Intensive vascular training in stage IIb of peripheral arterial occlusive disease. The additive effects of intravenous prostaglandin E1 or intravenous pentoxifylline during training.

Abstract

In a randomized open study, the combination of either prostaglandin El (PGE,) or pentoxifylline with controlled vascular training was compared with vascular training alone in patients with peripheral arterial occlusive disease in stage IIb. Forty-four patients were randomly assigned to treatment either of intensive vascular training alone (n=15) or in combination with either IV pentoxifylline (200 mg over 2 hours BID, n= 15) or PGE, (40 gg over 2 hours BID, n= 14). The basic therapy was a well-defined routine for vascular training, which was identical for all groups. The duration of therapy was 4 weeks. In all three test groups, there was a significant increase in the walking distance. There was a 119% increase in symptom-free walking distance in the exercise-only group. In comparison with exercise alone, the additional administration of pentoxifylline produced no greater effect; the increase was 105%. In contrast, administration of PGE, combined with exercise achieved a remarkable improvement of 604%. Between-group comparison revealed the significant superiority of treatment with PGE1 (P<.05). During the 1-year follow-up, there was a reduction in the walking performance in all groups, albeit of variable extent. In the exercise-only and the pentoxifylline groups, the maintained increase in walking distance was only 30% compared with baseline values before the beginning of therapy. In the PGE1 group, on the other hand, the maintained improvement was 149%. Nine of 14 patients were still in stage IIa of peripheral arterial occlusive disease 1 year after PGE1 therapy. (Circulation. 1994;90(818-822.) Key MethodsA total of 44 patients (33 men and 11 women) with stage lIb PAOD (age range, 42 to 81 years; mean, 60±9 years) were included in a randomized open trial. Mean body weight was 74±14 kg, and mean height was 168±9 cm. Mean blood pressure was 156/88±21/11 mm Hg, and heart rate averaged 75±9 beats per minute.Included in the study were patients with PAOD of the lower extremities who were stable and in stage IIb of the disease, according to Fontaine's classification.Further requirements were that the arterial occlusive disease had existed in this stage for more than 6 months and that it had been confirmed by intra-arterial digital subtraction angiography or conventional angiography that the stenosis or occlusion was of the upper leg or lower leg type. Maximum walking distance on the treadmill up a 5% slope at a walking pace of 3 km/h had to be at least 50 m and no more than 200 m. In addition, each patient's informed consent was required. Exclusion criteria were defined as pregnancy, decompensated heart failure, decompensated renal failure, hemodynamically relevant aortic or iliac arterial occlusion, presence of necrosis or pain at rest, respiratory insufficiency, joint problems affecting walking distance, myocardial infarction within the past 6 months, indispensable therapy with vasoactive drugs or drugs affecting peripheral perfusion, tendency to hypotonic collapse or orthostatic dysregulation (postural ...

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