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AMSTERDAM – An early rule-out strategy based upon using two cardiac biomarkers allowed for safe discharge within a couple hours from the emergency department for most low- to intermediate-risk patients who presented with suspected acute coronary syndrome, based on the results of a randomized, multicenter trial conducted in Europe.
Moreover, the 30-day rates of major adverse cardiovascular events in the Biomarkers in Cardiology-8 (BiC-8) study were similarly low in patients discharged from the ED using the early rule-out process and in those who received standard, guideline-recommended care, which includes 6-12 hours of serial ECGs and troponin measurements in the chest pain unit, Dr. Martin Moeckel reported at the annual congress of the European Society of Cardiology.
"This biomarker strategy using a state-of-the-art quantitative troponin assay in combination with an ultrasensitive copeptin assay has the potential to change clinical practice with high patient safety," observed Dr. Moeckel of Charité Hospital, Berlin. The copeptin test is approved for use in the European Union but remains investigational in the United States.
Based upon the results of BiC-8, this dual biomarker for early rule-out of myocardial infarction (MI) is now standard clinical practice at Charité, he added.
The rationale for developing the early rule-out strategy tested in BiC-8 lies in the serious overcrowding that is now the norm in many EDs. This overcrowding has been shown to be in and of itself a risk factor for poor outcomes. The quandary is that nearly 12% of all patients who present to the ED do so because of chest pain, yet after an extensive and time-consuming evaluation only 1 in 10 of those patients is found to actually be having an acute MI.
"Rapid rule-out of acute MI is therefore a major clinical need, saving the health care system time and resources, and saving patients unnecessary stress, anxiety, and other risks," he said.
Copeptin is a marker for vasopressin, a hemodynamic stress indicator that shoots up immediately in an acute MI. In earlier studies, a negative result for both troponin and copeptin in an initial blood sample drawn at ED presentation had a 99% negative predictive value for MI.
The BiC-8 trial included 902 low- to intermediate-risk patients who presented with suspected acute coronary syndrome (ACS) to EDs in university medical centers. All had a negative initial cardiac troponin test. They were randomized to standard care in the chest pain unit, including serial troponin testing and ECGs, or to the experimental strategy, in which physicians were informed of the copeptin results from the same initial blood sample as the troponin. If the copeptin test was positive as defined by a level of 10 pmol/L or more, the patient was hospitalized for standard care. If the copeptin result was negative, however, the patient was immediately discharged with a scheduled outpatient visit within 72 hours.
Of the patients in the copeptin group, 66% were discharged directly from the ED, compared with 12% in the standard-care group.
The 30-day incidence of major adverse cardiovascular events (MACE) was 5.5% in the standard-care group and nearly identical at 5.46% in the copeptin group. However, physicians were permitted under the study protocol to overrule negative biomarker test results on the basis of their final clinical assessment, such as if their suspicions were aroused due to recurrent symptoms or new information about the patient’s history. In this per-protocol analysis, the 30-day MACE rate was 5.68% in the standard-care group and 3.18% in the copeptin group.
MACE was defined in BiC-8 as all-cause mortality, MI, rehospitalization for ACS, acute unplanned percutaneous coronary intervention (PCI), coronary artery bypass surgery, life-threatening arrhythmia, or resuscitation from cardiac arrest.
MACE occurred in 14 copeptin-negative patients. However, 12 of the 14 were not discharged early because physicians overruled the negative biomarker results and moved the patients into standard in-hospital management. Two patients, or 0.6% of those discharged from the ED on the basis of a negative copeptin test had adverse events: One was rehospitalized on day 23 and underwent acute unplanned PCI on the next day, and the other was rehospitalized on day 4 and underwent coronary artery bypass graft surgery on day 12.
American Heart Association Immediate Past President Donna K. Arnett, Ph.D., said in an interview that she’d really like to see a second, confirmatory randomized trial before this early rule-out strategy is widely adopted. She considers the lost-to-follow-up rate uncomfortably high: 63 patients in the intention-to-treat analysis, and another 75 not accounted for in the per-protocol analysis, noted Dr. Arnett, professor and chair of the epidemiology department at the University of Alabama, Birmingham.
