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2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards) | Journal Scan
- Authors:
- Hicks KA, Tcheng JE, Bozkurt B, et al.
- Citation:
- J Am Coll Cardiol 2014;Dec 29:[Epub ahead of print].
The following are 10 points to remember about this data standards document on cardiovascular endpoint events in clinical trials:
1. The key elements and definitions are intended to facilitate the consistent, accurate, and reproducible capture of clinical concepts; standardize the terminology used to describe cardiovascular diseases and procedures; create a data environment conducive to the assessment of patient management and outcomes for quality and performance improvement and clinical and translational research; and increase opportunities for sharing data across disparate data sources.
2. Death is classified into the following three categories: 1) cardiovascular death, 2) noncardiovascular death, and 3) undetermined cause of death. The intent of the classification schema is to identify one, and only one, of the categories as the underlying cause of death. The key priority is differentiating between cardiovascular and noncardiovascular causes of death. The suggested subcategories for attribution of death to a cardiovascular etiology are acute myocardial infarction, sudden cardiac death, heart failure (HF), stroke, cardiovascular procedure, cardiovascular hemorrhage, and other cardiovascular causes.
3. The key recommendation is to base thresholds for biomarker detection of myocardial infarction on 99th percentile values (i.e., the upper reference limit) rather than on ‘upper limit of normal’ values. Multiple assays exist for cardiac troponin and the MB fraction of creatine kinase (CK-MB), and assay characteristics vary by manufacturer. Some assays reported by local laboratories provide the 99th percentile and a higher ‘decision limit’ or ‘upper limit of normal’ above which myocardial infarction should be considered. The Third Universal Definition of Myocardial Infarction recommends the use of the 99th percentile upper reference limit as the reference standard.
4. The terminology set for unstable angina focuses on data elements needed for determining whether symptoms truly represent cardiovascular ischemia, including the character and duration of the presenting symptoms, the proximity of symptom onset to hospitalization, and the duration of hospitalization. Electrocardiographic abnormalities are pivotal to the diagnosis.
5. The Writing Committee proposes the following definition of transient ischemic attack (TIA): ‘a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.’ This definition is identical to that adopted by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) (Food and Drug Administration [FDA] Stroke Team) and is based on one previously proposed in a Scientific Statement of the American Heart Association (AHA) and American Stroke Association (ASA) with one subtle, but important difference. As defined by the AHA/ASA Scientific Statement, TIA is ‘a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.’ The SCTI’s definition that the Writing Committee has adopted emphasizes the clinical presentation rather than the anatomic location of the TIA, and may be more appropriate for clinical trial use because the availability of imaging modalities may vary greatly from one study center to the next.
6. The proposed HF endpoint event has been constructed independently of whether the exacerbation of HF results in hospitalization, recognizing that HF exacerbation can often be managed on an outpatient basis such as with an urgent or unscheduled outpatient office/practice or emergency room visit. Instead, the key characteristic of an HF event is the need for a resource-intensive response to failure of the primary therapeutic management strategy.
7. The terminology set for percutaneous coronary intervention (PCI) concentrates on PCI status, procedural success, target lesion failure, target lesion revascularization, and both intraprocedural and vascular complications.
8. Although vascular disease is defined as ‘all diseases of the arteries, veins, and lymphatic vessels,’ for simplicity, this vocabulary for peripheral vascular intervention endpoints focuses on data elements that describe revascularization interventions involving the peripheral arterial circulation. These data standards concentrate on peripheral arterial disease involving the infrarenal aorta, iliac, and infrainguinal arteries, and carotid, renal, mesenteric, and aortic interventions.
9. The terminology set focuses on data elements required for confirmation of stent thrombosis. To classify these events accordingly, the following information is required: clinical details surrounding the acute event; dates and procedural information for all prior stent procedures; serial electrocardiograms at the time of the event and for appropriate duration of follow-up; serial cardiac biomarkers; results of coronary angiography with review by an independent angiographic core laboratory or independent clinical events committee; and clinical details surrounding all deaths, including death certificate and autopsy report, if applicable.
10. The endpoint concepts will be represented in the National Institutes of Health/National Cancer Institute Data Standards Registry and Repository to facilitate the use of the terminology set across the clinical care, research, and regulatory domains. The Writing Committee acknowledges that cardiovascular and stroke endpoint event concepts are a subset of a larger set of cardiovascular endpoints. In particular, additional concepts such as those describing carotid/cerebral revascularization, peripheral surgical revascularization, aortic dissection, abdominal aortic aneurysm, aortic surgery, and valvular heart disease remain to be developed.
