학술논문
Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG.
Document Type
Academic Journal
Author
Verma S; Montreal Heart Institute, Université de Montréal, Quebec, Canada (J-C.T.).; Bhatt DL; Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B., R.P.G.).; Steg PG; Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, French Alliance for Cardiovascular Trials, and Institut National de la Santé et de la Recherche Médicale U-1148, Paris, France (P.G.S.).; Miller M; Department of Medicine, University of Maryland School of Medicine, Baltimore (M.M.).; Brinton EA; Utah Lipid Center, Salt Lake City (E.A.B.).; Jacobson TA; Office of Health Promotion and Disease Prevention, Department of Medicine, Emory University School of Medicine, Atlanta, GA (T.A.J.).; Dhingra NK; Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, ON, Canada (S.V., N.K.D.).; Ketchum SB; Amarin Pharma Inc, Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).; Juliano RA; Amarin Pharma Inc, Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).; Jiao L; Amarin Pharma Inc, Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).; Doyle RT Jr; Amarin Pharma Inc, Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).; Granowitz C; Amarin Pharma Inc, Bridgewater, NJ (S.B.K., R.A.J., L.J., R.T.D., C.G.).; Gibson CM; Baim Clinical Research Institute, Boston, MA (C.M.G., D.P.).; Pinto D; Baim Clinical Research Institute, Boston, MA (C.M.G., D.P.).; Giugliano RP; Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B., R.P.G.).; Budoff MJ; David Geffen School of Medicine, Lundquist Institute, Torrance, CA (M.J.B.).; Mason RP; Elucida Research, Beverly, MA (R.P.M.).; Tardif JC; Montreal Heart Institute, Université de Montréal, Quebec, Canada (J-C.T.).; Ballantyne CM; Department of Medicine, Baylor College of Medicine, and Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (C.M.B.).
Source
Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0147763 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1524-4539 (Electronic) Linking ISSN: 00097322 NLM ISO Abbreviation: Circulation Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk after coronary artery bypass grafting surgery.
Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting.
Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63-0.92]; P =0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56-0.87]; P =0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50-0.81]; P =0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%-10.2%) in first events, with a number needed to treat of 16 (95% CI, 10-44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P =0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups.
Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.
Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting.
Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63-0.92]; P =0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56-0.87]; P =0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50-0.81]; P =0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%-10.2%) in first events, with a number needed to treat of 16 (95% CI, 10-44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P =0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups.
Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.