Icosapent ethyl reduces CV events in patients with prior PCI: REDUCE-IT PCI
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Compared with placebo, icosapent ethyl reduced first and total MACE in patients with prior PCI, according to results from REDUCE-IT PCI presented at the virtual TCT Connect.
In a subgroup analysis of 3,408 patients (median age, 63 years; 21% women) from REDUCE-IT with elevated triglycerides and other risk factors who had previously undergone PCI, those assigned icosapent ethyl (Vascepa, Amarin) had lower risk for the primary outcome of first incidence of CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina compared with those assigned placebo during a median follow-up duration of approximately 5 years (25.6% vs. 37.6%; HR = 0.66; 95% CI, 0.58-0.76; absolute risk reduction, 8.5%; number needed to treat to prevent one event = 12), Benjamin E. Peterson, MD, MPH, interventional cardiology fellow at Brigham and Women’s Hospital, said during a presentation.
The key secondary endpoint of CV death, nonfatal MI and nonfatal stroke was also lower in the icosapent ethyl group across the 5-year median follow-up (15.4% vs. 23.5%; HR = 0.66; 95% CI, 0.56-0.79; absolute risk reduction, 5.4%; number needed to treat to prevent one event = 19), he said.
In addition, he said, the icosapent ethyl group had a 39% reduction in total events, including first events and any subsequent events across the 5-year median follow-up (RR = 0.61; 95% CI, 0.52-0.72).
“There was a 34% reduction in first events, a 40% reduction in second events and a 50% reduction in third or greater events,” Peterson said during the presentation.
Compared with the placebo group, the icosapent ethyl group also had lower rates of CV death/nonfatal MI (HR = 0.68; 95% CI, 0.56-0.82), any MI (HR = 0.66; 95% CI, 0.53-0.82), urgent or emergent revascularization (HR = 0.65; 95% CI, 0.52-0.8), CV death (HR = 0.64; 95% CI, 0.46-0.9), hospitalization for unstable angina (HR = 0.59; 95% CI, 0.44-0.79), any stroke (HR = 0.62; 95% CI, 0.41-0.92) and total mortality/nonfatal MI/nonfatal stroke (HR = 0.72; 95% CI, 0.61-0.85), Peterson said.
Consistent with the main overall study results, the icosapent ethyl group in the subgroup of patients with prior PCI had more atrial fibrillation/atrial flutter (3.4% vs. 2.2%; P = .04); there were no differences between the groups in any bleeding (P = .6) or serious bleeding (P = .42), he said.
“These data reflect the substantial impact of icosapent ethyl on the at-risk REDUCE-IT patient population, including patients with a history of PCI,” Peterson said during the presentation.
All patients had fasting triglycerides 135 mg/dL to 499 mg/dL and established CVD or diabetes plus other risk factors.
In a discussion after the presentation, the late Anthony H. Gershlick, MD, distinguished professor of medicine at University Hospitals of Leicester, United Kingdom, called the results “the most extraordinary thing I’ve seen in a long while” and asked what the mechanisms behind them might be.
Peterson said triglycerides were only modestly reduced in the icosapent ethyl group, but “this trial had comparable reduction in the inflammatory markers as was seen in CANTOS. The mechanism behind that is not totally understood, but there is a strong anti-inflammatory component.” He also noted that the EVAPORATE study found icosapent ethyl was associated with slowing of plaque progression at 18 months.
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Peterson BE, et al. TCT Connect 2020 Best of Abstracts. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
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