Prolonged dual antiplatelet therapy in stable coronary disease: comparative observational study of benefits and harms in unselected versus trial populations
Autor: | Anoop D. Shah, Eleni Rapsomaniki, Harry Hemingway, Alireza Moayyeri, Dimitris Stogiannis, Sheng-Chia Chung, Mar Pujades-Rodriguez, C Emmas, Laura Pasea, Adam Timmis, Spiros Denaxas |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
Male
medicine.medical_specialty Ticagrelor Adenosine Time Factors Population Myocardial Infarction Coronary Disease Hemorrhage 030204 cardiovascular system & hematology Cohort Studies 03 medical and health sciences 0302 clinical medicine Risk Factors Internal medicine Cause of Death medicine Secondary Prevention Electronic Health Records Humans 030212 general & internal medicine Myocardial infarction education Stroke Aged Aged 80 and over education.field_of_study Clinical Trials as Topic Aspirin business.industry Research General Medicine Middle Aged medicine.disease 3. Good health Surgery Cardiovascular Diseases Relative risk Platelet aggregation inhibitor Drug Therapy Combination Female business TIMI Platelet Aggregation Inhibitors Cohort study medicine.drug |
Zdroj: | The BMJ |
ISSN: | 1756-1833 0959-8138 |
Popis: | Objective To estimate the potential magnitude in unselected patients of the benefits and harms of prolonged dual antiplatelet therapy after acute myocardial infarction seen in selected patients with high risk characteristics in trials. Design Observational population based cohort study. Setting PEGASUS-TIMI-54 trial population and CALIBER (ClinicAl research using LInked Bespoke studies and Electronic health Records). Participants 7238 patients who survived a year or more after acute myocardial infarction. Interventions Prolonged dual antiplatelet therapy after acute myocardial infarction. Main outcome measures Recurrent acute myocardial infarction, stroke, or fatal cardiovascular disease. Fatal, severe, or intracranial bleeding. Results 1676/7238 (23.1%) patients met trial inclusion and exclusion criteria (“target” population). Compared with the placebo arm in the trial population, in the target population the median age was 12 years higher, there were more women (48.6% v 24.3%), and there was a substantially higher cumulative three year risk of both the primary (benefit) trial endpoint of recurrent acute myocardial infarction, stroke, or fatal cardiovascular disease (18.8% (95% confidence interval 16.3% to 21.8%) v 9.04%) and the primary (harm) endpoint of fatal, severe, or intracranial bleeding (3.0% (2.0% to 4.4%) v 1.26% (TIMI major bleeding)). Application of intention to treat relative risks from the trial (ticagrelor 60 mg daily arm) to CALIBER’s target population showed an estimated 101 (95% confidence interval 87 to 117) ischaemic events prevented per 10 000 treated per year and an estimated 75 (50 to 110) excess fatal, severe, or intracranial bleeds caused per 10 000 patients treated per year. Generalisation from CALIBER’s target subgroup to all 7238 real world patients who were stable at least one year after acute myocardial infarction showed similar three year risks of ischaemic events (17.2%, 16.0% to 18.5%), with an estimated 92 (86 to 99) events prevented per 10 000 patients treated per year, and similar three year risks of bleeding events (2.3%, 1.8% to 2.9%), with an estimated 58 (45 to 73) events caused per 10 000 patients treated per year. Conclusions This novel use of primary-secondary care linked electronic health records allows characterisation of “healthy trial participant” effects and confirms the potential absolute benefits and harms of dual antiplatelet therapy in representative patients a year or more after acute myocardial infarction. |
Databáze: | OpenAIRE |
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