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EXPEDITED PUBLICATION

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

Stefan Verheye, MD, PhD^_*,_*, Pierfrancesco Agostoni, MD^_*, Christophe L. Dubois, MD, Joseph Dens, MD, PhD, John Ormiston, MD, Stephen Worthley, MD^||, Brett Trauthen, MS^¶, Takao Hasegawa, MD^#, Bon-Kwon Koo, MD, PhD^#, Peter J. Fitzgerald, MD, PhD^#, Roxana Mehran, MD^_** and Alexandra J. Lansky, MD^_**

^_* Antwerp Cardiovascular Institute Middelheim, Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium
University Hospital Gasthuisberg, Leuven, Belgium
Oost-Limburg Hospital, Genk, Belgium
Auckland City Hospital, Auckland, New Zealand
^|| Royal Adelaide Hospital, Adelaide, Australia
^¶ Devax, Inc., Lake Forest, California
^# Stanford University Medical Center, Stanford, California
^_** Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York

Manuscript received November 19, 2008; revised manuscript received December 8, 2008, accepted December 10, 2008.

^_* Reprint requests and correspondence: Dr. Stefan Verheye, Antwerp Cardiovascular Institute Middelheim, Ziekenhuis Netwerk Antwerpen, Lindendreef 1, 2020 Antwerp, Belgium (Email: stefan.verheye{at}telenet.be).

The results of this study were presented at the 2008 Transcatheter Cardiovascular Therapeutics (TCT) Conference Proceedings (Late Breaking Clinical Trial session), Washington, DC, October 12 to 17, 2008.

Objectives: 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.

Background: Percutaneous treatment of coronary bifurcations is a predictor of adverse late outcomes, in part because of the lack of dedicated devices.

Methods: 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.

Results: 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%.

Conclusions: 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)

Key Words: coronary artery disease • Biolimus A9-eluting stent • bifurcation lesion • restenosis

Abbreviations and Acronyms   IVUS = intravascular ultrasound   MACE = major adverse cardiac event   MI = myocardial infarction   MLD = minimal luminal diameter   PCI = percutaneous coronary intervention   PV = parent vessel   RVD = reference vessel diameter   SB = side branch   TLR = target lesion revascularization

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