There were no significant differences in the 30-day primary composite end point of death, or target vessel revascularization. Only MI occurred (in 8% of the preload and 11% of the in-lab group). There were also no significant differences in the secondary end points of postprocedural markers of myocardial injury above the upper limit of normal, or in postprocedural peak levels of those markers.
The occurrence of bleeding—another secondary end point—also did not differ between preload and in-lab groups. Only minor bleeding occurred (in 4% of the preload and in 5% of the in-lab patients), Dr. Di Sciascio reported.
Point-of-care aggregometry measurements of platelet reactivity did differ significantly between the two groups at the time of PCI and again at 2 hours post procedure, but were no longer significantly different at 6 and 24 hours.
In a critical appraisal, Dr. Daniel I. Simon called ARMYDA-5 “a very important study that has a number of strengths.” But its biggest weakness was a lack of adequate statistical power. An example of a better-powered study is ISAR-REACT-2, which compared abciximab before PCI with placebo in more than 2,000 patients and yielded event rates similar to those of ARMYDA-5, said Dr. Simon, chief of the division of cardiovascular medicine at Case Western Reserve University, Cleveland.