Fabien Picard1, Deepak L Bhatt2, Grégory Ducrocq3, E Magnus Ohman4, Shinya Goto5, Kim A Eagle6, Peter W F Wilson7, Sidney C Smith8, Yedid Elbez9, Philippe Gabriel Steg10. 1. FACT (French Alliance for Cardiovascular Trials), Paris, France; Cardiology Department, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France. 2. Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA, USA. 3. FACT (French Alliance for Cardiovascular Trials), Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, and INSERM U1148, Paris, France; Université de Paris, Paris, France. 4. Duke University Medical Center, Durham, NC, USA. 5. Department of Medicine, Tokai University School of Medicine, Isehara, Japan. 6. University of Michigan Health System, Ann Arbor, MI, USA. 7. Atlanta VA Medical Center and Emory Cardiovascular Research Institute, GA, USA. 8. Heart and Vascular Center, University of North Carolina at Chapel Hill, NC, USA. 9. FACT (French Alliance for Cardiovascular Trials), Paris, France. 10. FACT (French Alliance for Cardiovascular Trials), Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, and INSERM U1148, Paris, France; Université de Paris, Paris, France; NHLI Imperial College, ICMS, Royal Brompton Hospital, London, United Kingdom. Electronic address: gabriel.steg@aphp.fr.
Abstract
BACKGROUND: The REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) trial demonstrated that high-dose icosapent-ethyl reduced the risk of ischemic events in statin-treated patients with elevated triglycerides (TG) and either atherosclerotic cardiovascular disease (ASCVD) or diabetes plus at least one risk factor. METHODS AND RESULTS: Using data from REACH (Reduction of Atherothrombosis for Continued Health), a large international registry of outpatients with or at risk of ASCVD, we evaluated the proportion of patients potentially eligible for enrolment in REDUCE-IT and compared their outcomes to those excluded because of low TG. Among 62,464 patients with either ASCVD or diabetes enrolled in the REACH Registry, 1036/8418 (12.3%) patients in primary prevention and 6049/54046 (11.2%) patients in secondary prevention (11.3% overall) would have been eligible for inclusion in REDUCE-IT. Compared with patients excluded for low TG level, adjusted risk of the primary composite outcome of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, unstable angina, or coronary revascularization was higher in the REDUCE-IT eligible group (HR:1.06, 95%CI:1.00-1.13, p = 0.04). In addition, unstable angina, non-fatal MI, percutaneous coronary intervention and coronary artery bypass grafting were also more frequent in the REDUCE-IT eligible group (HR:1.17, 95%CI:1.07-1.27, p < 0.001; HR:1.25, 95%CI:1.07-1.45, p < 0.001; HR:1.42, 95%CI:1.27-1.57, p < 0.001; HR:1.43, 95%CI:1.19-1.71, p < 0.001, respectively), whereas the adjusted risk of non-fatal stroke was lower (HR:0.64, 95%CI:0.54-0.75, p < 0.001). CONCLUSION: In this large international registry of patients with or at high-risk of ASCVD, 11.3% met the REDUCE-IT trial selection criteria. REDUCE-IT eligible patients were found to be at higher risk of cardiac atherothrombotic events, but at lower risk of stroke than trial-ineligible patients with lower TG.
BACKGROUND: The REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial) trial demonstrated that high-dose icosapent-ethyl reduced the risk of ischemic events in statin-treated patients with elevated triglycerides (TG) and either atherosclerotic cardiovascular disease (ASCVD) or diabetes plus at least one risk factor. METHODS AND RESULTS: Using data from REACH (Reduction of Atherothrombosis for Continued Health), a large international registry of outpatients with or at risk of ASCVD, we evaluated the proportion of patients potentially eligible for enrolment in REDUCE-IT and compared their outcomes to those excluded because of low TG. Among 62,464 patients with either ASCVD or diabetes enrolled in the REACH Registry, 1036/8418 (12.3%) patients in primary prevention and 6049/54046 (11.2%) patients in secondary prevention (11.3% overall) would have been eligible for inclusion in REDUCE-IT. Compared with patients excluded for low TG level, adjusted risk of the primary composite outcome of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, unstable angina, or coronary revascularization was higher in the REDUCE-IT eligible group (HR:1.06, 95%CI:1.00-1.13, p = 0.04). In addition, unstable angina, non-fatal MI, percutaneous coronary intervention and coronary artery bypass grafting were also more frequent in the REDUCE-IT eligible group (HR:1.17, 95%CI:1.07-1.27, p < 0.001; HR:1.25, 95%CI:1.07-1.45, p < 0.001; HR:1.42, 95%CI:1.27-1.57, p < 0.001; HR:1.43, 95%CI:1.19-1.71, p < 0.001, respectively), whereas the adjusted risk of non-fatal stroke was lower (HR:0.64, 95%CI:0.54-0.75, p < 0.001). CONCLUSION: In this large international registry of patients with or at high-risk of ASCVD, 11.3% met the REDUCE-IT trial selection criteria. REDUCE-IT eligible patients were found to be at higher risk of cardiac atherothrombotic events, but at lower risk of stroke than trial-ineligible patients with lower TG.
Authors: Catherine G Derington; Adam P Bress; Jennifer S Herrick; Wenjun Fan; Nathan D Wong; Katherine E Andrade; Jonathan Johnson; Sephy Philip; David Abrahamson; Lixia Jiao; Deepak L Bhatt; William S Weintraub Journal: Am J Prev Cardiol Date: 2022-04-28
Authors: Benjamin E Peterson; Deepak L Bhatt; Ph Gabriel Steg; Michael Miller; Eliot A Brinton; Terry A Jacobson; Steven B Ketchum; Rebecca A Juliano; Lixia Jiao; Ralph T Doyle; Craig Granowitz; C Michael Gibson; Duane Pinto; Robert P Giugliano; Matthew J Budoff; Jean-Claude Tardif; Subodh Verma; Christie M Ballantyne Journal: J Am Heart Assoc Date: 2022-03-09 Impact factor: 6.106