Medtronic Says Study Data Published on Stent in Diabetes Patients

The current issue of JACC: CardiovascularInterventions, a peer-reviewed journal published by the American College ofCardiology, includes an article that describes how the Resolute Integritydrug-eluting stent from Medtronic, Inc. (NYSE: MDT) became the first and onlydevice of its kind to be approved by the U.S. Food and Drug Administration(FDA) with a specific indication for treating the coronary artery disease ofpatients with diabetes mellitus.A common comorbidity of coronary artery disease, diabetes affectsapproximately one-third of patients who receive coronary stents andhistorically has been associated with adverse clinical outcomes. New researchpresented in the journal article, however, shows that treatment with theResolute drug-eluting stent led to similarly positive outcomes for diabetespatients who were not taking insulin and for patients without diabetes. It wassponsored by Medtronic.Titled "Clinical Outcome of Patients With and Without Diabetes Mellitus AfterPercutaneous Coronary Intervention with the Resolute Zotarolimus-ElutingStent" (R-ZES), the article presents the results of two separate analyses ofpatient-level data from the global RESOLUTE clinical program, which enrolled atotal of 5,130 patients who received a Resolute drug-eluting stent asparticipants in one of five studies conducted in the United States andinternationally.The authors' conclusions state: "The R-ZES is safe and effective in patientswith diabetes. Long-term clinical data of patients with non-insulin-treateddiabetes are equivalent to patients without diabetes. Patients withinsulin-treated diabetes remain a higher risk subset."Two Analyses, Similar FindingsOne analysis reported in the article evaluated the performance of the devicein the 878 standard-risk diabetes patients who received it. Prospectivelydetermined in conjunction with the FDA, it set a 12-month target vesselfailure (TVF) rate of 14.5 percent as a performance goal.The actual rate of TVF at 12 months among these standard-risk diabetespatients was significantly lower at 7.8 percent (p<0.001), demonstratingsuperiority of the Resolute drug-eluting stent over first-generation devicesin this patient subset. The results of this analysis led to FDA approval of aunique diabetes indication for the Resolute Integrity drug-eluting stent inFebruary 2012.This analysis also found low and comparable rates of target lesion failure(TLF) at two years in the patients with non-insulin-treated diabetes whencompared to the patients without diabetes (8.0% vs. 7.1%). In addition, itfound a predictably higher two-year TLF rate in the patients withinsulin-treated diabetes (13.7%).(Target vessel failure is a composite endpoint that includes cardiac death,myocardial infarction and revascularization attributable to any part of thestented vessel; target lesion failure includes the same components, but onlyas attributable to the stented segment of the vessel.)Another analysis reported in the article evaluated the cumulative incidence ofTLF at two years for all 5,130 patients, many of whom had complex coronaryartery disease.For this analysis, the patients were first divided into two groups: those withdiabetes (1,535; 30%) and those without diabetes (3,595; 70%). The diabetespatients were then divided into two groups: those who were taking insulin(455; 30%) and those who were not taking insulin (1,080; 70%).This analysis yielded a similar finding. Specifically, it found low andcomparable two-year rates of TLF in patients with non-insulin-treated diabetesand patients without diabetes (8.9% vs. 8.4%) -- and a predictably higher rateof TLF at two years in patients with insulin-treated diabetes (16.7%)."These two analyses offer interventional cardiologists worldwide increasedconfidence when making treatment decisions about the coronary artery diseaseof patients with diabetes mellitus, who have historically experienced worseclinical outcomes following coronary stent procedures," said lead author Prof.Dr. Sigmund Silber, director of the Heart Center at the Isar in Munich,Germany.The strong performance of the Resolute drug-eluting stent in patients withdiabetes -- both in clinical studies and real-world clinical practice --advances the growing body of evidence that warranted the device's uniquediabetes indication in the United States.In collaboration with leading clinicians, researchers and scientistsworldwide, Medtronic offers the broadest range of innovative medicaltechnology for the interventional and surgical treatment of cardiovasculardisease and cardiac arrhythmias. The company strives to offer products andservices that deliver clinical and economic value to healthcare consumers andproviders around the world.