Martin Putera1, Robin Roark2, Renato D Lopes3, Krishna Udayakumar4, Eric D Peterson5, Robert M Califf6, Bimal R Shah7. 1. Duke-National University of Singapore Graduate Medical School, Singapore. 2. Duke University School of Medicine, Durham, NC. 3. Duke Clinical Research Institute, Durham, NC. 4. Duke-National University of Singapore Graduate Medical School, Singapore; Duke University School of Medicine, Durham, NC. 5. Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC. 6. Duke University School of Medicine, Durham, NC; Duke Translational Medicine Institute, Durham, NC. 7. Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: bimal.shah@duke.edu.
Abstract
BACKGROUND: The use of evidence-based therapies has improved the outcome of patients with acute coronary syndrome (ACS), but there is a time lag between the generation of clinical evidence and its application in routine clinical practice. We sought to quantify temporal lags in the lifecycle of American College of Cardiology (ACC)/American Heart Association (AHA) class IA ACS therapies. METHODS: Using current and historical ACC/AHA guideline publications, we retrieved publication dates of pivotal clinical trials (PCTs) and class IA guideline-recommended therapies for patients with ST-elevation myocardial infarction (STEMI) and unstable angina (UA)/non-STEMI (NSTEMI). Clinical practice uptake data for each therapy were retrieved from the National Registry for Myocardial Infarction, Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines, and Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines, which are registries containing publicly available peer-reviewed data. Descriptive data were calculated and compared for each phase of the evidence lifecycle for both STEMI and UA/NSTEMI drug classifications. RESULTS: We identified 11 class IA- and 4 class IB/IC-recommended therapies for acute, inhospital, and discharge use for patients with STEMI or UA/NSTEMI. The median time lags were 2 years (interquartile range [IQR], 1-4 years) from PCT to practice guideline recommendation, 14 years (IQR, 11-15 years) from guideline recommendation to 90% practice uptake, and overall, a 16-year median (IQR, 13-19 years) from PCT to 90% practice uptake. CONCLUSIONS: The time of PCT publication to meaningful uptake of class IA ACS therapies into clinical practice took a median of 16 years. This significant time lag indicates systemic barriers to the translation of therapeutics into routine clinical practice.
BACKGROUND: The use of evidence-based therapies has improved the outcome of patients with acute coronary syndrome (ACS), but there is a time lag between the generation of clinical evidence and its application in routine clinical practice. We sought to quantify temporal lags in the lifecycle of American College of Cardiology (ACC)/American Heart Association (AHA) class IA ACS therapies. METHODS: Using current and historical ACC/AHA guideline publications, we retrieved publication dates of pivotal clinical trials (PCTs) and class IA guideline-recommended therapies for patients with ST-elevation myocardial infarction (STEMI) and unstable angina (UA)/non-STEMI (NSTEMI). Clinical practice uptake data for each therapy were retrieved from the National Registry for Myocardial Infarction, Can Rapid Risk Stratification of Unstable AnginaPatients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines, and Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines, which are registries containing publicly available peer-reviewed data. Descriptive data were calculated and compared for each phase of the evidence lifecycle for both STEMI and UA/NSTEMI drug classifications. RESULTS: We identified 11 class IA- and 4 class IB/IC-recommended therapies for acute, inhospital, and discharge use for patients with STEMI or UA/NSTEMI. The median time lags were 2 years (interquartile range [IQR], 1-4 years) from PCT to practice guideline recommendation, 14 years (IQR, 11-15 years) from guideline recommendation to 90% practice uptake, and overall, a 16-year median (IQR, 13-19 years) from PCT to 90% practice uptake. CONCLUSIONS: The time of PCT publication to meaningful uptake of class IA ACS therapies into clinical practice took a median of 16 years. This significant time lag indicates systemic barriers to the translation of therapeutics into routine clinical practice.
Authors: Lieven Annemans; Nicolas Danchin; Frans Van de Werf; Stuart Pocock; Muriel Licour; Jesús Medina; Héctor Bueno Journal: Open Heart Date: 2016-02-24
Authors: Jean-Pierre Bassand; Gabriele Accetta; Wael Al Mahmeed; Ramon Corbalan; John Eikelboom; David A Fitzmaurice; Keith A A Fox; Haiyan Gao; Samuel Z Goldhaber; Shinya Goto; Sylvia Haas; Gloria Kayani; Karen Pieper; Alexander G G Turpie; Martin van Eickels; Freek W A Verheugt; Ajay K Kakkar Journal: PLoS One Date: 2018-01-25 Impact factor: 3.240