Author + information
- Received August 7, 2009
- Revision received November 30, 2009
- Accepted December 13, 2009
- Published online April 1, 2010.
- Eberhard Grube, MD⁎,⁎ (, )
- Joachim Schofer, MD†,
- Karl E. Hauptmann, MD‡,
- Georg Nickenig, MD§,
- Nicholas Curzen, MD∥,
- Dominic J. Allocco, MD¶ and
- Keith D. Dawkins, MD¶
- ↵⁎Reprint requests and correspondence:
Dr. Eberhard Grube, Int'l Heart Center Rhein-Ruhr, Klara-Klopp-Weg 1, Essen 45138, Germany
Objectives The JACTAX HD trial (“JACTAX” Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions.
Background The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 μm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 μg each of polymer and paclitaxel per 16-mm stent).
Methods In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%).
Results The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 ± 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 ± 11.2%.
Conclusions The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. (“JACTAX” Trial Drug Eluting Stent Trial; NCT00754728)
This work was supported by Boston Scientific Corporation, Natick, Massachusetts. Dr. Grube has served on the Speakers' Bureau for Boston Scientific and has been a member of the Scientific Advisory Board. Drs. Allocco and Dawkins are full-time employees and stockholders of Boston Scientific.
- Received August 7, 2009.
- Revision received November 30, 2009.
- Accepted December 13, 2009.
- American College of Cardiology Foundation