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Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without
Guillaume Marquis-Gravel1, Megan L Neely1, Marco Valgimigli2
1Duke Clinical Research Institute, Durham, NC (G.M.G., M.L.N., R.A., E.M.O., M.T.R.).
Insights
Bleeding risk scores like PRECISE-DAPT, PARIS, and DAPT show reasonable performance in predicting bleeding events in acute coronary syndrome (ACS) patients treated with dual antiplatelet therapy (DAPT) without revascularization. These scores can aid shared decision-making for managing bleeding risk.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Longitudinal bleeding risk scores are validated for patients undergoing percutaneous coronary intervention (PCI) with dual antiplatelet therapy (DAPT).
- The applicability of these scores to acute coronary syndrome (ACS) patients managed medically without revascularization is uncertain.
- This study evaluates bleeding risk scores in ACS patients treated with DAPT but not undergoing revascularization.
Purpose of the Study:
- To evaluate and compare the performance of PRECISE-DAPT, PARIS, and DAPT bleeding risk scores.
- To assess the predictive accuracy of these scores for bleeding events in medically managed ACS patients on DAPT.
Main Methods:
- Analysis of the TRILOGY ACS randomized trial data (N=9326).
- Application of PRECISE-DAPT, PARIS, and DAPT bleeding risk scores to predict non-coronary artery bypass grafting (CABG)-related GUSTO severe/life-threatening/moderate and TIMI major/minor bleeding.
- Time-dependent c-indices were calculated to assess predictive performance over 12 months.
Main Results:
- The c-indices for predicting GUSTO bleeding at 12 months were 0.716 (PRECISE-DAPT), 0.693 (PARIS), and 0.674 (DAPT).
- The c-indices for predicting TIMI bleeding at 12 months were 0.624 (PRECISE-DAPT), 0.612 (PARIS), and 0.608 (DAPT).
- No significant differences were observed in the predictive performance between the scores for either bleeding endpoint.
Conclusions:
- PRECISE-DAPT, PARIS, and DAPT bleeding risk scores demonstrated reasonable and comparable performance in medically managed ACS patients on DAPT.
- These scores' performance was similar to that observed in PCI populations.
- Bleeding risk scores can assist in predicting longitudinal bleeding risk and support shared decision-making in this patient group.
Background:
Longitudinal bleeding risk scores have been validated in patients treated with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention. How these scores apply to the population of patients with acute coronary syndrome (ACS) treated without revascularization remains unknown. The objective was to evaluate and compare the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) bleeding risk scores in the medically managed patients with ACS treated with DAPT.
Methods And Results:
TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a double-blind, placebo-controlled randomized trial conducted from 2008 to 2012 over a median follow-up of 17.0 months in 966 sites (52 countries). High-risk patients with unstable angina or non-ST-segment-elevation myocardial infarction who did not undergo revascularization were randomized to prasugrel or clopidogrel. The PRECISE-DAPT, PARIS, and DAPT (bleeding component) risk scores were applied in the TRILOGY ACS population to evaluate their performance to predict adjudicated non-coronary artery bypass grafting-related GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe/life-threatening/moderate and TIMI (Thrombolysis in Myocardial Infarction) major/minor bleeding with time-dependent c-indices. Among the 9326 participants, median age was 66 years (interquartile range, 59-74 years), and 3650 were females (39.1%). A total of 158 (1.69%) GUSTO severe/life-threatening/moderate and 174 (1.87%) TIMI major/minor non-coronary artery bypass grafting bleeding events occurred. The c-indices (95% CI) of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores through 12 months were 0.716 (0.677-0.758), 0.693 (0.658-0.733), and 0.674 (0.637-0.713), respectively, for GUSTO bleeding and 0.624 (0.582-0.666), 0.612 (0.578-0.651), and 0.608 (0.571-0.649), respectively, for TIMI bleeding. There was no significant difference in the c-indices of each score based upon pairwise comparisons.
Conclusions:
Among medically managed patients with ACS treated with DAPT, the performances of the PRECISE-DAPT, PARIS, and DAPT (bleeding component) scores were reasonable and similar to their performances in the derivation percutaneous coronary intervention populations. Bleeding risk scores may be used to predict longitudinal bleeding risk in patients with ACS treated with DAPT without revascularization and help support shared decision making. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00699998.
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