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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

The Effect of Variable Dose and Release Kinetics on Neointimal Hyperplasia Using a Novel Paclitaxel-Eluting Stent Platform

The Paclitaxel In-Stent Controlled Elution Study (PISCES)

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

^_* Erasmus Medical Center, Rotterdam, the Netherlands
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil
Amphia Ziekenhuis, Breda, the Netherlands
Catharina Ziekenhuis, Eindhoven, the Netherlands
^|| Medisch Centrum Rijnmond-Zuid, Rotterdam, the Netherlands
^¶ Christchurch Hospital, Christchurch, New Zealand
^# Academisch Ziekenhuis Middelheim, Antwerp, Belgium
^_** Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina
Hospital Miguel Perez Carreno, Caracas, Venezuela
Herzzentrum Bodensee, Kreuzlingen, Switzerland
Conor Medsystems, Menlo Park, California
^|||| Cardialysis, Rotterdam, the Netherlands.

Manuscript received November 30, 2004; revised manuscript received March 17, 2005, accepted March 29, 2005.

^_* Reprint requests and correspondence: Dr. Patrick W. Serruys, Erasmus Medical Center, Thoraxcenter, Bd-406, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. (Email: p.w.j.c.serruys{at}erasmusmc.nl).

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.

Abbreviations and Acronyms   DES = drug-eluting stent(s)   IVUS = intravascular ultrasound   LV = lumen volume   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimal luminal diameter   PISCES = Paclitaxel In-Stent Controlled Elution Study   QCA = quantitative coronary angiography   SV = stroke volume   TLR = target lesion revascularization   TVR = target vessel revascularization

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