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.
- Costa F Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland; Erasmus University Medical Center, Rotterdam, Netherlands; Department of Clinical and Experimental Medicine, Policlinic "G Martino", University of Messina, Messina, Italy.
- van Klaveren D Erasmus University Medical Center, Rotterdam, Netherlands; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
- James S Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
- Heg D Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
- Räber L Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
- Feres F Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.
- Pilgrim T Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
- Hong MK Severance Cardiovascular Hospital, Yonsei University College of Medicine and Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
- Kim HS Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
- Colombo A EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
- Steg PG Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Bichat Hospital, Paris, France.
- Zanchin T Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
- Palmerini T Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Bologna, Italy.
- Wallentin L Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
- Bhatt DL Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.
- Stone GW Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.
- Windecker S Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
- Steyerberg EW Erasmus University Medical Center, Rotterdam, Netherlands.
- Valgimigli M Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland; Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: marco.valgimigli@insel.ch.
- 2017-03-15
Published in:
- Lancet (London, England). - 2017
Aged
Aged, 80 and over
Aspirin
Clopidogrel
Coronary Artery Disease
Drug Therapy, Combination
Hemorrhage
Humans
Kaplan-Meier Estimate
Middle Aged
Multicenter Studies as Topic
Myocardial Infarction
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Randomized Controlled Trials as Topic
Risk Assessment
Stents
Ticlopidine
Treatment Outcome
English
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 14 963 patients treated with DAPT after coronary stenting-largely consisting of aspirin and clopidogrel and without indication to oral anticoagulation-were 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=10 081) to identify the effect on bleeding and ischaemia of a long (12-24 months) or short (3-6 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 0·61-0·85) 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 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.
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 14 963 patients treated with DAPT after coronary stenting-largely consisting of aspirin and clopidogrel and without indication to oral anticoagulation-were 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=10 081) to identify the effect on bleeding and ischaemia of a long (12-24 months) or short (3-6 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 0·61-0·85) 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 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.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1016/S0140-6736(17)30397-5
- PMID 28290994
- Persistent URL
- https://folia.unifr.ch/global/documents/177910
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