Llow on. It includes 871 patients in the TAXUS ATLAS15 and at least 1675 patients enrolled included on labels in the TAXUS Libert ŧ. Medically treated subset of data on the medically treated diabetic patients IkB Signaling with diabetes will be analyzed by a prior agreement with the FDA. The label on medical treatment of diabetic patient subset will be analyzed for a pre-specified 12 months TVF rate. Based on the observed rate of 7.1% compared to TAXUS ARRIVE registries TVF, including 3 with an adjustment of 1.9% for compulsory collection of heart enzyme in diabetic patients in the TAXUS Libert ŧ after admission, the rate of FST under 12 months of medical treatment on the label of diabetic patients with TAXUS Libert é is treated is 9.0% .18 The performance target is 12.6% with a margin of 3, 6%. For a Level 1 facial significance level of 5%, at least 470 on the label medically treated diabetic patients ben To do prior to supply at least 80% power, the performance goal to meet FST of 12.6%. W is While in 1512 there are labels on patients for the analysis of 12 months to be, we believe that about 484 drug TAXUS Libert é label S-treated diabetic patients to be available for historical rate of 32% for the analysis of drug s-treated diabetic patients in the TAXUS ARRIVE. Organization of study and ethical considerations of data of all patients with MACCE, ST or green Eren bleeding and an additional keeping sample of 20% of patients per site will be monitored by Boston Scientific. The institutional review board at each participating center must be approved the study protocol and consent explanation, all subjects Be posted tion before enrollment. An independent Ngiges Clinical Events Committee will zerebrovaskul to all reported events of death from any cause, big e Re cardiacand events, bleeding and agree ST.
An independent Independent Data Monitoring Committee is responsible for the supervision of all adverse events reported and aggregated data on the safety of the incidence of serious adverse events and other trends that can Amendment or repeal of the warrant monitoring studies by the Board. Study organization and composition of the Monitoring Committee are listed in Appendix F RESTRICTIONS Website will on-line design of the study are several restrictions in the interpretation of the results of the study. The TAXUS Libert ŧ used to study the admission control Histories as comparators for the prime Ren endpoint. Despite the use of propensity score method, historical data may be subject to bias due to differences in patient complexity t and processing modes between TAXUS and TAXUS Libert é Express. The patients in the historical comparison group were prescribed thienopyridines commercially Ltlich at the time of enrollment for the TAXUS ATLAS studies and range, may need during the TAXUS Libert ŧ post licensure study uses the most recently approved prasugrel. With this new thienopyridine on clinical outcomes and can therefore potentially confound the axitinib interpretation of the results on the efficacy of the stent. It will be important, ST and bleeding examines prices in this study as part of the previously Ver published shall result from the use of prasugrel with DESs.8 The exclusion of some conditions of high high-risk patients, the results of m for may have not generalizable to all potential patients stent. The authors alone are responsible.