BiC-8 coinvestigator Dr. Kurt Huber said in an interview that the dual-biomarker early rule-out strategy is now used routinely in the hospital where he practices. Yet like Dr. Arnett, he considers a confirmatory test "extremely important" before concluding that the strategy is ready for prime-time use in every ED.
"The most important message from BiC-8, I think, is that these were patients at low to intermediate risk; they’re not the high-risk patients. And it’s also important that the physician doesn’t rely only on the test result, but also takes a final look at the clinical situation before releasing the patient. There is some overruling when patients are biomarker-negative but have typical risk markers. No test is 100% accurate. Clinical judgment remains extremely important," emphasized Dr. Huber, professor and director of cardiology and emergency medicine at Wilhelminen Hospital, Vienna.
The BiC-8 trial was sponsored by ThermoFisher Scientific and six university medical centers in German-speaking Europe. Dr. Moeckel reported receiving a research grant from ThermoFisher and serving as a consultant to Bayer, AstraZeneca, and The Medicines Company. Dr. Arnett and Dr. Huber had no conflicts of interest to declare.
In an era of tight resource utilization, patient throughput problems with ED backlogs, and judicious placement of higher-acuity patients into the hospital, a risk-stratification system for acute coronary syndrome (ACS) that would allow for early discharge from the ED with outpatient follow-up rather than the current practice of an extended ED workup for two troponins 6 hours apart or hospital admission, has the potential to radically change care processes.
Hospitals have developed observation units to address the need to provide less-intensive services in these clinical situations, but these units have faced significant patient concerns due to higher copays for services provided that are billed by outpatient codes.
 |
| Dr. Hiren Shah |
This study, using the novel biomarker called copeptin in addition to troponin, has shown equivalent 30-day incidence of major cardiovascular events when the early-discharge strategy is compared to current practice. I would note, however, that this assay was utilized only in low- to intermediate-risk patients, and that clinical assessment of cardiovascular risk should always supersede this new assay in the discharge decision-making process. Of course, the challenges in the determination of risk and the variability in individual physician clinical risk-assessment approaches remain significant barriers no matter which assay system is used.
Future larger studies and those with a lower lost-to-follow-up rate than the current one will yield important results that may better evaluate the copeptin assay. If the results are similar in a more thorough study, the potential to change clinical practice for our ACS patients and to affect hospital resource utilization remains very significant.
Dr. Hiren Shah is an assistant professor of medicine in the Feinberg School of Medicine, Northwestern University, Chicago, and a medical director of the Medicine and Cardiac Telemetry Hospitalist Unit at Northwestern Memorial Hospital. He is on the advisory board of Hospitalist News.
In an era of tight resource utilization, patient throughput problems with ED backlogs, and judicious placement of higher-acuity patients into the hospital, a risk-stratification system for acute coronary syndrome (ACS) that would allow for early discharge from the ED with outpatient follow-up rather than the current practice of an extended ED workup for two troponins 6 hours apart or hospital admission, has the potential to radically change care processes.
Hospitals have developed observation units to address the need to provide less-intensive services in these clinical situations, but these units have faced significant patient concerns due to higher copays for services provided that are billed by outpatient codes.
|
| Dr. Hiren Shah |
This study, using the novel biomarker called copeptin in addition to troponin, has shown equivalent 30-day incidence of major cardiovascular events when the early-discharge strategy is compared to current practice. I would note, however, that this assay was utilized only in low- to intermediate-risk patients, and that clinical assessment of cardiovascular risk should always supersede this new assay in the discharge decision-making process. Of course, the challenges in the determination of risk and the variability in individual physician clinical risk-assessment approaches remain significant barriers no matter which assay system is used.
Future larger studies and those with a lower lost-to-follow-up rate than the current one will yield important results that may better evaluate the copeptin assay. If the results are similar in a more thorough study, the potential to change clinical practice for our ACS patients and to affect hospital resource utilization remains very significant.
Dr. Hiren Shah is an assistant professor of medicine in the Feinberg School of Medicine, Northwestern University, Chicago, and a medical director of the Medicine and Cardiac Telemetry Hospitalist Unit at Northwestern Memorial Hospital. He is on the advisory board of Hospitalist News.
