Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE‐IT PCI

Author:

Peterson Benjamin E.1ORCID,Bhatt Deepak L.1ORCID,Steg Ph. Gabriel2ORCID,Miller Michael3ORCID,Brinton Eliot A.4ORCID,Jacobson Terry A.5ORCID,Ketchum Steven B.6ORCID,Juliano Rebecca A.6ORCID,Jiao Lixia6ORCID,Doyle Ralph T.6ORCID,Granowitz Craig6,Gibson C. Michael7,Pinto Duane7ORCID,Giugliano Robert P.1ORCID,Budoff Matthew J.8ORCID,Tardif Jean‐Claude9ORCID,Verma Subodh10ORCID,Ballantyne Christie M.11ORCID,

Affiliation:

1. Brigham and Women’s Hospital Heart and Vascular Center Harvard Medical School Boston MA

2. Université de ParisAP‐HP (Assistance Publique‐Hôpitaux de Paris)Hôpital BichatFACT (French Alliance for Cardiovascular Trials)INSERM U‐1148 Paris France

3. Department of Medicine University of Maryland School of Medicine Baltimore MD

4. Utah Lipid Center Salt Lake City UT

5. Department of Medicine Office of Health Promotion and Disease Prevention Emory University School of Medicine Atlanta GA

6. Amarin Pharma, Inc. (Amarin) Bridgewater NJ

7. Baim Clinical Research Institute Boston MA

8. David Geffen School of Medicine Lundquist Institute Torrance CA

9. Montreal Heart InstituteUniversité de Montréal Quebec Canada

10. Division of Cardiac Surgery St Michael’s HospitalUniversity of Toronto Ontario Canada

11. Department of Medicine Baylor College of MedicineCenter for Cardiovascular Disease PreventionMethodist DeBakey Heart and Vascular Center Houston TX

Abstract

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 treat 4.8 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; NNT 4.8 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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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