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1. The key elements and definitions are intended to facilitate the consistent, accurate, and reproducible capture of clinical concepts; standardize the terminology used to describe cardiovascular diseases and procedures; create a data environment conducive to the assessment of patient management and outcomes for quality and performance improvement and clinical and translational research; and increase opportunities for sharing data across disparate data sources.
2. Death is classified into the following three categories: 1) cardiovascular death, 2) noncardiovascular death, and 3) undetermined cause of death. The intent of the classification schema is to identify one, and only one, of the categories as the underlying cause of death. The key priority is differentiating between cardiovascular and noncardiovascular causes of death. The suggested subcategories for attribution of death to a cardiovascular etiology are acute myocardial infarction, sudden cardiac death, heart failure (HF), stroke, cardiovascular procedure, cardiovascular hemorrhage, and other cardiovascular causes.
3. The key recommendation is to base thresholds for biomarker detection of myocardial infarction on 99th percentile values (i.e., the upper reference limit) rather than on ‘upper limit of normal’ values. Multiple assays exist for cardiac troponin and the MB fraction of creatine kinase (CK-MB), and assay characteristics vary by manufacturer. Some assays reported by local laboratories provide the 99th percentile and a higher ‘decision limit’ or ‘upper limit of normal’ above which myocardial infarction should be considered. The Third Universal Definition of Myocardial Infarction recommends the use of the 99th percentile upper reference limit as the reference standard.
4. The terminology set for unstable angina focuses on data elements needed for determining whether symptoms truly represent cardiovascular ischemia, including the character and duration of the presenting symptoms, the proximity of symptom onset to hospitalization, and the duration of hospitalization. Electrocardiographic abnormalities are pivotal to the diagnosis.
5. The Writing Committee proposes the following definition of transient ischemic attack (TIA): ‘a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.’ This definition is identical to that adopted by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) (Food and Drug Administration [FDA] Stroke Team) and is based on one previously proposed in a Scientific Statement of the American Heart Association (AHA) and American Stroke Association (ASA) with one subtle, but important difference. As defined by the AHA/ASA Scientific Statement, TIA is ‘a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.’ The SCTI’s definition that the Writing Committee has adopted emphasizes the clinical presentation rather than the anatomic location of the TIA, and may be more appropriate for clinical trial use because the availability of imaging modalities may vary greatly from one study center to the next.
6. The proposed HF endpoint event has been constructed independently of whether the exacerbation of HF results in hospitalization, recognizing that HF exacerbation can often be managed on an outpatient basis such as with an urgent or unscheduled outpatient office/practice or emergency room visit. Instead, the key characteristic of an HF event is the need for a resource-intensive response to failure of the primary therapeutic management strategy.
7. The terminology set for percutaneous coronary intervention (PCI) concentrates on PCI status, procedural success, target lesion failure, target lesion revascularization, and both intraprocedural and vascular complications.
8. Although vascular disease is defined as ‘all diseases of the arteries, veins, and lymphatic vessels,’ for simplicity, this vocabulary for peripheral vascular intervention endpoints focuses on data elements that describe revascularization interventions involving the peripheral arterial circulation. These data standards concentrate on peripheral arterial disease involving the infrarenal aorta, iliac, and infrainguinal arteries, and carotid, renal, mesenteric, and aortic interventions.
9. The terminology set focuses on data elements required for confirmation of stent thrombosis. To classify these events accordingly, the following information is required: clinical details surrounding the acute event; dates and procedural information for all prior stent procedures; serial electrocardiograms at the time of the event and for appropriate duration of follow-up; serial cardiac biomarkers; results of coronary angiography with review by an independent angiographic core laboratory or independent clinical events committee; and clinical details surrounding all deaths, including death certificate and autopsy report, if applicable.
10. The endpoint concepts will be represented in the National Institutes of Health/National Cancer Institute Data Standards Registry and Repository to facilitate the use of the terminology set across the clinical care, research, and regulatory domains. The Writing Committee acknowledges that cardiovascular and stroke endpoint event concepts are a subset of a larger set of cardiovascular endpoints. In particular, additional concepts such as those describing carotid/cerebral revascularization, peripheral surgical revascularization, aortic dissection, abdominal aortic aneurysm, aortic surgery, and valvular heart disease remain to be developed.
Keywords: American Heart Association, Angina, Unstable, Biomarkers, Brain, Cause of Death, Coronary Angiography, Creatine Kinase, Death Certificates, Death, Sudden, Cardiac, Electrocardiography, Emergency Service, Hospital, Heart Failure, Hospitalization, Ischemic Attack, Transient, Myocardial Infarction, Percutaneous Coronary Intervention, Peripheral Arterial Disease, Registries, Spinal Cord, Stents, Stroke, Thrombosis, Translational Medical Research, Troponin, United States Food and Drug Administration
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