Elizabeth A Magnuson1, Haiyan Li2, Kaijun Wang2, Katherine Vilain2, Ali Shafiq2, Marc P Bonaca3, Deepak L Bhatt3, Marc Cohen4, Philippe Gabriel Steg5, Robert F Storey6, Eugene Braunwald3, Marc S Sabatine3, David J Cohen7. 1. Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri Kansas City, Kansas City, Missouri. Electronic address: emagnuson@saint-lukes.org. 2. Saint Luke's Mid America Heart Institute, Kansas City, Missouri. 3. Thrombosis In Myocardial Infarction (TIMI) Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. 4. Cardiovascular Division, Department of Medicine, Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School, Newark, New Jersey. 5. French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire Fibrosis, Inflammation, Remodeling, Hôpital Bichat, Assistance Publique-Hôpitaux de Pars, INSERM Unité 1148, Paris, France; Université Paris-Diderot, Sorbonne Paris Cité, Paris, France. 6. Department of Cardiovascular Science, University of Sheffield, Sheffield, United Kingdom. 7. Saint Luke's Mid America Heart Institute, Kansas City, Missouri; University of Missouri Kansas City, Kansas City, Missouri.
Abstract
BACKGROUND: In patients with a myocardial infarction (MI) 1 to 3 years earlier, treatment withticagrelor + low-dose aspirin (ASA) reduces the risk of cardiovascular (CV) death, MI, or stroke compared with low-dose aspirin alone, but at an increased risk of major bleeding. OBJECTIVES: The authors evaluated cost-effectiveness of ticagrelor + low-dose ASA in patients with prior MI within the prior 3 years. METHODS: The authors performed a prospective economic substudy alongside the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack UsingTicagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction 54) trial, which randomized 21,162 patients to ASA alone, ticagrelor 60 mg twice daily + low-dose ASA, or ticagrelor 90 mg twice daily + low-dose ASA. Medical resource use data were collected over a median 33-month follow-up. Costs were assessed from the U.S. health care system perspective. In-trial data relating to survival, utility, and costs were combined with lifetime projections to evaluate lifetime cost-effectiveness of the Food and Drug Administration-approved lower-dose ticagrelor regimen (60 mg twice daily). RESULTS:Hospitalization costs were similar for ticagrelor 60 mg and placebo ($2,262 vs. $2,333; 95% confidence interval for difference -$303 to $163; p = 0.54); after inclusion of a daily ticagrelor 60 mg cost of $10.52, total costs were higher for ticagrelor ($10,016 vs. $2,333; 95% CI: $7,441 to $7,930; p < 0.001). In-trial quality-adjusted life-years (QALYs) were similar (2.28 vs. 2.27; p = 0.34). Over a lifetime horizon, ticagrelor was associated with QALY gains of 0.078 and incremental costs of $7,435, yielding an incremental cost-effectiveness ratio (ICER) of $94,917/QALY gained. Several high-risk groups had more favorable ICERs, including patients with >1 prior MI, multivessel disease, diabetes, renal dysfunction (all with ICERs $50,000 to $70,000/QALY gained), patients age <75 years (ICER = $44,779/QALY gained), and patients with peripheral artery disease (ICER = $13,427/QALY gained). CONCLUSIONS: For patients with a history of MI >1 year previously, long-term treatment with ticagrelor 60 mg + low-dose ASA yields a cost-effectiveness ratio suggesting intermediate value based on current guidelines. Ticagrelor appears to provide higher value for patients in several recognized high-risk subgroups. (Prevention of Cardiovascular Events [e.g., Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack UsingTicagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562).
