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Clinical and Angiographic Outcomes in Diabetics From the ENDEAVOR IV Trial

Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease

Ajay J. Kirtane, MD, SM^_*, Rikesh Patel, MD^_*, Charles O'Shaughnessy, MD, Paul Overlie, MD, Brent McLaurin, MD, Stuart Solomon, MD^||, Laura Mauri, MD, MSc^¶, Peter Fitzgerald, MD, PhD^#, Jeffrey J. Popma, MD^_**, David E. Kandzari, MD, Martin B. Leon, MD^_*,_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Elyria Memorial Hospital, Elyria, Ohio
Lubbock Heart Hospital, Lubbock, Texas
Anderson Medical Center, Anderson, South Carolina
^|| Methodist Hospital, Houston, Texas
^¶ Harvard Clinical Research Institute, Boston, Massachusetts
^# Stanford University, Stanford, California
^_** Caritas Cardiovascular Center, St. Elizabeth's Medical Center, Boston, Massachusetts
Scripps Clinic, La Jolla, California

^_* Reprint requests and correspondence: Dr. Martin B. Leon, Professor of Medicine, Columbia University College of Physicians and Surgeons, Associate Director, Center for Interventional Vascular Therapy, New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York 10032 (Email: mleon{at}crf.org).

Objectives: The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial.

Background: Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients. Although ZES has been associated with similar clinical efficacy compared with PES in the overall trial population of the ENDEAVOR IV trial, whether these results are maintained in the higher-risk restenosis subgroup of patients with DM has not been determined.

Methods: Clinical and angiographic outcomes were compared according to randomized treatment assignment to either ZES or PES.

Results: Baseline characteristics were similar among ZES (n = 241) and PES (n = 236) diabetic patients, with slightly longer lesion lengths in PES-treated patients (12.9 mm vs. 14.0 mm, p = 0.041). Among the 86 DM patients assigned to routine angiographic follow-up (18% of the overall DM cohort), in-stent percent diameter stenosis at 8 months was greater among ZES-treated patients (32.9 vs. 21.1, p = 0.023), with a trend toward higher in-stent late loss. One-year clinical outcomes were similar among DM patients treated with either ZES or PES (target vessel failure: 8.6% vs. 10.8%, p = 0.53; target lesion revascularization: 6.9% vs. 5.8%, p = 0.70; target vessel revascularization: 8.6% vs. 9.4%, p = 0.87). There were no significant interactions between DM status and stent type with respect to the outcomes measured, and the relative efficacy/safety of ZES and PES were similar among insulin- and noninsulin-requiring subgroups.

Conclusions: One-year clinical outcomes were similar among DM patients treated with ZES and PES in the ENDEAVOR IV trial. These findings parallel the overall trial results, which demonstrated similar efficacy and safety of ZES and PES for single de novo coronary lesions.

Key Words: diabetes mellitus • drug-eluting stent • Endeavor IV • zotarolimus

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent   DM = diabetes mellitus   IDDM = insulin-dependent diabetes mellitus   MACE = major adverse cardiac events   MLD = minimum lumen diameter   NIDDM = noninsulin-dependent diabetes mellitus   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent   QCA = quantitative coronary angiography   TLR = target lesion revascularization   TVR = target vessel revascularization   TVF = target vessel failure   ZES = zotarolimus-eluting stent

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