TWENTE Study: The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente: study design, rationale and objectives
- PMID: 20730003
- PMCID: PMC2922782
- 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
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.
Figures

References
-
- Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schomig A. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2006;27:260-6. - PubMed
-
- Vermeersch P, Agostoni P, Verheye S, Van den HP, Convens C, Bruining N, et al. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol. 2006;48:2423-31. - PubMed
-
- Briguori C, Colombo A, Airoldi F, Focaccio A, Iakovou I, Chieffo A, et al. Sirolimus-eluting stent implantation in diabetic patients with multivessel coronary artery disease. Am Heart J. 2005;150:807-13. - PubMed
-
- Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370:937-48. - PubMed
-
- Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009;119:3198-206. - PubMed
LinkOut - more resources
Full Text Sources