RCT Entities:
BACKGROUND: In patients with a myocardial infarction (MI) 1 to 3 years earlier, treatment with ticagrelor + low-dose aspirin (ASA) reduces the risk of cardiovascular (CV) death, MI, or stroke compared with low-dose aspirin alone, but at an increased risk of major bleeding. OBJECTIVES: The authors evaluated cost-effectiveness of ticagrelor + low-dose ASA in patients with prior MI within the prior 3 years. METHODS: The authors performed a prospective economic substudy alongside the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis In Myocardial Infarction 54) trial, which randomized 21,162 patientsto ASA alone, ticagrelor 60 mg twice daily + low-dose ASA, or ticagrelor 90 mg twice daily + low-dose ASA. Medical resource use data were collected over a median 33-month follow-up. Costs were assessed from the U.S. health care system perspective. In-trial data relating to survival, utility, and costs were combined with lifetime projections to evaluate lifetime cost-effectiveness of the Food and Drug Administration-approved lower-dose ticagrelor regimen (60 mg twice daily). RESULTS: Hospitalization costs were similar for ticagrelor 60 mg and placebo ($2,262 vs. $2,333; 95% confidence interval for difference -$303 to $163; p = 0.54); after inclusion of a daily ticagrelor 60 mg cost of $10.52, total costs were higher for ticagrelor ($10,016 vs. $2,333; 95% CI: $7,441 to $7,930; p < 0.001). In-trial quality-adjusted life-years (QALYs) were similar (2.28 vs. 2.27; p = 0.34). Over a lifetime horizon, ticagrelor was associated with QALY gains of 0.078 and incremental costs of $7,435, yielding an incremental cost-effectiveness ratio (ICER) of $94,917/QALY gained. Several high-risk groups had more favorable ICERs, including patients with >1 prior MI, multivessel disease, diabetes, renal dysfunction (all with ICERs $50,000 to $70,000/QALY gained), patients age <75 years (ICER = $44,779/QALY gained), and patients with peripheral artery disease (ICER = $13,427/QALY gained). CONCLUSIONS: For patients with a history of MI >1 year previously, long-term treatment with ticagrelor 60 mg + low-dose ASA yields a cost-effectiveness ratio suggesting intermediate value based on current guidelines. Ticagrelor appears to provide higher value for patients in several recognized high-risk subgroups. (Prevention of Cardiovascular Events [e.g., Death From Heart or Vascular Disease, Heart Attack, or Stroke] in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin [PEGASUS]; NCT01225562).
Authors: Patrizia Natale; Suetonia C Palmer; Valeria M Saglimbene; Marinella Ruospo; Mona Razavian; Jonathan C Craig; Meg J Jardine; Angela C Webster; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2022-02-28
Authors: Stuart Pocock; David B Brieger; Ruth Owen; Jiyan Chen; Mauricio G Cohen; Shaun Goodman; Christopher B Granger; José C Nicolau; Tabassome Simon; Dirk Westermann; Satoshi Yasuda; Katarina Hedman; Carl Mellström; Karolina Andersson Sundell; Richard Grieve Journal: Open Heart Date: 2021-02
Authors: David J Cohen; Kaijun Wang; Elizabeth Magnuson; Robert Smith; Mark C Petrie; Mamta Heena Buch; William Abraham; Joann Lindenfeld; Michael J Mack; Gregg W Stone; John G F Cleland Journal: Heart Date: 2022-01-25 Impact factor: 7.365
Authors: Michelle Samuel; Jean-Claude Tardif; Paul Khairy; François Roubille; David D Waters; Jean C Grégoire; Fausto J Pinto; Aldo P Maggioni; Rafael Diaz; Colin Berry; Wolfgang Koenig; Petr Ostadal; Jose Lopez-Sendon; Habib Gamra; Ghassan S Kiwan; Marie-Pierre Dubé; Mylène Provencher; Andreas Orfanos; Lucie Blondeau; Simon Kouz; Philippe L L'Allier; Reda Ibrahim; Nadia Bouabdallaoui; Dominic Mitchell; Marie-Claude Guertin; Jacques Lelorier Journal: Eur Heart J Qual Care Clin Outcomes Date: 2021-09-16