A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: Final results of the ZoMaxx II trial
International Journal of Cardiology, 05/16/2012
Gray WA et al. – 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.Methods
- 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±0.46mm vs. 2.74±0.45mm) and lesion length (14.8±6.7mm vs. 14.3±6.4mm).
- 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±0.47mm) and Taxus (0.22±0.41mm, 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).