The relation between clinical features, angiographic findings, and the target lesion revascularization rate in patients receiving the endeavor zotarolimus-eluting stent for treatment of native coronary artery disease: an analysis of ENDEAVOR I, ENDEAVOR II, ENDEAVOR II Continued Access Registry, and ENDEAVOR III.

ABSTRACT

The clinical and angiographic factors that predict clinically driven target lesion revascularization (TLR) in patients treated with the zotarolimus-eluting stent (ZES) are not known. Accordingly, the differences between ZES-treated patients who required TLR and ZES-treated patients who did not require TLR were examined in 1,306 patients enrolled in 4 pivotal trials of the Endeavor ZES (Medtronic Vascular, Santa Rosa, CA) for the treatment of symptomatic native coronary artery disease. TLR was performed in 64 patients (4.9%) by 9 months, with most cases (89.1%) occurring after 30 days. ZES-treated patients who required TLR had a greater incidence of 2- or 3-vessel disease (p <0.01), more stents implanted (p = 0.05), and lower device (p = 0.04) and procedure (p <0.01) success rates than ZES-treated patients who did not require TLR. The stents implanted in ZES-treated patients who later required TLR were also longer (p = 0.02) and smaller in diameter (p <0.01). Most angiographic outcomes at 8 months (12 months for ZES-treated patients in ENDEAVOR I) were worse for ZES-treated patients who later required TLR. At 9 months, 10.9% of the ZES-treated patients who required TLR had had myocardial infarctions, compared with 2.2% who did not require TLR (p = 0.001). Multivariate analysis identified older age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.00-1.06), male sex (OR, 1.79; 95% CI, 0.88-3.65), and longer lesion length (OR, 1.03; 95% CI, 0.99-1.07) as risk factors for TLR after ZES implantation (with a C statistic of 0.61, suggesting a modest discriminatory value). These data provide insight into the clinical and angiographic factors that predict TLR at 9 months in ZES-treated patients, making possible the focused surveillance of selected ZES-treated patients who might be at greater risk of TLR.