Boston Scientific's Jactax DES Shows Promise in First-Human-Use Study

April 20, 2010—Eberhard Grube, MD, et al have published 9-month outcomes of the JACTAX drug-eluting stent trial in the Journal of the American College of Cardiology: Cardiovascular Interventions (2010;3:431–438). The trial is evaluating the safety and clinical performance of the Jactax HD (Boston Scientific Corporation, Natick, MA) paclitaxel-eluting stent in de novo coronary lesions. The Jactax stent consists of a precrimped, bare-metal Liberté stent (Boston Scientific Corporation) that is coated on its abluminal aspect with an ultrathin (< 1 µm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel, which is applied as discrete microdots (nominal totals of 9.2 µg each of polymer and paclitaxel per 16-mm stent).

According to the investigators, this is a prospective, single-arm, multicenter, first-human-use study (n = 103). The primary endpoint of 9-month major adverse cardiac events (MACE; including cardiac death, myocardial infarction, and ischemia-related target vessel revascularization) was compared with an objective performance criterion of 17% (11% MACE rate based on TAXUS ATLAS [Taxus Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions] trial results plus a 6% prespecified noninferiority margin).

The investigators reported that the composite primary endpoint occurred in 7.8% of Jactax HD patients, with an upper one-sided 95% confidence limit of 13.6%, thus meeting the prespecified 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%.

The investigators concluded that in terms of MACE, in-stent late loss, restenosis, and net volume obstruction, the Jactax HD stent with an abluminal biodegradable polymer coating had results at 9 months that were comparable to those observed with the Liberté stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new paclitaxel-eluting stent design, which might allow for more rapid endothelialization and improved vessel healing, the investigators advised.