A novel paclitaxe-eluting stent with an ultrathin abluminal biodegradeable polymer 9-month outcomes with the JACTAX HD stent
A novel paclitaxe-eluting stent with an ultrathin abluminal biodegradeable polymer 9-month outcomes with the JACTAX HD stent
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 ?m) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 ?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 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)
biodegradable polymer, coronary restenosis, drug-eluting stent
431-438
Grube, E.
abec52aa-1d3d-4a30-8fca-061cec6744d1
Schofer, J.
dcb1b4d3-8f78-4328-8212-5dd0393ad869
Hauptmann, K.E.
54c3405c-0f00-430e-b76d-81d5f7979ffa
Nickenig, G.
cbc6f830-b77e-4177-8e07-ad3ba8d6c18c
Curzen, N.
70f3ea49-51b1-418f-8e56-8210aef1abf4
Allocco, D.J.
3ec1184b-4d37-4340-9db6-9a90dd61e403
Dawkins, K.D.
528a45bb-0158-4dbf-af28-2a64d43244e3
April 2010
Grube, E.
abec52aa-1d3d-4a30-8fca-061cec6744d1
Schofer, J.
dcb1b4d3-8f78-4328-8212-5dd0393ad869
Hauptmann, K.E.
54c3405c-0f00-430e-b76d-81d5f7979ffa
Nickenig, G.
cbc6f830-b77e-4177-8e07-ad3ba8d6c18c
Curzen, N.
70f3ea49-51b1-418f-8e56-8210aef1abf4
Allocco, D.J.
3ec1184b-4d37-4340-9db6-9a90dd61e403
Dawkins, K.D.
528a45bb-0158-4dbf-af28-2a64d43244e3
Grube, E., Schofer, J., Hauptmann, K.E., Nickenig, G., Curzen, N., Allocco, D.J. and Dawkins, K.D.
(2010)
A novel paclitaxe-eluting stent with an ultrathin abluminal biodegradeable polymer 9-month outcomes with the JACTAX HD stent.
JACC Cardiovascular Interventions, 3 (4), .
(doi:10.1016/j.jcin.2009.12.015).
(PMID:20398872)
Abstract
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 ?m) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 ?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 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)
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More information
Published date: April 2010
Keywords:
biodegradable polymer, coronary restenosis, drug-eluting stent
Organisations:
Human Development & Health
Identifiers
Local EPrints ID: 355232
URI: http://eprints.soton.ac.uk/id/eprint/355232
ISSN: 1936-8798
PURE UUID: a268d49c-636a-4c43-9578-64bec3f82753
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Date deposited: 19 Aug 2013 10:58
Last modified: 15 Mar 2024 03:23
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Contributors
Author:
E. Grube
Author:
J. Schofer
Author:
K.E. Hauptmann
Author:
G. Nickenig
Author:
D.J. Allocco
Author:
K.D. Dawkins
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