 and decrease in plasma fibrinogen but under calcium-heparin treatment these modifications were doubled in comparison with ASA (p < 0.01 and p < 0.05, respectively for TcPO2 and fibrinogen). The sustained effects on these parameters after 6 months of follow-up could suggest a more direct and multifactorial activity of calcium-heparin on microcirculation.(ABSTRACT TRUNCATED AT 250 WORDS)
Allegra
C
C
Department of Angiology-Day Hospital, Hospital S. Giovanni, Roma, Italy.
Pollari
G
G
Carioti
B
B
Sardina
M
M
D000284:Administration, Oral; D000368:Aged; D001157:Arterial Occlusive Diseases / Q000145:classification / Q000628:therapy*; D001241:Aspirin / Q000494:pharmacology*; D001792:Blood Platelets / Q000187:drug effects*; D005080:Exercise Test; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D006493:Heparin / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D007279:Injections, Subcutaneous; D007383:Intermittent Claudication / Q000628:therapy; D008297:Male; D008875:Middle Aged; D015539:Platelet Activation / Q000187:drug effects; D013917:Thrombin / Q000187:drug effects*
D005343:Fibrinolytic Agents; C006871:calcium heparin; D006493:Heparin; D013917:Thrombin; D001241:Aspirin