In an era of tight resource utilization, patient throughput problems with ED backlogs, and judicious placement of higher-acuity patients into the hospital, a risk-stratification system for acute coronary syndrome (ACS) that would allow for early discharge from the ED with outpatient follow-up rather than the current practice of an extended ED workup for two troponins 6 hours apart or hospital admission, has the potential to radically change care processes.
Hospitals have developed observation units to address the need to provide less-intensive services in these clinical situations, but these units have faced significant patient concerns due to higher copays for services provided that are billed by outpatient codes.
|
| Dr. Hiren Shah |
This study, using the novel biomarker called copeptin in addition to troponin, has shown equivalent 30-day incidence of major cardiovascular events when the early-discharge strategy is compared to current practice. I would note, however, that this assay was utilized only in low- to intermediate-risk patients, and that clinical assessment of cardiovascular risk should always supersede this new assay in the discharge decision-making process. Of course, the challenges in the determination of risk and the variability in individual physician clinical risk-assessment approaches remain significant barriers no matter which assay system is used.
Future larger studies and those with a lower lost-to-follow-up rate than the current one will yield important results that may better evaluate the copeptin assay. If the results are similar in a more thorough study, the potential to change clinical practice for our ACS patients and to affect hospital resource utilization remains very significant.
Dr. Hiren Shah is an assistant professor of medicine in the Feinberg School of Medicine, Northwestern University, Chicago, and a medical director of the Medicine and Cardiac Telemetry Hospitalist Unit at Northwestern Memorial Hospital. He is on the advisory board of Hospitalist News.
AMSTERDAM – An early rule-out strategy based upon using two cardiac biomarkers allowed for safe discharge within a couple hours from the emergency department for most low- to intermediate-risk patients who presented with suspected acute coronary syndrome, based on the results of a randomized, multicenter trial conducted in Europe.
Moreover, the 30-day rates of major adverse cardiovascular events in the Biomarkers in Cardiology-8 (BiC-8) study were similarly low in patients discharged from the ED using the early rule-out process and in those who received standard, guideline-recommended care, which includes 6-12 hours of serial ECGs and troponin measurements in the chest pain unit, Dr. Martin Moeckel reported at the annual congress of the European Society of Cardiology.
"This biomarker strategy using a state-of-the-art quantitative troponin assay in combination with an ultrasensitive copeptin assay has the potential to change clinical practice with high patient safety," observed Dr. Moeckel of Charité Hospital, Berlin. The copeptin test is approved for use in the European Union but remains investigational in the United States.
Based upon the results of BiC-8, this dual biomarker for early rule-out of myocardial infarction (MI) is now standard clinical practice at Charité, he added.
The rationale for developing the early rule-out strategy tested in BiC-8 lies in the serious overcrowding that is now the norm in many EDs. This overcrowding has been shown to be in and of itself a risk factor for poor outcomes. The quandary is that nearly 12% of all patients who present to the ED do so because of chest pain, yet after an extensive and time-consuming evaluation only 1 in 10 of those patients is found to actually be having an acute MI.
"Rapid rule-out of acute MI is therefore a major clinical need, saving the health care system time and resources, and saving patients unnecessary stress, anxiety, and other risks," he said.
Copeptin is a marker for vasopressin, a hemodynamic stress indicator that shoots up immediately in an acute MI. In earlier studies, a negative result for both troponin and copeptin in an initial blood sample drawn at ED presentation had a 99% negative predictive value for MI.
The BiC-8 trial included 902 low- to intermediate-risk patients who presented with suspected acute coronary syndrome (ACS) to EDs in university medical centers. All had a negative initial cardiac troponin test. They were randomized to standard care in the chest pain unit, including serial troponin testing and ECGs, or to the experimental strategy, in which physicians were informed of the copeptin results from the same initial blood sample as the troponin. If the copeptin test was positive as defined by a level of 10 pmol/L or more, the patient was hospitalized for standard care. If the copeptin result was negative, however, the patient was immediately discharged with a scheduled outpatient visit within 72 hours.
Of the patients in the copeptin group, 66% were discharged directly from the ED, compared with 12% in the standard-care group.
