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

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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

Costa, Francesco (författare): Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland.;Erasmus Univ, Med Ctr, Rotterdam, Netherlands.;Univ Messina, Policlin G Martino, Dept Clin & Expt Med, Messina, Italy.

van Klaveren, David (författare): Erasmus Univ, Med Ctr, Rotterdam, Netherlands.;Tufts Med Ctr, Inst Clin Res & Hlth Policy Studies, Boston, MA USA.

James, Stefan K (författare): Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)

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Heg, Dik (författare): Univ Bern, Inst Social & Prevent Med, Bern, Switzerland.

Raber, Lorenz (författare): Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland.

Feres, Fausto (författare): Ist Dante Pazzanese Cardiol, Sao Paulo, Brazil.

Pilgrim, Thomas (författare): Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland.

Hong, Myeong-Ki (författare): Yonsei Univ, Coll Med, Severance Cardiovasc Hosp, Seoul, South Korea.;Yonsei Univ, Coll Med, Severance Biomed Sci Inst, Seoul, South Korea.

Kim, Hyo-Soo (författare): Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea.

Colombo, Antonio (författare): EMO GVM Ctr Cuore Columbus, Milan, Italy.;Ist Sci San Raffaele, Intervent Cardiol Dept, Milan, Italy.

Steg, Philippe Gabriel (författare): Hop Xavier Bichat, AP HP, Dept Cardiol, Paris, France.

Zanchin, Thomas (författare): Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland.

Palmerini, Tullio (författare): Univ Bologna, Dipartimento Cardiotoracovasc, Bologna, Italy.

Wallentin, Lars (författare): Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)

Bhatt, Deepak L. (författare): Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA.;Harvard Med Sch, Boston, MA USA.

Stone, Gregg W. (författare): Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA.;Cardiovasc Res Fdn, New York, NY USA.

Windecker, Stephan (författare): Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland.

Steyerberg, Ewout W. (författare): Erasmus Univ, Med Ctr, Rotterdam, Netherlands.

Valgimigli, Marco (författare): Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland.;Erasmus Univ, Med Ctr, Rotterdam, Netherlands.

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Univ Hosp Bern, Swiss Cardiovasc Ctr Bern, CH-3010 Bern, Switzerland;Erasmus Univ, Med Ctr, Rotterdam, Netherlands.;Univ Messina, Policlin G Martino, Dept Clin & Expt Med, Messina, Italy. Erasmus Univ, Med Ctr, Rotterdam, Netherlands.;Tufts Med Ctr, Inst Clin Res & Hlth Policy Studies, Boston, MA USA. (creator_code:org_t)

2017
2017
Engelska.
Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 389:10073, s. 1025-1034

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Background: Dual antiplatelet therapy (DAPT) with aspirin plus a P2Y(12) 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 (p(interaction)=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.

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