November 14, 2020
ALPHEUS Trial Finds Ticagrelor Is Not Superior to Clopidogrel to Reduce MI Risk During PCI
November 14, 2020—The use of ticagrelor was found to be not superior to clopidogrel in the reduction of the rate of heart attack or severe complications among patients undergoing elective percutaneous coronary intervention (PCI) in the randomized, international, multicenter ALPHEUS trial.
The findings were presented in a late-breaking session at the American Heart Association’s (AHA) Scientific Sessions 2020 held as a virtual meeting on November 13-17. The study was published simultaneously by Professor Johanne Silvain, MD, et al in The Lancet.
According to the AHA, the ALPHEUS trial examined whether ticagrelor, which is a more potent antiplatelet medication than clopidogrel (the standard of care), may reduce the rate of heart attack and complications around the time of the procedure for patients who are considered high risk because of at least one additional underlying condition (eg, renal insufficiency, diabetes, being overweight, a previous acute coronary syndrome, or heart failure) or because of a high-risk procedure (eg, multiple stents needed, bifurcation stenting, left main).
The risk of severe complications, including stent clots, stroke, and death, during PCI is < 1%. In the ALPHEUS trial, the rate was 0.5%. Some patients experience heart attacks provoked by the PCI procedure.
Prof. Silvain, an interventional cardiologist and Director of the Coronary Intensive Care Unit at the Institut de Cardiologie of the Hospital Pitié-Salpêtrière in Paris, France, commented in the AHA announcement, “While ticagrelor has been shown in previous studies to be beneficial in reducing blood clots among people who experienced a sudden blockage in a coronary artery, it has never been evaluated in patients undergoing elective PCI with more stable heart conditions.”
As summarized in the AHA announcement, the ALPHEUS trial was composed of 1,833 adults with heart disease enrolled at 49 centers in France and the Czech Republic. A control group of patients received clopidogrel plus aspirin before PCI and for 30 days after the procedure. The experimental group received ticagrelor plus aspirin before PCI and for 30 days after.
The study, which was conducted over more than 3 years, found the following:
- The rate of periprocedural heart attack and severe complications, including stent clots, stroke, and death, was similar between the control group and the experimental group.
- There was no increase in excessive bleeding 48 hours after PCI among the patients treated with ticagrelor compared to the control group.
“These results show there is no scientific data to support a change in the standard of care,” stated Prof. Silvain in the AHA press release. “The use of ticagrelor should be reserved for treating patients who experienced a sudden blockage in a coronary artery (acute coronary syndrome), not those who have stable heart conditions and elect PCI.”
Regarding study limitations, Prof. Silvain advised, “It was an open-label trial; myocardial infarction and injury were used as the clinical outcome as hard clinical endpoints, which are rare in elective PCI. Patients under chronic clopidogrel therapy were included, and all troponin assays were allowed to reflect real life but may have brought heterogeneity.”