Coronary restenosis elimination with a sirolimus eluting stent - First European human experience with 6-month angiographic and intravascular ultrasonic follow-up

Aims Coronary stenting is limited by a 10%-60% restenosis rate due to neoin timal hyperplasia. Sirolimus is a macrocyclic lactone agent that interacts with cell-cycle regulating proteins and inhibits cell division between phas es GI and S1. The hypothesis tested in this study is that local delivery of sirolimus with an eluting stent can prevent restenosis. Methods and Results Fifteen patients were treated with 18 mm sirolimus elat ing BX VELOCITY (TM) stents. Quantitative angiography and three-dimensional quantitative intravascular ultrasound were performed at implantation and a t the 6 months follow-up. All stent implantations were successful. One pati ent died on day 1 of cerebral haemorrhage and one patient suffered a subacu te stent occlusion due to edge dissection (re-PTCA, CKMB 42). At 9 months n o further adverse events had occurred and all patients were angina free. Qu antitative coronary angiography revealed no change in minimal lumen diamete r and percent diameter stenosis and hence no in-lesion or in-stent restenos is. Quantitative intravascular ultrasound showed that intimal hyperplasia v olume and percent obstruction volume at follow-up were negligible at 5.3 mm (3) and 1.8%, respectively. No edge effect was observed in the segments pro ximal and distal to the stents. Conclusion Implantation of a sirolimus-eluting stent seems to effectively p revent intimal hyperplasia. (C) 2001 The European Society of Cardiology.