The randomized RIGHT trial, testing 48 hours of post-PCI anticoagulation in STEMI patients, failed to document either benefit or increased risk.
Each of the 53 participating Chinese centers selected one of the anticoagulation regimens. Matching placebos were employed in the double-blind design. All received bivalirudin anticoagulation during PCI. Exclusion criteria included unstable disease, such asFor the composite primary endpoint of all-cause death, non-fatal MI, nonfatal, stent thrombosis, or urgent revascularization at 30 days, there was no difference between PPA and placebo. The event rate in both arms was 2.5%.
For the primary safety endpoint of Bleeding Academic Research Consortium grade 3 to 5 bleeding, the slight increase in events among those in the placebo group did not approach statistical significance . On other definitions of bleeding, which were secondary endpoints, PPA and placebo also did not differ significantly.
"There are a variety of anticoagulants employed in a variety of doses [for PPA] but we have very limited data. The research question is totally appropriate," he said. However, he asked,"What went wrong? Was it the drugs, the trial, or both?"trial, which did show a benefit from a single dose of bivalirudin following PCI relative to two other comparators. In that study, STEMI patients randomized to bivalirudin received a bolus of 0.75 mg/kg followed by an infusion of 1.
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