A Novel Paclitaxel-Eluting Stent With an Ultrathin Abluminal Biodegradable Polymer 9-Month Outcomes With the JACTAX HD Stent

作者：Grube Eberhard^*; Schofer Joachim; Hauptmann Karl E; Nickenig Georg; Curzen Nicholas; Allocco Dominic J; Dawkins Keith D

来源：JACC: Cardiovascular Interventions , 2010, 3(4): 431-438.

DOI：10.1016/j.jcin.2009.12.015

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 Liberte (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 mu m) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 mu g 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 Liberte-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 Liberte (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.

• 出版日期2010-4