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https://hdl.handle.net/2440/60851
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Type: | Journal article |
Title: | 9-Month Clinical, Angiographic, and Intravascular Ultrasound Results of a Prospective Evaluation of the Axxess Self-Expanding Biolimus A9-Eluting Stent in Coronary Bifurcation Lesions: The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) Study |
Author: | Verheye, S. Agostoni, P. Dubois, C. Dens, J. Ormiston, J. Worthley, S. Trauthen, B. Hasegawa, T. Koo, B. Fitzgerald, P. Mehran, R. Lansky, A. |
Citation: | Journal of the American College of Cardiology, 2009; 53(12):1031-1039 |
Publisher: | Elsevier Science Inc |
Issue Date: | 2009 |
ISSN: | 0735-1097 1558-3597 |
Statement of Responsibility: | Stefan Verheye, Pierfrancesco Agostoni, Christophe L. Dubois, Joseph Dens, John Ormiston, Stephen Worthley, Brett Trauthen, Takao Hasegawa, Bon-Kwon Koo, Peter J. Fitzgerald, Roxana Mehran, Alexandra J. Lansky |
Abstract: | <h4>Objectives</h4>This study sought to assess the safety and performance of the Axxess (Devax Inc., Lake Forest, California) self-expanding drug-eluting stent in coronary bifurcation lesions.<h4>Background</h4>Percutaneous treatment of coronary bifurcations is a predictor of adverse late outcomes, in part because of the lack of dedicated devices.<h4>Methods</h4>Patients with de novo bifurcation lesions were prospectively enrolled in a multicenter study. The Axxess stent was deployed at the level of the carina followed by additional sirolimus-eluting stents in the distal parent vessel (PV) and/or side branch (SB). All patients underwent clinical follow-up at 9 months; 150 were to receive control angiography and 76 were to receive intravascular ultrasound. The primary end point was the rate of major adverse cardiac events (MACE): a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Secondary end points included in-segment restenosis, late loss, and percent neointimal volume obstruction.<h4>Results</h4>Overall, 302 patients were treated with 299 Axxess stents (99%). Additional stenting of 1 branch was performed in 21.7% of patients (17.7% PV, 4% SB), and of both branches in 64.7%. At 9 months, 99.3% of patients returned for clinical follow-up; from the angiographic and IVUS substudies, 93.3% and 89.4% returned. The cumulative 9-month MACE rate was 7.7% (0.7% death, 3.3% non-Q-wave MI, 1.0% Q-wave MI, 4.3% TLR). Subacute and late stent thrombosis occurred in 0.7% and 0.3% of patients. Total restenosis was 6.4% (3.6% PV, 4.3% SB), late loss was 0.20 +/- 0.41 mm in the PV and 0.17 +/- 0.34 mm in the SB. In the Axxess stent segment, percent neointimal volume obstruction was 4.3 +/- 5.2%.<h4>Conclusions</h4>This prospective multicenter study confirms the safety and performance of the Axxess stent in bifurcation lesions. (Drug-Eluting Stent Intervention for Treating Side Branches Effectively; ACTRN12606000259549). |
Keywords: | coronary artery disease Biolimus A9-eluting stent bifurcation lesion restenosis |
Rights: | Copyright © 2009 American College of Cardiology Foundation. |
DOI: | 10.1016/j.jacc.2008.12.012 |
Published version: | http://dx.doi.org/10.1016/j.jacc.2008.12.012 |
Appears in Collections: | Aurora harvest 5 Medicine publications |
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