Potential use of a low-molecular-weight heparin to prevent restenosis in patients with extensive wall damage following peripheral angioplasty

The long-term outcome of primary successful percutaneous transluminal angio plasty (PTA) for patients with peripheral occlusive arterial disease (POAD) is frequently compromised by the development of restenosis, especially whe n extensive dissections result from the angioplastic procedure. Unfortunate ly, prevention of the occlusive process by means of drugs such as antithrom botics, anticoagulants, thrombolytics, corticosteroids, lipid reducers, or cytostatics has not been demonstrated convincingly, The authors sought to c larify whether such patients could benefit from the postsurgical administra tion of low-molecular-weight heparin. A total of 172 POAD patients with extensive dissections after PTA in the pe lvic or upper leg regions were randomized for 7-day post-PTA intravenous tr eatment with either full heparinization or nadroparin calcium followed by a djunctive oral aspirin for 6 months. The primary outcome measure was the de gree of stenosis (normal findings; stenosis < 50%, > 50%, > 80%, occlusion) before and after angioplasty, as well as 3 weeks and 3 and 6 months after dilation; secondary efficacy criteria included changes in the Fontaine stag e and in the crurobrachial ratio. No significant treatment-related differences were found at the 3 post-PTA f ollow-up examinations with regard to the degree of stenosis. This was also the case for the subgroup of patients (n = 62) who had undergone angioplast y in the pelvic region. By contrast, when angioplasty was performed in the superficial femoral artery (n = 110), the degree of restenosis was signific antly lower (p < 0.01) among patients receiving nadroparin calcium compared to those given heparin at week 3, month 3, and month 6. No intergroup diff erences emerged for secondary outcome measures in the long term or for safe ty parameters. These preliminary results indicate that patients with extens ive dissections after PTA treatment for POAD in the upper leg region might benefit from a reduction in the rate of restenosis by administration of 7-d ay weight-adjusted nadroparin calcium.