Justin A Ezekowitz1, Robert C Welsh2, Courtney Gubbels3, Neil Brass4, Michael Chan4, William Keeble5, Fadi Khadour6, Thomas L Koshy7, Darren Knapp8, Sanjay Sharma9, Sunil Sookram10, Wayne Tymchak2, Dale Weiss8, Cynthia M Westerhout3, Paul W Armstrong3. 1. Canadian VIGOUR Centre at the University of Alberta, Edmonton, Alberta, Canada; Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada. Electronic address: jae2@ualberta.ca. 2. Canadian VIGOUR Centre at the University of Alberta, Edmonton, Alberta, Canada; Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada. 3. Canadian VIGOUR Centre at the University of Alberta, Edmonton, Alberta, Canada. 4. Royal Alexandra Hospital, Edmonton, Alberta, Canada. 5. Misericordia Hospital, Edmonton, Alberta, Canada. 6. Sturgeon Community Hospital and Health Centre, Edmonton, Alberta, Canada. 7. Alere, Inc, Edmonton, Alberta, Canada. 8. Alberta Health Services, Edmonton, Alberta, Canada. 9. Grey Nuns Community Hospital, Edmonton, Alberta, Canada. 10. University of Alberta Hospital, Edmonton, Alberta, Canada.
Abstract
BACKGROUND: The outcomes of acute cardiovascular symptom presentations are potentially modifiable with the use of biomarkers to accelerate accurate diagnosis. This randomized trial tested troponin and B-type natriuretic peptide before hospital guidance in patients with acute cardiovascular symptoms. METHODS:Patients with either chest pain or shortness of breath were randomized to usual care or biomarkers analyzed using a point-of-care device in the ambulance. The primary end point was time to final disposition (discharge from the emergency department or admission to hospital). The trial was stopped prematurely because of less than expected enrollment of patients of interest and no difference in the primary end point. RESULTS: We randomized 491 patients; 480 formed the final cohort. Patients were 49% male; median age 70 years; 42% had previous acute coronary syndrome; and 28% diabetes. The B-type natriuretic peptide level before hospital arrival was ≥ 100 pg/mL in 36.4%. Troponin was > 0.03 ng/mL in 13.4%; 3.6% had troponin > 0.1 ng/mL. After adjudication, 16% had acute coronary syndrome, 6.5% acute heart failure, 3.3% angina, and 74.2% another diagnosis. The primary end point was 9.2 (interquartile range, 7.3-11.1) hours in the biomarker group and 8.8 (interquartile range, 6.3-12.1) hours in the usual care group (P = 0.6). None died in the ambulance or in the emergency department: all-cause 30-day mortality was 2.1% (usual care) and 1.7% (biomarker). CONCLUSIONS: To our knowledge, this is the first randomized trial of biomarkers before hospital arrival to guide emergency management of suspected acute cardiovascular disease which showed no benefit and was terminated early because of futility. The results have important implications for the use of biomarkers in emergency management of heart disease and for the design of future randomized trials on this important topic.
RCT Entities:
BACKGROUND: The outcomes of acute cardiovascular symptom presentations are potentially modifiable with the use of biomarkers to accelerate accurate diagnosis. This randomized trial tested troponin and B-type natriuretic peptide before hospital guidance in patients with acute cardiovascular symptoms. METHODS:Patients with either chest pain or shortness of breath were randomized to usual care or biomarkers analyzed using a point-of-care device in the ambulance. The primary end point was time to final disposition (discharge from the emergency department or admission to hospital). The trial was stopped prematurely because of less than expected enrollment of patients of interest and no difference in the primary end point. RESULTS: We randomized 491 patients; 480 formed the final cohort. Patients were 49% male; median age 70 years; 42% had previous acute coronary syndrome; and 28% diabetes. The B-type natriuretic peptide level before hospital arrival was ≥ 100 pg/mL in 36.4%. Troponin was > 0.03 ng/mL in 13.4%; 3.6% had troponin > 0.1 ng/mL. After adjudication, 16% had acute coronary syndrome, 6.5% acute heart failure, 3.3% angina, and 74.2% another diagnosis. The primary end point was 9.2 (interquartile range, 7.3-11.1) hours in the biomarker group and 8.8 (interquartile range, 6.3-12.1) hours in the usual care group (P = 0.6). None died in the ambulance or in the emergency department: all-cause 30-day mortality was 2.1% (usual care) and 1.7% (biomarker). CONCLUSIONS: To our knowledge, this is the first randomized trial of biomarkers before hospital arrival to guide emergency management of suspected acute cardiovascular disease which showed no benefit and was terminated early because of futility. The results have important implications for the use of biomarkers in emergency management of heart disease and for the design of future randomized trials on this important topic.
Authors: Justin A Ezekowitz; Robert C Welsh; Dale Weiss; Michael Chan; William Keeble; Fadi Khadour; Sanjay Sharma; Wayne Tymchak; Sunil Sookram; Neil Brass; Darren Knapp; Thomas L Koshy; Yinggan Zheng; Paul W Armstrong Journal: J Am Heart Assoc Date: 2015-12-01 Impact factor: 5.501
Authors: Clare Goyder; Pui San Tan; Jan Verbakel; Thanusha Ananthakumar; Joseph J Lee; Gail Hayward; Philip J Turner; Ann Van Den Bruel Journal: BMJ Open Date: 2020-02-27 Impact factor: 2.692