Author + information
- Received November 30, 2004
- Revision received March 17, 2005
- Accepted March 29, 2005
- Published online July 19, 2005.
- Patrick W. Serruys, MD, PhD, FACC⁎,⁎ (, )
- Georgios Sianos, MD, PhD⁎,
- Alexandre Abizaid, MD†,
- Jiro Aoki, MD⁎,
- Peter den Heijer, MD, PhD‡,
- Hans Bonnier, MD, PhD§,
- Pieter Smits, MD, PhD∥,
- Dougal McClean, MD¶,
- Stefan Verheye, MD, PhD#,
- Jorge Belardi, MD⁎⁎,
- Jose Condado, MD††,
- Michel Pieper, MD‡‡,
- Louise Gambone, BA§§,
- Marco Bressers, MSc∥∥,
- Janette Symons∥∥,
- Eduardo Sousa, MD† and
- Frank Litvack, MD, FACC§§
- ↵⁎Reprint requests and correspondence:
Dr. Patrick W. Serruys, Erasmus Medical Center, Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
Objectives The aim of this study was to evaluate the effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia.
Background Conventional paclitaxel-eluting stents use a durable polymer coating as a vehicle for drug delivery. The Conor stent (Conor Medsystems, Menlo Park, California) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmacokinetics.
Methods Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent (n = 53) or one of six different release formulations that varied in dose (10 or 30 μg) and elution release kinetics (first order, zero order), direction (abluminal, luminal), and duration (5, 10, and 30 days). End points at six months (bare stent group) and at four months (eluting stent groups) were angiographic late loss and neointimal tissue volume by intravascular ultrasound and the rate of major adverse cardiac events (MACE).
Results The lowest in-stent late loss (0.38 mm, p <0.01, and 0.30 mm, p <0.01) and volume obstruction (8%, p <0.01, and 5%, p <0.01) were observed with the 10-μg and 30-μg doses in the 30-day release groups respectively, whereas the highest in-stent late loss (0.88 mm), volume obstruction (26%), and restenosis rate (11.6%) were observed in the bare stent group. The overall MACE rate of the eluting stent group was 8.6%: death 0.5%, myocardial infarction 2.7%, and target lesion revascularization (TLR) 5.3%. Sub-acute thrombosis was 0.5%. The TLR rates in the two 30-day release groups were 0% and 3.4%.
Conclusions This novel eluting stent platform, using an erodable polymer with complete elution of low doses of paclitaxel, is safe. The inhibition of the in-stent neointimal hyperplasia was best in the long release groups.
This study received support from Conor Medsystems. Dr. Litvack and Ms. Gambone are employees of Conor Medsystems.
- Received November 30, 2004.
- Revision received March 17, 2005.
- Accepted March 29, 2005.
- American College of Cardiology Foundation