Document Detail

Low-molecular-weight heparin for prevention of restenosis after femoropopliteal percutaneous transluminal angioplasty: a randomized controlled trial.
MedLine Citation:
PMID:  17145426     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Restenosis after angioplasty is essentially due to intimal hyperplasia. Low-molecular-weight heparins (LMWHs) have experimentally been shown to have antiproliferative effects in addition to their antithrombotic properties. Their potential in reducing restenosis remains to be established. Therefore, we wanted to test the hypothesis that LMWH plus aspirin is more effective than aspirin alone in reducing the incidence of restenosis/reocclusion in patients undergoing percutaneous transluminal angioplasty (PTA) of femoropopliteal arteries. Further, different effects of LMWH in patients treated for critical limb ischemia (CLI) or claudication only should be investigated.
METHODS: After successful PTA, 275 patients with symptomatic peripheral arterial disease (claudication or critical limb ischemia) and femoropopliteal obstructions were randomized to receive either 2500 IU of dalteparin subcutaneously for 3 months plus 100 mg of aspirin daily (n = 137), or 100 mg aspirin daily alone (n = 138). The primary end point was restenosis or reocclusion documented by duplex ultrasonography imaging at 12 months.
RESULTS: Restenosis/reocclusion occurred in 58 patients (44%) in the dalteparin group and in 62 patients (50%) in the control group (P = .30). In a subgroup analysis according to the severity of peripheral arterial disease, we found that in patients treated for claudication, restenosis/reocclusion developed in 43 (43%) in the dalteparin group, and in 35 (41%) in the control group (P = .70); in patients treated for CLI, restenosis/reocclusion was significantly lower in the dalteparin group (15, 45%) than in the control group (27, 72%; P = .01). No major bleeding events occurred in either group.
CONCLUSIONS: Treatment with 2500 IU dalteparin subcutaneously given for 3 months after femoropopliteal PTA failed to reduce restenosis/reocclusion at 12 months. However, dalteparin may be beneficial in the subgroup of patients with CLI at 12 months follow-up.
Renate Koppensteiner; Silviana Spring; Béatrice R Amann-Vesti; Thomas Meier; Thomas Pfammatter; Valentin Rousson; Martin Banyai; Bernd van der Loo
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of vascular surgery     Volume:  44     ISSN:  0741-5214     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2006-12-05     Completed Date:  2007-01-19     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1247-53     Citation Subset:  IM    
Clinic of Angiology, Department of Internal Medicine, Zurich, Switzerland.
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MeSH Terms
Angioplasty, Balloon / adverse effects*
Arterial Occlusive Diseases / prevention & control*,  therapy,  ultrasonography
Aspirin / therapeutic use
Dalteparin / therapeutic use
Drug Therapy, Combination
Femoral Artery / ultrasonography*
Fibrinolytic Agents / adverse effects,  therapeutic use*
Follow-Up Studies
Heparin, Low-Molecular-Weight / adverse effects,  therapeutic use*
Intermittent Claudication / prevention & control,  therapy
Ischemia / prevention & control,  therapy
Lower Extremity / blood supply
Peripheral Vascular Diseases / prevention & control*,  therapy,  ultrasonography
Platelet Aggregation Inhibitors / therapeutic use
Popliteal Artery / ultrasonography*
Proportional Hazards Models
Prospective Studies
Recurrence / prevention & control
Research Design
Severity of Illness Index
Time Factors
Treatment Outcome
Vascular Patency
Reg. No./Substance:
0/Dalteparin; 0/Fibrinolytic Agents; 0/Heparin, Low-Molecular-Weight; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin

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