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

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• 作者：William A. Gray^a ; ¹ ; Alan C. Yeung^b ; ¹ ; Donald E. Cutlip^c ; ¹ ; Jeffrey J. Popma^d ; ¹ ; Peter J. Fitzgerald^b ; ¹ ; David O. Williams^e ; ¹ ; Hubertus Heuer^f ; ¹ ; Charles D. O'Shaughnessy^g ; ¹ ; Paul A. Overlie^h ; ¹ ; J. Tift Mannⁱ ; ¹ ; Louis A. Cannon^j ; ¹ ; James B. Hermiller^k ; ¹ ; Timothy D. Henry^l ; ¹ ; Robert Whitbourn^m ; ¹ ; Thomas D. Stuckeyⁿ ; ¹ ; Mark G. Midei^o ; ¹ ; Jessie Coe^p ; ¹ ; Lewis B. Schwartz^p ; ¹ ; ^{lewis.schwartz@abbott.com}
• 关键词：Zotarolimus ; Drug-eluting stents ; Percutaneous coronary intervention ; Restenosis
• 刊名：International Journal of Cardiology
• 出版年：2012
• 期刊代码：128_01675273
• 类别：med
• 出版时间：17 May, 2012
• 卷：157
• 期：1
• 页码：96-101
• 文件大小：381 K

摘要

Background/Objectives

The purpose of this prospective, randomized, single-blind controlled clinical trial was to compare the effectiveness of a zotarolimus-eluting stent (ZoMaxx鈩? with a paclitaxel-eluting coronary stent (Taxus鈩?Express²鈩? in patients with angina pectoris and a single native coronary artery lesion between 10-28 mm in length and 2.5-3.75 mm in diameter.

Methods

Patients were enrolled at 75 international institutions between June 2005 and November 2006.

Results

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).

Conclusions

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.