Clinical and Angiographic Outcomes in Diabetic Patients following Single or Multivessel Stenting in the COSTAR II Randomized Tr

Volume 20 - Issue 7 - July, 2008
Posted on: 8/1/08
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Author(s):

Dean J. Kereiakes, MD, John L. Petersen, MD, Wayne B. Batchelor, MD, Peter J. Fitzgerald, MD, Roxana Mehran, MD, Alexandra Lansky, MD, Ichizo Tsujino, MD, Joachim Schofer, MD, Christophe Dubois, MD, Stefan Verheye, MD, ^{Ecaterina Cristea, MD, Jyotsna Garg, MD, William Wijns, MD, Mitchell W. Krucoff, MD}

The prevalence of diabetes has reached epidemic proportion in many sectors of the world.¹ Atherosclerotic cardiovascular disease has been correlated with the presence, duration and severity of diabetes.^2,3 In addition, both clinical and angiographic outcomes following percutaneous coronary intervention (PCI) are worse in patients with diabetes when compared with their nondiabetic counterparts.^4,5 Although coronary stent implantation improved the outcomes of diabetic patients compared with balloon angioplasty due to a reduction in periprocedural and late (restenosis) complications,^6–8 restenosis following bare-metal stent (BMS) deployment remained a significant limitation to PCI in this patient population.^9,10 Stent-based elution of either paclitaxel or sirolimus from biostable polymers has been demonstrated to reduce angiographic and clinical restenosis compared with BMS deployment in patients both with or without diabetes mellitus.^11–14 However, the safety and efficacy of paclitaxel elution from a stent-based bioresorbable polymer in patients with diabetes mellitus has not been studied. Furthermore, the importance of hyperglycemia in the absence of diagnosed diabetes mellitus as a determinant of clinical and/or angiographic outcomes following coronary stent deployment is inadequately defined.^15,16 Therefore, prespecified subgroup analysis of outcomes in patients with diagnosed diabetes mellitus, and of those with elevated glycolated hemoglobin (HbA1c) in the absence of known diabetes was undertaken from all patients enrolled in the CObalt chromium STent with Antiproliferative for Restenosis (COSTAR) II trial. Study design and patient population. The COSTAR II study design has been described.^17,18 Briefly, COSTAR II is a prospective, multicenter, single-blind, asymmetric (3:2), randomized trial comparing clinical and angiographic outcomes following deployment of the CoStar (Conor MedSystems, Menlo Park, California) compared with the Taxus (Boston Scientific, Natick, Massachusetts) paclitaxel drug-eluting stent (DES) for elective PCI in patients with de novo single- or multivessel coronary artery disease (CAD). The central hypothesis of the COSTAR II trial was that the CoStar stent is noninferior to the Taxus stent for the treatment of patients with symptomatic CAD.
Prespecified subgroup analyses included patients with diabetes, multivessel (versus single-vessel) stented cohorts as well as patients who required the provisional use of overlapping stents. Subject inclusion and exclusion criteria have been described^17,18 and were similar to those of the Taxus IV study,¹² with the exception being the inclusion of patients with 1-, 2- or 3-vessel CAD. Dual antiplatelet therapy (aspirin plus thienopyridine) was prescribed by protocol for 6 months following stent deployment. The study protocol compiled with the Declaration of Helsinki and was approved by the institutional review boards of all participating centers. All participating subjects signed an informed consent.