TY - JOUR
T1 - Definitions of periprocedural myocardial infarction as surrogates for catheterization laboratory quality or clinical trial end points
AU - Baker, Nevin C.
AU - Lipinski, Michael J.
AU - Escarcega, Ricardo O.
AU - Magalhaes, Marco A.
AU - Minha, Sa'Ar
AU - Torguson, Rebecca
AU - Waksman, Ron
PY - 2014/4/15
Y1 - 2014/4/15
N2 - A consensus on what constitutes a clinically meaningful periprocedural myocardial infarction (PMI) remains highly debated. We evaluated the accuracy of 2 PMI definitions currently implemented for quality outcome assessment and clinical trial end points. Patients who underwent elective percutaneous coronary intervention with normal baseline troponin-I and creatine kinase-MB were included. PMI was defined according to either the 2007 Task Force (National Cardiovascular Database Registry [NCDR] CathPCI Registry) definition or the updated 2012 Task Force definition. Multivariate analysis was performed for the end point of 1-year all-cause death or myocardial infarction (MI). Of the 7,333 patients included, 31.9% and 2.1% were identified as having a PMI by NCDR or 2012 definition, respectively. Mean age was 66 ± 11 years; 66.8% were men, 1.4 ± 0.9 stents implanted per patient, 84.5% bivalirudin use, and 29.7 type C lesions. Death or MI occurred in 5.6% of NCDR and 6.6% of 2012 defined patients. Neither biomarker was independently associated with death or MI for either definition (NCDR odds ratio 1.1, 95% confidence interval 0.9 to 1.5, p = 0.34; 2012 Task Force odds ratio 1.4, 95% confidence interval 0.7 to 3.0, p = 0.38). Only a modest correlation exists for either definition to predict death or MI, which did not improve for the 2012 definition. In conclusion, PMI definitions currently used for catheterization lab quality metrics and those used for clinical trial end points have poor discrimination for adverse events. Although the 2012 definition drastically reduced the number of PMIs defined, it did not decrease the predictive accuracy over the NCDR definition.
AB - A consensus on what constitutes a clinically meaningful periprocedural myocardial infarction (PMI) remains highly debated. We evaluated the accuracy of 2 PMI definitions currently implemented for quality outcome assessment and clinical trial end points. Patients who underwent elective percutaneous coronary intervention with normal baseline troponin-I and creatine kinase-MB were included. PMI was defined according to either the 2007 Task Force (National Cardiovascular Database Registry [NCDR] CathPCI Registry) definition or the updated 2012 Task Force definition. Multivariate analysis was performed for the end point of 1-year all-cause death or myocardial infarction (MI). Of the 7,333 patients included, 31.9% and 2.1% were identified as having a PMI by NCDR or 2012 definition, respectively. Mean age was 66 ± 11 years; 66.8% were men, 1.4 ± 0.9 stents implanted per patient, 84.5% bivalirudin use, and 29.7 type C lesions. Death or MI occurred in 5.6% of NCDR and 6.6% of 2012 defined patients. Neither biomarker was independently associated with death or MI for either definition (NCDR odds ratio 1.1, 95% confidence interval 0.9 to 1.5, p = 0.34; 2012 Task Force odds ratio 1.4, 95% confidence interval 0.7 to 3.0, p = 0.38). Only a modest correlation exists for either definition to predict death or MI, which did not improve for the 2012 definition. In conclusion, PMI definitions currently used for catheterization lab quality metrics and those used for clinical trial end points have poor discrimination for adverse events. Although the 2012 definition drastically reduced the number of PMIs defined, it did not decrease the predictive accuracy over the NCDR definition.
UR - http://www.scopus.com/inward/record.url?scp=84897428492&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2014.01.408
DO - 10.1016/j.amjcard.2014.01.408
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C2 - 24576542
AN - SCOPUS:84897428492
SN - 0002-9149
VL - 113
SP - 1326
EP - 1330
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 8
ER -