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The aim of this study was to evaluate the incidence and the cause of “edge restenosis” after implantation of high activity 41.1 μCi±1.2 μCi=1520 kBq±44 kBq, β-emitting ( 55 Co) stents. Proton bombarding in cyclotron has brought the radioactivity. Intravascular ultrasound (IVUS) investigation has been completed in 10 patients. The angiographies performed at 6 month revealed restenosis &gt;50 % in 5 cases (50 %). The analysis of edges (5 mm distally and proximally to the last stent struts) showed no significant changes in TVV (187.3±62.60 mm 3  and 176.9±53.5 mm 3 ) but PMV increase significantly (i.e. neointimal proliferation) from 61.9±31.2 mm 3  to 82.2±43.4 mm 3  (p&lt;0.04) and was the major contributor (from 66 %) to lumen volume loss (125.4±40.7 mm 3  and 94.7±22.2 mm 3 , p&lt;0.02). In conclusion, neither statistically significant positive nor negative remodelling at the “stent edges“, were present. Statistically significant increase in plaque+media volume (i.e. neointimal hyperplasia) and reduction in lumen volume were found. The cause of “edge restenosis” was especially (from 66 %) due to increase in plaque+media volume (i.e. neointimal hyperplasia). Probably, main reason for “edge effect”/neointimal hyperplasia was in this trial sharp fall-off in radiation at the edges of the stents.

The “Edge Effect” After Implantation of β-Emitting (55Co) Stents with High Initial Activity