Copyright © 2001 by the European Society of Cardiology.
Coronary restenosis elimination with a sirolimus eluting stent; First European human experience with 6-month angiographic and intravascular ultrasonic follow-up
Department of Interventional Cardiology, Thoraxcenter, Rotterdam, The Netherlands
revised July 13, 2001; accepted July 18, 2001
Abstract
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 18mm sirolimus eluting BX VELOCITYTM 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 5·3mm3and 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.
Key Words: Coronary artery disease, PTCA, stenting, restenosis prevention, sirolimus, eluting stent
f1 Correspondence: B. J. Rensing, MD, FESC, Department of Cardiology, St Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.
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