Abstract
AimsThe aim of this study is to develop models to aid the decision to prolong dual antiplatelet therapy (DAPT) that requires balancing an individual patient’s potential benefits and harms.Methods and resultsUsing population-based electronic health records (EHRs) (CALIBER, England, 2000–10), of patients evaluated 1 year after acute myocardial infarction (MI), we developed (n = 12 694 patients) and validated (n = 5613) prognostic models for cardiovascular (cardiovascular death, MI or stroke) events and three different bleeding endpoints. We applied trial effect estimates to determine potential benefits and harms of DAPT and the net clinical benefit of individuals. Prognostic models for cardiovascular events (c-index: 0.75 (95% CI: 0.74, 0.77)) and bleeding (c index 0.72 (95% CI: 0.67, 0.77)) were well calibrated: 3-year risk of cardiovascular events was 16.5% overall (5.2% in the lowest- and 46.7% in the highest-risk individuals), while for major bleeding, it was 1.7% (0.3% in the lowest- and 5.4% in the highest-risk patients). For every 10 000 patients treated per year, we estimated 249 (95% CI: 228, 269) cardiovascular events prevented and 134 (95% CI: 87, 181) major bleeding events caused in the highest-risk patients, and 28 (95% CI: 19, 37) cardiovascular events prevented and 9 (95% CI: 0, 20) major bleeding events caused in the lowest-risk patients. There was a net clinical benefit of prolonged DAPT in 63–99% patients depending on how benefits and harms were weighted.ConclusionPrognostic models for cardiovascular events and bleeding using population-based EHRs may help to personalise decisions for prolonged DAPT 1-year following acute MI.
Highlights
Among patients who survived a year since their last acute myocardial infarction (MI), subsequent major cardiovascular events, all-cause mortality and major bleeding risks are high.[1,2]
The PEGASUS-TIMI 54 trial[4] found prolonged dual antiplatelet therapy (DAPT) using aspirin and ticagrelor compared with aspirin alone in patients 1–3 years since their last acute MI reduced the risk of cardiovascular death, stroke, or MI by 16% but increased major bleeding two-fold
The cardiovascular and bleeding event rates from one-year post-MI in the development and validation cohorts are shown in Supplementary material online, Figure S2
Summary
Among patients who survived a year since their last acute myocardial infarction (MI), subsequent major cardiovascular events, all-cause mortality and major bleeding risks are high.[1,2] In unselected populations in USA, Sweden, England, and France, 20% of such patients experienced subsequent MI, stroke, or died during the following 3 years.[2]. The PEGASUS-TIMI 54 trial[4] found prolonged dual antiplatelet therapy (DAPT) using aspirin and ticagrelor compared with aspirin alone in patients 1–3 years since their last acute MI reduced the risk of cardiovascular death, stroke, or MI by 16% but increased major bleeding two-fold. In light of this evidence, 2015 European Society of Cardiology guidelines recommend prolonged DAPT may be ‘considered after careful assessment of ischaemic and bleeding risks’.5,6
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