WASHINGTON, DC March 27, 2014 A new angiographic analysis of the CHAMPION PHOENIX trial examined the incidence and impact of stent thrombosis (ST) in patients undergoing percutaneous coronary intervention (PCI). Results of the study were released today and will be presented March 30 at the American College of Cardiology 63rd Annual Scientific Session.
CHAMPION PHOENIX was a prospective, double-blind, active-controlled trial which randomized 11,145 patients to receive intravenous cangrelor or oral clopidogrel administered at the time of PCI. In a previous analysis presented at TCT 2013 and published in the Journal of the American College of Cardiology, cangrelor significantly reduced periprocedural and 30-day ischemic events in patients undergoing PCI.
In this new analysis, an independent core laboratory (CRF) blinded to the treatment performed the angiographic analysis of 10,939 of the randomized patients. Stent thrombosis was defined as the occurrence of either intraprocedural ST (IPST) or ARC defined ST (definite or probable). Adverse events were adjudicated by an independent clinical events committee.
ST occurred in 120 patients (1.1 percent) at 48 hours and in 175 patients (1.6 percent) at 30 days. The occurrence of ST at 48 hours and 30 days was associated with a marked increase in 30-day mortality (OR [95%CI] = 15.3 [8.6, 27.2], p<0.001; and 55.2 [36.6, 83.3] p<0.001, respectively). IPST, ARC acute ST (≤24 hrs), and ARC subacute ST (1-30 days) occurred in 89 (0.8 percent), 32 (0.3 percent), and 60 (0.5 percent) patients respectively. Each type of ST was also associated with an increase in 30-day mortality (IPST: 17.4 [8.4, 36.1], p<0.001, ARC acute ST: 43.3 [18.1, 103.5], p<0.001, ARC sub-acute ST: 189.1, [107.9, 331.4], p<0.001).
"Regardless of the exact type of stent thrombosis, it remains associated with a high rate of death," stated Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular
|Contact: Judy Romero|
Cardiovascular Research Foundation