Validation of PRECISE-DAPT Bleeding Risk Score

Mar 30, 2017
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Authors:
Costa F, van Klaveren D, James S, et al., on behalf of the PRECISE-DAPT Study Investigators.
Citation:
Derivation and Validation of the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) Score: A Pooled Analysis of Individual-Patient Datasets From Clinical Trials. Lancet 2017;389:1025-1034.
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What is the validity of a novel risk score for the prediction of out-of-hospital bleeding in patients treated with dual antiplatelet therapy (DAPT)?

Methods:

The investigators pooled 14,963 patients treated with DAPT after coronary stenting, largely consisting of aspirin and clopidogrel and without indication to oral anticoagulation at a single-patient level from eight multicenter randomized clinical trials with independent adjudication of events. Using Cox proportional hazards regression, they identified predictors of out-of-hospital TIMI (Thrombosis in Myocardial Infarction) major or minor bleeding stratified by trial, and developed a numerical bleeding risk score. The predictive performance of the novel score was assessed in the derivation cohort and validated in patients treated with percutaneous coronary intervention from the PLATO (PLATelet inhibition and patient Outcomes) trial (n = 8,595) and BernPCI registry (n = 6,172). The novel score was assessed within patients randomized to different DAPT durations (n = 10,081) to identify the effect on bleeding and ischemia of a long (12–24 months) or short (3–6 months) treatment in relation to baseline bleeding risk.

Results:

The PRECISE-DAPT score (age, creatinine clearance, hemoglobin, white-blood-cell count, and previous spontaneous bleeding) showed a c-index for out-of-hospital TIMI major or minor bleeding of 0.73 (95% confidence interval, 0.61–0.85) in the derivation cohort, and 0.70 (0.65–0.74) in the PLATO trial validation cohort and 0.66 (0.61–0.71) in the BernPCI registry validation cohort. A longer DAPT duration significantly increased bleeding in patients at high risk (score ≥25), but not in those with lower risk profiles (pinteraction = 0.007), and exerted a significant ischemic benefit only in this latter group.

Conclusions:

The authors concluded that the PRECISE-DAPT score, a simple five-item risk score, provides a standardized tool for the prediction of out-of-hospital bleeding during DAPT.

Perspective:

This pooled analysis reports the PRECISE-DAPT score, a simple five-item prediction algorithm for the prediction of out-of-hospital bleeding in patients treated with DAPT. This score identified patients in whom the benefits of prolonged DAPT outweighed the risks and vice versa. While this tool can support clinical decision making for treatment duration, the risk for both bleeding and ischemia is dynamic, and periodic re-evaluation is needed in patients on longer-term DAPT. It should also be kept in mind that risk scores, like PRECISE-DAPT, are not a substitute for individualized critical judgment. Furthermore, this score needs prospective validation in clinical practice.

Keywords: Acute Coronary Syndrome, Algorithms, Aspirin, Blood Platelets, Creatinine, Hemoglobins, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Primary Prevention, Risk Factors, Stents, Thrombosis, Ticlopidine


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