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Outcomes After Implantation of the TAXUS Paclitaxel-Eluting Stent in Saphenous Vein Graft Lesions

Results From the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) Program

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^||, Keith D. Dawkins, MD^||

^_* VA North Texas Healthcare System and University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
Washington University School of Medicine, St. Louis, Missouri
Lehigh Valley Hospital, Allentown, Pennsylvania
Geisinger Center for Health Research, Danville, Pennsylvania
^|| Boston Scientific Corporation, Natick, Massachusetts

^_* 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 (Email: esbrilakis{at}yahoo.com).

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)

Key Words: coronary artery bypass graft surgery • paclitaxel-eluting stent • percutaneous coronary intervention • saphenous vein graft

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DAPT = dual antiplatelet therapy   DES = drug-eluting stent(s)   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   RCT = randomized controlled trial   SES = sirolimus-eluting stent   ST = stent thrombosis   SVG = saphenous vein graft   TLR = target lesion revascularization   TVR = target vessel revascularization

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