Author + information
- Received October 29, 2009
- Revision received March 23, 2010
- Accepted April 17, 2010
- Published online July 1, 2010.
- Emmanouil S. Brilakis, MD, PhD⁎,⁎ (, )
- John M. Lasala, MD, PhD†,
- David A. Cox, MD‡,
- Peter B. Berger, MD§,
- Thomas S. Bowman, MD, MPH∥,
- Ruth M. Starzyk, PhD∥ and
- Keith D. Dawkins, MD∥
- ↵⁎Reprint requests and correspondence:
Dr. Emmanouil S. Brilakis, VA North Texas Health Care System, The University of Texas Southwestern Medical Center at Dallas, Division of Cardiology (111A), 4500 South Lancaster Road, Dallas, Texas 75216
Objectives The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population.
Background Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective.
Methods The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving ≥1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria.
Results The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients.
Conclusions The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751)
- coronary artery bypass graft surgery
- paclitaxel-eluting stent
- percutaneous coronary intervention
- saphenous vein graft
This work was supported by Boston Scientific Corporation, Natick, Massachusetts. Dr. Brilakis has received speaker honoraria from St. Jude Medical, consulting fees from Medicure, and research support from Abbott Vascular. Dr. Lasala has received Speakers' Bureau and consulting fees from Boston Scientific Corporation. Dr. Cox has served on the Speakers' Bureau and Medical Advisory Board for Boston Scientific Corporation. Dr. Bowman is a full-time employee and stockholder of Boston Scientific Corporation. Dr. Starzyk is a full-time employee and stockholder of Boston Scientific Corporation. Dr. Dawkins is a full-time employee and stockholder of Boston Scientific Corporation.
- Received October 29, 2009.
- Revision received March 23, 2010.
- Accepted April 17, 2010.
- American College of Cardiology Foundation