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

M W Z Basalus; K Tandjung; K G van Houwelingen; M G Stoel; F H A F de Man; J W Louwerenburg; S A M Saïd; G C M Linssen; M A W J Kleijne; J van der Palen; J Huisman; P M J Verhorst; C von Birgelen

doi:10.1007/BF03091792

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

Neth Heart J. 2010 Aug;18(7-8):360-4. doi: 10.1007/BF03091792.

Authors

M W Z Basalus¹, K Tandjung, K G van Houwelingen, M G Stoel, F H A F de Man, J W Louwerenburg, S A M Saïd, G C M Linssen, M A W J Kleijne, J van der Palen, J Huisman, P M J Verhorst, C von Birgelen

Affiliation

¹ Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.

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.