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Dr. Horst Sievert,
Discussant Report: The investigators made assumptions about thromboembolic complications of elective peripheral interventions based on the published results. They developed a concept to prevent these complications with abciximab (ReoPro) and conducted a randomized multicenter trial.
This trial failed its primary combined endpoint death, amputation, re-intervention or occlusion at 30 days. There was a significant reduction of intraprocedural peripheral embolism and a significant reduction in 6 months target vessel occlusion but also a five-fold increase of severe bleeding complications.
This trial was very well designed and carefully conducted. Although the primary endpoint failed, there was some improvement with ReoPro, which was not only statistically significant but also clinically relevant. However, bleeding complications are a major cause of morbidity and mortality of peripheral interventions. Therefore the observed increase in bleeding complications is not acceptable. It is unclear whether the bleeding complications could be reduced by modified access site management. According to these results, ReoPro seems not to be indicated in elective peripheral interventions. It may be that sub-group analyses (diabetes?) will give more insights.
Reopro and peripheral arterial intervention to improve clinical outcome in patients with peripheral arterial disease (RIO-Trial).
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