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

Abstract

Background/ObjectivesThe purpose of this prospective, randomized, single-blind controlled clinical trial was to compare the effectiveness of a zotarolimus-eluting stent (ZoMaxx™) with a paclitaxel-eluting coronary stent (Taxus™ Express2™) in patients with angina pectoris and a single native coronary artery lesion between 10–28mm in length and 2.5–3.75mm in diameter. MethodsPatients were enrolled at 75 international institutions between June 2005 and November 2006. Results1099 (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). ConclusionsAt 9months, 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.