TY - JOUR
T1 - Relationship between therapeutic effects on infarct size in acute myocardial infarction and therapeutic effects on 1-year outcomes: A patient-level analysis of randomized clinical trials
AU - Selker, Harry P.
AU - Udelson, James E.
AU - Ruthazer, Robin
AU - D'Agostino, Ralph B.
AU - Nichols, Melissa
AU - Ben-Yehuda, Ori
AU - Eitel, Ingo
AU - Granger, Christopher B.
AU - Jenkins, Paul
AU - Maehara, Akiko
AU - Patel, Manesh R.
AU - Ohman, E. Magnus
AU - Thiele, Holger
AU - Stone, Gregg W.
N1 - Publisher Copyright:
© 2017 Elsevier, Inc.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Background While infarct size in patients with ST-segment elevation myocardial infarction (STEMI) has been generally associated with long-term prognosis, whether a therapeutic effect on infarct size has a corresponding therapeutic effect on long-term outcomes is unknown. Methods Using combined patient-level data from 10 randomized trials of primary percutaneous coronary intervention (PCI) for STEMI, we created multivariable Cox proportional hazard models for one-year heart failure hospitalization and all-cause mortality, which included clinical features and a variable representing treatment effect on infarct size. The trials included 2679 participants; infarct size was measured at a median 4 days post infarction. Results Mean infarct size among the control groups ranged from 16% to 35% of the left ventricle, and from 12% to 36% among treatment groups. There was a significant relationship between treatment effect on infarct size and treatment effect on 1-year heart failure hospitalization (HR 0.85, 95% CI 0.77-0.93, P = .0006), but not on one-year mortality (HR 0.97, 95% CI 0.89-1.06). The treatment effect between infarct size and heart failure hospitalization was stable in sensitivity analyses adjusting for time from STEMI onset to infarct size assessment, and when considering heart failure as the main outcome and death as a competing risk. Conclusions We conclude that early treatment-induced effects on infarct size are related in direction and magnitude to treatment effects on heart failure hospitalizations. This finding enables consideration of using infarct size as a valid surrogate outcome measure in assessing new STEMI treatments.
AB - Background While infarct size in patients with ST-segment elevation myocardial infarction (STEMI) has been generally associated with long-term prognosis, whether a therapeutic effect on infarct size has a corresponding therapeutic effect on long-term outcomes is unknown. Methods Using combined patient-level data from 10 randomized trials of primary percutaneous coronary intervention (PCI) for STEMI, we created multivariable Cox proportional hazard models for one-year heart failure hospitalization and all-cause mortality, which included clinical features and a variable representing treatment effect on infarct size. The trials included 2679 participants; infarct size was measured at a median 4 days post infarction. Results Mean infarct size among the control groups ranged from 16% to 35% of the left ventricle, and from 12% to 36% among treatment groups. There was a significant relationship between treatment effect on infarct size and treatment effect on 1-year heart failure hospitalization (HR 0.85, 95% CI 0.77-0.93, P = .0006), but not on one-year mortality (HR 0.97, 95% CI 0.89-1.06). The treatment effect between infarct size and heart failure hospitalization was stable in sensitivity analyses adjusting for time from STEMI onset to infarct size assessment, and when considering heart failure as the main outcome and death as a competing risk. Conclusions We conclude that early treatment-induced effects on infarct size are related in direction and magnitude to treatment effects on heart failure hospitalizations. This finding enables consideration of using infarct size as a valid surrogate outcome measure in assessing new STEMI treatments.
UR - http://www.scopus.com/inward/record.url?scp=85015788210&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2017.02.028
DO - 10.1016/j.ahj.2017.02.028
M3 - Journal articles
C2 - 28577674
AN - SCOPUS:85015788210
SN - 0002-8703
VL - 188
SP - 18
EP - 25
JO - American Heart Journal
JF - American Heart Journal
ER -