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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
- Source :
- Lancet (UK), 389(10073), 1025-1034. Elsevier Ltd.
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- Background Dual antiplatelet therapy (DAPT) with aspirin plus a P2Y12 inhibitor prevents ischaemic events after coronary stenting, but increases bleeding. Guidelines support weighting bleeding risk before the selection of treatment duration, but no standardised tool exists for this purpose. Methods A total of 14â963 patients treated with DAPT after coronary stentingâlargely consisting of aspirin and clopidogrel and without indication to oral anticoagulationâwere pooled at a single-patient level from eight multicentre randomised clinical trials with independent adjudication of events. Using Cox proportional hazards regression, we identified predictors of out-of-hospital Thrombosis in Myocardial Infarction (TIMI) 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 PLATelet inhibition and patient Outcomes (PLATO) trial (n=8595) and BernPCI registry (n=6172). The novel score was assessed within patients randomised to different DAPT durations (n=10â081) to identify the effect on bleeding and ischaemia of a long (12â24 months) or short (3â6 months) treatment in relation to baseline bleeding risk. Findings The PRECISE-DAPT score (age, creatinine clearance, haemoglobin, 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% CI 0·61â0·85) in the derivation cohort, and 0·70 (0·65â0·74) in the PLATO trial validation cohort and 0·66 (0·61â0·71) in the BernPCI registry validation cohort. A longer DAPT duration significantly increased bleeding in patients at high risk (score â¥25), but not in those with lower risk profiles (pinteraction=0·007), and exerted a significant ischaemic benefit only in this latter group. Interpretation The PRECISE-DAPT score is a simple five-item risk score, which provides a standardised tool for the prediction of out-of-hospital bleeding during DAPT. In the context of a comprehensive clinical evaluation process, this tool can support clinical decision making for treatment duration. Funding None.
- Subjects :
- medicine.medical_specialty
Ticlopidine
medicine.medical_treatment
Myocardial Infarction
Hemorrhage
Context (language use)
Coronary Artery Disease
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
Lower risk
Risk Assessment
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Internal medicine
medicine
Humans
Multicenter Studies as Topic
030212 general & internal medicine
Aged
Randomized Controlled Trials as Topic
Aged, 80 and over
Aspirin
Framingham Risk Score
business.industry
Medicine (all)
Percutaneous coronary intervention
General Medicine
Middle Aged
Clopidogrel
Surgery
Clinical trial
Treatment Outcome
Purinergic P2Y Receptor Antagonists
Drug Therapy, Combination
Stents
business
Platelet Aggregation Inhibitors
TIMI
medicine.drug
Subjects
Details
- ISSN :
- 01406736
- Volume :
- 389
- Database :
- OpenAIRE
- Journal :
- The Lancet
- Accession number :
- edsair.doi.dedup.....fe9ce92ade34d206a564807e46a51244