The 30-day incidence of major adverse cardiovascular events (MACE) was 5.5% in the standard-care group and nearly identical at 5.46% in the copeptin group. However, physicians were permitted under the study protocol to overrule negative biomarker test results on the basis of their final clinical assessment, such as if their suspicions were aroused due to recurrent symptoms or new information about the patient’s history. In this per-protocol analysis, the 30-day MACE rate was 5.68% in the standard-care group and 3.18% in the copeptin group.
MACE was defined in BiC-8 as all-cause mortality, MI, rehospitalization for ACS, acute unplanned percutaneous coronary intervention (PCI), coronary artery bypass surgery, life-threatening arrhythmia, or resuscitation from cardiac arrest.
MACE occurred in 14 copeptin-negative patients. However, 12 of the 14 were not discharged early because physicians overruled the negative biomarker results and moved the patients into standard in-hospital management. Two patients, or 0.6% of those discharged from the ED on the basis of a negative copeptin test had adverse events: One was rehospitalized on day 23 and underwent acute unplanned PCI on the next day, and the other was rehospitalized on day 4 and underwent coronary artery bypass graft surgery on day 12.
American Heart Association Immediate Past President Donna K. Arnett, Ph.D., said in an interview that she’d really like to see a second, confirmatory randomized trial before this early rule-out strategy is widely adopted. She considers the lost-to-follow-up rate uncomfortably high: 63 patients in the intention-to-treat analysis, and another 75 not accounted for in the per-protocol analysis, noted Dr. Arnett, professor and chair of the epidemiology department at the University of Alabama, Birmingham.
BiC-8 coinvestigator Dr. Kurt Huber said in an interview that the dual-biomarker early rule-out strategy is now used routinely in the hospital where he practices. Yet like Dr. Arnett, he considers a confirmatory test "extremely important" before concluding that the strategy is ready for prime-time use in every ED.
"The most important message from BiC-8, I think, is that these were patients at low to intermediate risk; they’re not the high-risk patients. And it’s also important that the physician doesn’t rely only on the test result, but also takes a final look at the clinical situation before releasing the patient. There is some overruling when patients are biomarker-negative but have typical risk markers. No test is 100% accurate. Clinical judgment remains extremely important," emphasized Dr. Huber, professor and director of cardiology and emergency medicine at Wilhelminen Hospital, Vienna.
The BiC-8 trial was sponsored by ThermoFisher Scientific and six university medical centers in German-speaking Europe. Dr. Moeckel reported receiving a research grant from ThermoFisher and serving as a consultant to Bayer, AstraZeneca, and The Medicines Company. Dr. Arnett and Dr. Huber had no conflicts of interest to declare.
AMSTERDAM – An early rule-out strategy based upon using two cardiac biomarkers allowed for safe discharge within a couple hours from the emergency department for most low- to intermediate-risk patients who presented with suspected acute coronary syndrome, based on the results of a randomized, multicenter trial conducted in Europe.
Moreover, the 30-day rates of major adverse cardiovascular events in the Biomarkers in Cardiology-8 (BiC-8) study were similarly low in patients discharged from the ED using the early rule-out process and in those who received standard, guideline-recommended care, which includes 6-12 hours of serial ECGs and troponin measurements in the chest pain unit, Dr. Martin Moeckel reported at the annual congress of the European Society of Cardiology.
"This biomarker strategy using a state-of-the-art quantitative troponin assay in combination with an ultrasensitive copeptin assay has the potential to change clinical practice with high patient safety," observed Dr. Moeckel of Charité Hospital, Berlin. The copeptin test is approved for use in the European Union but remains investigational in the United States.
Based upon the results of BiC-8, this dual biomarker for early rule-out of myocardial infarction (MI) is now standard clinical practice at Charité, he added.
The rationale for developing the early rule-out strategy tested in BiC-8 lies in the serious overcrowding that is now the norm in many EDs. This overcrowding has been shown to be in and of itself a risk factor for poor outcomes. The quandary is that nearly 12% of all patients who present to the ED do so because of chest pain, yet after an extensive and time-consuming evaluation only 1 in 10 of those patients is found to actually be having an acute MI.
"Rapid rule-out of acute MI is therefore a major clinical need, saving the health care system time and resources, and saving patients unnecessary stress, anxiety, and other risks," he said.
