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 neointimal hyperplasia. Sirolimus is a macrocyclic lactone agent that interacts with cell-cycle regulating proteins and inhibits cell division between phases G1 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 eluting BX VELOCITY?? stents. Quantitative angiography and three-dimensional quantitative intravascular ultrasound were performed at implantation and at the 6 months follow-up. All stent implantations were successful. One patient died on day 2, of cerebral haemorrhage and one patient suffered a subacute stent occlusion due to edge dissection (re-PTCA, CKMB 42). At 9 months no further adverse events had occurred and all patients were angina free. Quantitative coronary angiography revealed no change in minimal lumen diameter and percent diameter stenosis and hence no in-lesion or in-stent restenosis. Quantitative intravascular ultrasound showed that intimal hyperplasia volume and percent obstruction volume at follow-up were negligible at 5.3 mm³ and 1.8%, respectively. No edge effect was observed in the segments proximal and distal to the stents. Conclusion: Implantation of a sirolimus-eluting stent seems to effectively prevent intimal hyperplasia.