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TEMPORAL TRENDS IN USE OF COMPOSITE ENDPOINTS IN MAJOR CARDIOVASCULAR RANDOMIZED CLINICAL TRIALS
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Canadian Journal of Cardiology Volume 33 2017
with a GRACE score < 119 (Figure). Of the 1290 low-risk patients, 579 (45%) required critical care restricted intravenous therapies; but, this was almost exclusively intravenous nitroglycerin (578 patients). Only one patient required dopamine. A total of 10 (0.8%) required non-invasive mechanical ventilation; none required invasive mechanical ventilation. CONCLUSION: In a large cohort of patients with low-risk GRACE scores admitted to a CCU, no in-hospital mortality was observed. In addition, there was no need for need for advanced critical care therapies beyond intravenous nitroglycerin. These findings support the routine admission of lowrisk ACS patients to low-intensity hospital telemetry wards when critical care restricted therapies are not required. Future initiatives designed to decrease unnecessary low-risk CCU admissions have the potential to reduce critical care capacity strain and hospital costs.
Canadian Cardiovascular Society (CCS) Moderated Presentations PUBLIC POLICY AND POPULATION BASED RESEARCH POTPOURRI PART 2 Sunday, October 22, 2017 171 TEMPORAL TRENDS IN USE OF COMPOSITE ENDPOINTS IN MAJOR CARDIOVASCULAR RANDOMIZED CLINICAL TRIALS N Tan, S Ali, G Lebovic, M Mamdani, A Laupacis, A Yan Toronto, Ontario BACKGROUND:
Cardiovascular mortality has decreased significantly over the last three decades, with a corresponding increase in the difficulty of demonstrating significant benefits of new therapies in randomized clinical trials. We sought to
determine whether the use of composite endpoints has increased in major cardiovascular trials over time, and to examine temporal trends in the clinical importance of their individual components. METHODS: Using a previously validated search strategy, we searched MEDLINE for cardiovascular publications appearing in the New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association between 1986 and 2015. Articles that met all of the following criteria were included: a) randomized trial of a pharmacologic or nonpharmacologic intervention, b) the intervention was a treatment for primary or secondary cardiovascular prevention, c) the primary outcome was a clinical event. We abstracted and categorized study population demographics, type of intervention, and primary and secondary outcomes. Composite endpoint components were ranked by importance (minor, moderate, major, critical, and death), and temporal trends analyzed. RESULTS: Our search strategy retrieved 2607 unique trials, of which 604 trials met inclusion criteria. Use of composite endpoints increased significantly over time from 19% between 1986-1990 to 83% between 2011-2015 (P < 0.001). The number of components in the primary endpoint also increased significantly (median 1 in 1986-1990, median 3 in 20112015, P < 0.001). There was no association between the number of components in the composite endpoint and statistically significant trial results (P¼0.25). Contemporary trials were more likely to include endpoints of lesser importance to patients (minor 3.1% and moderate 6.3% in 1986-1990, minor 4.5% and moderate 44.6% in 2011-2015; P < 0.001). The use of death as the sole primary endpoint declined significantly over time (53.1% in 1986-1990, 17.9% in 20112015, P < 0.001). CONCLUSION: Contemporary cardiovascular trials are more likely to use primary composite endpoints, which contain a larger number of components. These components are increasingly of lesser clinical importance.
Canadian Journal of Cardiology Volume 33 2017
with a GRACE score < 119 (Figure). Of the 1290 low-risk patients, 579 (45%) required critical care restricted intravenous therapies; but, this was almost exclusively intravenous nitroglycerin (578 patients). Only one patient required dopamine. A total of 10 (0.8%) required non-invasive mechanical ventilation; none required invasive mechanical ventilation. CONCLUSION: In a large cohort of patients with low-risk GRACE scores admitted to a CCU, no in-hospital mortality was observed. In addition, there was no need for need for advanced critical care therapies beyond intravenous nitroglycerin. These findings support the routine admission of lowrisk ACS patients to low-intensity hospital telemetry wards when critical care restricted therapies are not required. Future initiatives designed to decrease unnecessary low-risk CCU admissions have the potential to reduce critical care capacity strain and hospital costs.
Canadian Cardiovascular Society (CCS) Moderated Presentations PUBLIC POLICY AND POPULATION BASED RESEARCH POTPOURRI PART 2 Sunday, October 22, 2017 171 TEMPORAL TRENDS IN USE OF COMPOSITE ENDPOINTS IN MAJOR CARDIOVASCULAR RANDOMIZED CLINICAL TRIALS N Tan, S Ali, G Lebovic, M Mamdani, A Laupacis, A Yan Toronto, Ontario BACKGROUND:
Cardiovascular mortality has decreased significantly over the last three decades, with a corresponding increase in the difficulty of demonstrating significant benefits of new therapies in randomized clinical trials. We sought to
determine whether the use of composite endpoints has increased in major cardiovascular trials over time, and to examine temporal trends in the clinical importance of their individual components. METHODS: Using a previously validated search strategy, we searched MEDLINE for cardiovascular publications appearing in the New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association between 1986 and 2015. Articles that met all of the following criteria were included: a) randomized trial of a pharmacologic or nonpharmacologic intervention, b) the intervention was a treatment for primary or secondary cardiovascular prevention, c) the primary outcome was a clinical event. We abstracted and categorized study population demographics, type of intervention, and primary and secondary outcomes. Composite endpoint components were ranked by importance (minor, moderate, major, critical, and death), and temporal trends analyzed. RESULTS: Our search strategy retrieved 2607 unique trials, of which 604 trials met inclusion criteria. Use of composite endpoints increased significantly over time from 19% between 1986-1990 to 83% between 2011-2015 (P < 0.001). The number of components in the primary endpoint also increased significantly (median 1 in 1986-1990, median 3 in 20112015, P < 0.001). There was no association between the number of components in the composite endpoint and statistically significant trial results (P¼0.25). Contemporary trials were more likely to include endpoints of lesser importance to patients (minor 3.1% and moderate 6.3% in 1986-1990, minor 4.5% and moderate 44.6% in 2011-2015; P < 0.001). The use of death as the sole primary endpoint declined significantly over time (53.1% in 1986-1990, 17.9% in 20112015, P < 0.001). CONCLUSION: Contemporary cardiovascular trials are more likely to use primary composite endpoints, which contain a larger number of components. These components are increasingly of lesser clinical importance.