Background Patients who undergo
percutaneous coronary intervention (PCI) are at increased risk for recurrent cardiovascular events despite aggressive medical
therapy. Methods and Results This post hoc analysis focused on the subset of patients with prior PCI enrolled in REDUCE-IT (Reduction of Cardiovascular Events With
Icosapent Ethyl-Intervention Trial), a multicenter, randomized, double-blind, placebo-controlled trial of
icosapent ethyl versus placebo.
Icosapent ethyl was added to
statins in patients with
low-density lipoprotein cholesterol <100 mg/dL and fasting
triglycerides 135-499 mg/dL. The primary end point was a composite of cardiovascular death, nonfatal
myocardial infarction, nonfatal
stroke, coronary revascularization, or
unstable angina requiring hospitalization. There were 8179 patients randomized in REDUCE-IT followed for a median of 4.9 years, and 3408 (41.7%) of them had a prior PCI with a median follow-up of 4.8 years. These patients were randomized a median of 2.9 years (11 days to 30.7 years) after PCI. Among patients treated with
icosapent ethyl versus placebo, there was a 34% reduction in the primary composite end point (hazard ratio [HR], 0.66; 95% CI, 0.58-0.76; P<0.001; number needed to treat4.8 years=12) and a 34% reduction in the key secondary composite end point of cardiovascular death, nonfatal
myocardial infarction, or nonfatal
stroke (HR, 0.66; 95% CI, 0.56-0.79; P<0.001; NNT4.8 years=19) versus placebo. Similarly, large reductions occurred in total coronary revascularizations and revascularization subtypes. There was also a 39% reduction in total events (rate ratio, 0.61; 95% CI, 0.52-0.72; P<0.001). Conclusions Among patients treated with
statins with elevated
triglycerides and a history of prior PCI,
icosapent ethyl substantially reduced the risk of recurrent events during an average of ~5 years of follow-up with a number needed to treat of only 12. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.