TWENTE Study: The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente: study design, rationale and objectives

Abstract

Background. New-generation drug-eluting stents (DES) may solve several problems encountered with first-generation DES, but there is a lack of prospective head-to-head comparisons between new-generation DES. In addition, the outcome of regulatory trials may not perfectly reflect the outcome in 'real world' patients.Objectives. To compare the efficacy and safety of two new-generation DES in a 'real world' patient population.Methods. A prospective, randomised, single-blinded clinical trial to evaluate clinical outcome after Endeavor Resolute vs. Xience V stent implantation. The primary endpoint is target vessel failure at one-year follow-up. In addition, the study comprises a two-year and an open-label five-year follow-up. (Neth Heart J 2010;18:360-4.).

Keywords: Drug-Eluting Stents; Angioplasty, Transliminal, Percutaneous Coronary; Coronary Artery Diseases; Randomized Controlled Trial; Thrombosis.

Figure 1

Geometry and surface morphology of Endeavor Resolute and Xience V. Micro-computed tomography images of Endeavor Resolute (A) and Xience V (B). Scanning electron microscopic images of Endeavor Resolute (C) and Xience V (D) (images from ongoing bench side studies in DES, performed by C. von Birgelen and co-workers, University of Twente, Enschede, the Netherlands.