Hemodilution in intermittent claudication:: Prospective randomized controlled clinical trial in patients with concomitant coronary heart disease (CHD)

Objective: Examination of efficacy and safety of hemodilution, with hydroxyethyl starch (HES) in intermittent claudication with concomitant coronary heart disease, Design and Setting: Prospective randomized controlled clinical trial at the departement of internal medicine of the Landeskrankenhaus Murzzuschlag (Austria), two intervention groups (group HR and group RH) with 10 patients each. Patients: 20 patients with peripheral arterial occlusive disease (PAOD) stage II b according to Fontaine (stable clinical picture for at least 6 months) and concomitant coronary heart disease. Interventions: In group HR infusion therapy for 7 days with 250 mi 10% HES 200/0.5 daily and after a wash out phase infusion therapy for 7 days with 250 mi Ringer's lactate daily, in group RH reverse order of the two infusion therapies. Primary endpoint: Pain-free walking distance (comparism of the effects of the infusion therapies within each group). Results: Elongation of pain-free walking distance (median) in group HR: 26.5% (HES) vs. 4.2% (Ringer's lactate) (p = 0.028: significant); elongation of pain-free walking distance (median) in group RH: 7.3% (Ringer's lactate) vs. 19.5% (HES) (p=0.203); no change in coronary heart disease during the observation period. Conclusions: Moderate hemodilution therapie with HES elongates pain-free walking distance in claudicants. It will be necessary to examine, to what extent this effect can be prolonged by subsequent medium- and long-term conservative treatment. Concomitant coronary heart disease (stable angina pectoris or status post myocardial infarction with good exercise tolerance and normal or slightly impaired left ventricular function) does not restrict the use of moderate HES hemodilution.