Copeptin is a marker for vasopressin, a hemodynamic stress indicator that shoots up immediately in an acute MI. In earlier studies, a negative result for both troponin and copeptin in an initial blood sample drawn at ED presentation had a 99% negative predictive value for MI.
The BiC-8 trial included 902 low- to intermediate-risk patients who presented with suspected acute coronary syndrome (ACS) to EDs in university medical centers. All had a negative initial cardiac troponin test. They were randomized to standard care in the chest pain unit, including serial troponin testing and ECGs, or to the experimental strategy, in which physicians were informed of the copeptin results from the same initial blood sample as the troponin. If the copeptin test was positive as defined by a level of 10 pmol/L or more, the patient was hospitalized for standard care. If the copeptin result was negative, however, the patient was immediately discharged with a scheduled outpatient visit within 72 hours.
Of the patients in the copeptin group, 66% were discharged directly from the ED, compared with 12% in the standard-care group.
The 30-day incidence of major adverse cardiovascular events (MACE) was 5.5% in the standard-care group and nearly identical at 5.46% in the copeptin group. However, physicians were permitted under the study protocol to overrule negative biomarker test results on the basis of their final clinical assessment, such as if their suspicions were aroused due to recurrent symptoms or new information about the patient’s history. In this per-protocol analysis, the 30-day MACE rate was 5.68% in the standard-care group and 3.18% in the copeptin group.
MACE was defined in BiC-8 as all-cause mortality, MI, rehospitalization for ACS, acute unplanned percutaneous coronary intervention (PCI), coronary artery bypass surgery, life-threatening arrhythmia, or resuscitation from cardiac arrest.
MACE occurred in 14 copeptin-negative patients. However, 12 of the 14 were not discharged early because physicians overruled the negative biomarker results and moved the patients into standard in-hospital management. Two patients, or 0.6% of those discharged from the ED on the basis of a negative copeptin test had adverse events: One was rehospitalized on day 23 and underwent acute unplanned PCI on the next day, and the other was rehospitalized on day 4 and underwent coronary artery bypass graft surgery on day 12.
American Heart Association Immediate Past President Donna K. Arnett, Ph.D., said in an interview that she’d really like to see a second, confirmatory randomized trial before this early rule-out strategy is widely adopted. She considers the lost-to-follow-up rate uncomfortably high: 63 patients in the intention-to-treat analysis, and another 75 not accounted for in the per-protocol analysis, noted Dr. Arnett, professor and chair of the epidemiology department at the University of Alabama, Birmingham.
BiC-8 coinvestigator Dr. Kurt Huber said in an interview that the dual-biomarker early rule-out strategy is now used routinely in the hospital where he practices. Yet like Dr. Arnett, he considers a confirmatory test "extremely important" before concluding that the strategy is ready for prime-time use in every ED.
"The most important message from BiC-8, I think, is that these were patients at low to intermediate risk; they’re not the high-risk patients. And it’s also important that the physician doesn’t rely only on the test result, but also takes a final look at the clinical situation before releasing the patient. There is some overruling when patients are biomarker-negative but have typical risk markers. No test is 100% accurate. Clinical judgment remains extremely important," emphasized Dr. Huber, professor and director of cardiology and emergency medicine at Wilhelminen Hospital, Vienna.
The BiC-8 trial was sponsored by ThermoFisher Scientific and six university medical centers in German-speaking Europe. Dr. Moeckel reported receiving a research grant from ThermoFisher and serving as a consultant to Bayer, AstraZeneca, and The Medicines Company. Dr. Arnett and Dr. Huber had no conflicts of interest to declare.
AT THE ESC CONGRESS 2013
Major finding: Of the patients in the copeptin group, 66% were discharged directly from the emergency department, compared with 12% in the standard-care group.
Data source: BiC-8, a prospective, randomized multicenter trial involving 902 low- to intermediate-risk patients who presented to emergency departments with suspected acute coronary syndrome and a negative initial troponin assay.
Disclosures: The BiC-8 trial was sponsored by ThermoFisher Scientific and six university medical centers in German-speaking Europe. Dr. Moeckel reported receiving a research grant from ThermoFisher and serving as a consultant to Bayer, AstraZeneca, and The Medicines Company. Dr. Arnett and Dr. Huber had no conflicts of interest to declare.
