Patients were enrolled at 75 international institutions between June 2005 and November 2006.
1099 (1672 originally planned) patients received 557 ZoMaxx and 542 Taxus stents: cohorts were well-matched for diabetes (27%vs. 27%), reference vessel diameter (2.73 卤 0.46 mm vs. 2.74 卤 0.45 mm) and lesion length (14.8 卤 6.7 mm vs. 14.3 卤 6.4 mm). Nine month clinical and angiographic follow-up was available in 1052/1099 (96%) and 649/836 (78%) patients, respectively. The safety profiles for the two stents (myocardial infarction (MI), cardiac death and/or target vessel revascularization (TVR)) were similar (ZoMaxx 8.7%vs. Taxus 6.9%, p = NS). The primary endpoint of 9-month TVR occurred more frequently after treatment with ZoMaxx (6.8%) as compared with Taxus (4.2%), therefore the primary clinical endpoint was not met. However, the 9-month in-segment late lumen loss for ZoMaxx (0.29 卤 0.47 mm) and Taxus (0.22 卤 0.41 mm, p = NS) were similar, thus satisfying the primary angiographic endpoint. Secondary endpoints of the rates of in-segment and in-stent binary restenosis were also similar (5.9%vs. 5.8%, 7.8%vs. 7.9%, respectively).
At 9 months, the ZoMaxx stent failed to achieve the primary endpoint of non-inferiority in TVR to the Taxus stent, but safety endpoints were equal between the two stent systems.