EVOLVE II DM Clinical Trial. Presented by Stephan Windecker, MD at PCR 2015.
P-value from the one-sided Clopper-Pearson test is <0.025, the 12-month TLF rate from SYNERGY is concluded to be less than the performance goal (14.5%)
* One-sided 97.5% Clopper Pearon Upper Confidence Bound (UCB)
Target lesion failure (TLF) defined as: Cardiac death, or MI related to the target vessel (based on CK-MB >3x URL), or Ischemia-driven target lesion revascularization
EVOLVE II DM Clinical Trial. Presented by Ian T. Meredith, AM, MBBS, PhD at PCR 2016.
^ Cutlip et al, Circulation. 2007; 115(17):2344;
* Spontaneous MI was defined as the rise and/or fall of cardiac biomarkers with ≥1 value >99th percentile of the upper reference limit (URL) with ≥1 of the following: symptoms of ischemia, ECG changes, and or evidence of loss of myocardium. Peri-PCI MI was defined by any of the following: i) CK-MB >3X URL within 48 hours, ii) new pathological Q waves, iii) autopsy evidence. All ST were definite.