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.

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 > or =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).