Chiesi USA’s Kengreal Evaluated in Post Hoc Analysis of CHAMPION PHOENIX

January 25, 2022—Chiesi USA announced the publication of a post hoc analysis of the CHAMPION PHOENIX clinical trial that evaluated the timing, number, and type of early cardiovascular events that occurred with treatment of the company’s Kengreal (cangrelor) compared to clopidogrel in patients undergoing percutaneous coronary intervention (PCI). Chiesi USA is the United States affiliate of the Italian-based Chiesi Farmaceutici, an international research-focused health care group (Chiesi Group).

Chiesi stated that Kengreal is an intravenous P2Y12 platelet inhibitor indicated as an adjunct to PCI to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

The analysis was published by Matthew A. Cavendar, MD, et al in Circulation: Cardiovascular Interventions.

The company noted that the overall trial results of CHAMPION PHOENIX showed a significant benefit in the primary endpoint and key secondary endpoint. The overall results were published in 2013 by Deepak L. Bhatt, MD, et al in The New England Journal of Medicine (2013;368:1303-1313).

According to Chiesi, the current post hoc analysis found that in the first 2 hours postrandomization, Kengreal significantly decreased the primary composite endpoint of death, MI, ischemia-driven revascularization (IDR), or ST by 25% when compared with clopidogrel (4.1% vs 5.4%; hazard ratio, 0.76 [95% CI, 0.64-0.90]; P = .002).

Similar findings were seen when evaluating the secondary composite endpoint of death, Society for Coronary Angiography and Intervention (SCAI)–defined MI, IDR, or Academic Research Consortium (ARC)–defined ST at 2 hours (0.9% vs 1.6%; hazard ratio, 0.57 [95% CI, 0.40-0.80]; P = .001). There was no rebound increase in cardiovascular events during the time period in which patients were transitioned from Kengreal to an oral P2Y12 inhibitor.

The majority of cardiovascular events (63%), as defined within the secondary composite endpoint, occurred within 2 hours after randomization, supporting previous findings of the increased risk of ischemic events in the early time period around PCI. The most common early event was SCAI-MI (44%), followed by ARC-ST (7%), IDR (7%), and death (5%), noted the company.

Chiesi stated that the analysis presents findings that supplement the predefined, primary result of the CHAMPION PHOENIX trial. The trial was not designed to examine the impact of Kengreal versus clopidogrel in the first 2 hours postrandomization.

Additionally, this analysis characterizes a post hoc secondary composite endpoint described earlier that was not part of the original trial design.

Dr. Bhatt commented in the company’s press release, “These data add to the main results as well as multiple prior analyses from CHAMPION PHOENIX demonstrating the efficacy of cangrelor in reducing important ischemic events, in particular in the early period of PCI when patients are at the highest risk of complications.”

Robert A. Harrington, MD, added, “These results further strengthen the case for using cangrelor in appropriate PCI patients.”

Drs. Bhatt and Harrington are the CHAMPION PHOENIX study cochairs. Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts. Dr. Harrington is Chairman of Medicine and Arthur L. Bloomfield Professor of Medicine at Stanford University in Stanford, California.

As summarized by the Chiesi press release, the CHAMPION PHOENIX trial was a randomized, double-blind, placebo-controlled phase III trial part of a clinical development program that established the efficacy and safety of Kengreal. The trial was composed of 11,145 patients undergoing either urgent or elective PCI and receiving guideline-recommended therapy. Patients being treated with Kengreal received a bolus followed by an infusion for 2 hours or for the duration of the procedure, whichever was longer. Patients received a loading dose of 600 or 300 mg of clopidogrel at the end of the infusion. The trial found that Kengreal reduced the primary composite endpoint of death, MI, IDR, or ST at 48 hours in patients undergoing PCI, as well as the key secondary endpoint of ST.