TY - JOUR
T1 - Competing risks of cardiovascular versus noncardiovascular death during long-term follow-up after acute coronary syndromes
AU - Fanaroff, Alexander C.
AU - Roe, Matthew T.
AU - Clare, Robert M.
AU - Lokhnygina, Yuliya
AU - Navar, Ann Marie
AU - Giugliano, Robert P.
AU - Wiviott, Stephen D.
AU - Tershakovec, Andrew M.
AU - Braunwald, Eugene
AU - Blazing, Michael A.
N1 - Funding Information:
Fanaroff reports research funding through DCRI from Gilead Sciences. Roe reports research support from AstraZeneca, Eli Lilly & Co., Janssen Pharmaceuticals, Sanofi-Aventis, Daiichi-Sankyo, Familial Hypercholesterolemia Foundation, Ferring Pharmaceuticals; educational activities for Amgen and Bristol-Myers Squibb; and consulting for Eli Lilly & Co, Daiichi-Sankyo, Elsevier Publishers, Boehringer-Ingelheim, PriMed, Myokardia, AstraZeneca, Merck & Co, and Amgen. Navar reports research support from Amgen, Regeneron and Sanofi; and consulting for Amgen and Sanofi. Giugliano reports executive committee membership for the FOURIER and EBBINGHAUS studies, supported by a research grant from Amgen; research grant support to the Brigham and Women’s Hospital from Amgen and Merck; honoraria for CME lectures and/or consulting from Amgen, Daiichi-Sankyo, and Merck; and honoraria for CME lectures and/or consulting from the American College of Cardiology, Bristol-Myers Squibb, CVS Caremark, and Pfizer. Wiviott reports grant support from Merck and Sanofi-Aventis; grant support and personal fees from AstraZeneca, Bristol-Myers Squibb, Eisai, Arena, and Eli Lilly/Daiichi-Sankyo; personal fees from Aegerion, Angelmed, Janssen, Xoma, ICON Clinical, and Boston Clinical Research Institute outside the submitted work. Tershakovec reports employment by & ownership interest in Merck & Co., Inc. Braunwald reports membership of the TIMI Study Group, which has received research grant support from Amgen, Bristol-Myers Squibb, and Merck to conduct clinical trials related to lipid therapy; grant support from GlaxoSmithKline, Bristol-Myers Squibb, Duke University, AstraZeneca, and Johnson & Johnson; grant support and personal fees from Daiichi-Sankyo and Sanofi Aventis; personal fees from The Medicines Company, Menarini International, Bayer, and Medscape; and other support from Novartis. Blazing reports research support from Merck & Co and Sanofi-Aventis; educational activities for Amgen, Inc. and AstraZeneca; and consulting for Amgen, AstraZeneca, Pfizer; Merck & Co., Novartis Pharmaceutical Company, and Sanofi-Aventis. Others: The remaining authors have nothing to disclose.
Funding Information:
The IMPROVE-IT trial was supported by Merck & Co., Inc. Fanaroff is supported by NIH grant 5T32HL069749-13 and American Heart Association grant 17FTF33661087. Navar is supported by NHLBI grant K01HL133416.
Publisher Copyright:
© 2017 The Authors.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - Background--Understanding the relative risk of cardiovascular versus noncardiovascular death is important for designing clinical trials. These risks may differ depending on patient age, sex, and type of acute coronary syndrome (ACS). Methods and Results--IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) was a randomized controlled trial of simvastatin plus either ezetimibe or placebo following stabilized ACS. Cause of death was adjudicated by an independent committee. We compared the cumulative incidence of cardiovascular and noncardiovascular death for patients with unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI), in those < 65 and ≥65 years old, and males and females, over 7 years of follow-up. Of 18 131 patients, the presenting event was STEMI for 5190 (29%) and UA/NSTEMI for 12 941 (71%); 10 173 (56%) patients were < 65 years old and 7971 (44%) were ≥65 years old at presentation. UA/NSTEMI patients were older than STEMI patients, with more cardiovascular and noncardiovascular risk factors. In STEMI patients, the cumulative incidence of cardiovascular death was higher for ~4 years following the index event, after which noncardiovascular death predominated. In UA/NSTEMI patients, the cumulative incidence of cardiovascular death remained higher than noncardiovascular death over the full follow-up period. Patients ≥65 years old and < 65 years old had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up. Female patients had a higher incidence of cardiovascular death than noncardiovascular death for ~6 years following the index event; male patients had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up. Conclusions--Among post-ACS patients enrolled in a long-term clinical trial, the relative incidence of cardiovascular and noncardiovascular death differed based on type of ACS presentation and sex, but not age. These findings further delineate longterm prognosis after ACS and should inform the design of future cardiovascular outcomes trials.
AB - Background--Understanding the relative risk of cardiovascular versus noncardiovascular death is important for designing clinical trials. These risks may differ depending on patient age, sex, and type of acute coronary syndrome (ACS). Methods and Results--IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) was a randomized controlled trial of simvastatin plus either ezetimibe or placebo following stabilized ACS. Cause of death was adjudicated by an independent committee. We compared the cumulative incidence of cardiovascular and noncardiovascular death for patients with unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI), in those < 65 and ≥65 years old, and males and females, over 7 years of follow-up. Of 18 131 patients, the presenting event was STEMI for 5190 (29%) and UA/NSTEMI for 12 941 (71%); 10 173 (56%) patients were < 65 years old and 7971 (44%) were ≥65 years old at presentation. UA/NSTEMI patients were older than STEMI patients, with more cardiovascular and noncardiovascular risk factors. In STEMI patients, the cumulative incidence of cardiovascular death was higher for ~4 years following the index event, after which noncardiovascular death predominated. In UA/NSTEMI patients, the cumulative incidence of cardiovascular death remained higher than noncardiovascular death over the full follow-up period. Patients ≥65 years old and < 65 years old had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up. Female patients had a higher incidence of cardiovascular death than noncardiovascular death for ~6 years following the index event; male patients had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up. Conclusions--Among post-ACS patients enrolled in a long-term clinical trial, the relative incidence of cardiovascular and noncardiovascular death differed based on type of ACS presentation and sex, but not age. These findings further delineate longterm prognosis after ACS and should inform the design of future cardiovascular outcomes trials.
KW - Acute coronary syndrome
KW - Clinical trial
KW - Death
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U2 - 10.1161/JAHA.117.005840
DO - 10.1161/JAHA.117.005840
M3 - Article
C2 - 28923989
AN - SCOPUS:85029754205
VL - 6
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
SN - 2047-9980
IS - 9
M1 - e005840
ER -