Other limitations in the design of TACT further undermine its reliability. In studying a controversial therapy, the primary end point should include the most objective and reliable components, such as death, stroke, and myocardial infarction. In TACT, the study included 2 less reliable end points, coronary revascularization and hospitalization for angina. These “softer” end points represent 318 of 483 events reported as primary end point events. If any unblinding occurred, investigator biases could potentially influence the decision to hospitalize or revascularize individual patients. During the study, enrollment proceeded at such a slow rate that the trial design was altered midway through the study, which is never desirable. In addition, conducting 11 interim analyses is highly unusual and increases the risk that the study was stopped exactly at the point when marginal “significance” was reached.