Original article
Usefulness of the PARIS Score to Evaluate the Ischemic-hemorrhagic Net Benefit With Ticagrelor and Prasugrel After an Acute Coronary SyndromeUtilidad de la puntuación PARIS para evaluar el equilibrio isquémico-hemorrágico con ticagrelor y prasugrel tras un síndrome coronario agudo

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Abstract

Introduction and objectives

The PARIS score allows combined stratification of ischemic and hemorrhagic risk in patients with ischemic heart disease treated with coronary stenting and dual antiplatelet therapy (DAPT). Its usefulness in patients with acute coronary syndrome (ACS) treated with ticagrelor or prasugrel is unknown. We investigated this issue in an international registry.

Methods

Retrospective multicenter study with voluntary participation of 11 centers in 6 European countries. We studied 4310 patients with ACS discharged with DAPT with ticagrelor or prasugrel. Ischemic events were defined as stent thrombosis or spontaneous myocardial infarction, and hemorrhagic events as BARC (Bleeding Academic Research Consortium) type 3 or 5 bleeding. Discrimination and calibration were calculated for both PARIS scores (PARISischemic and PARIShemorrhagic). The ischemic-hemorrhagic net benefit was obtained by the difference between the predicted probabilities of ischemic and bleeding events.

Results

During a period of 17.2 ± 8.3 months, there were 80 ischemic events (1.9% per year) and 66 bleeding events (1.6% per year). PARISischemic and PARIShemorrhagic scores were associated with a risk of ischemic events (sHR, 1.27; 95%CI, 1.16-1.39) and bleeding events (sHR, 1.14; 95%CI, 1.01-1.30), respectively. The discrimination for ischemic events was modest (C index = 0.64) and was suboptimal for hemorrhagic events (C index = 0.56), whereas calibration was acceptable for both. The ischemic-hemorrhagic net benefit was negative (more hemorrhagic events) in patients at high hemorrhagic risk, and was positive (more ischemic events) in patients at high ischemic risk.

Conclusions

In patients with ACS treated with DAPT with ticagrelor or prasugrel, the PARIS model helps to properly evaluate the ischemic-hemorrhagic risk.

Resumen

Introducción y objetivos

La puntuación PARIS permite una estratificación combinada de los riesgos isquémico y hemorrágico de los pacientes con cardiopatía isquémica tratados con stent coronario y tratamiento antiagregante plaquetario doble (TAPD). Se desconoce su utilidad en pacientes con síndrome coronario agudo (SCA) tratados con ticagrelor o prasugrel. Se investiga este aspecto en un registro internacional.

Métodos

Estudio retrospectivo multicéntrico con participación voluntaria de 11 centros de 6 países europeos. Se estudió a 4.310 pacientes con SCA dados de alta en TAPD con ticagrelor o prasugrel. Se definió evento isquémico como trombosis de stent o infarto de miocardio espontáneo, y evento hemorrágico según BARC (Bleeding Academic Research Consortium) tipo 3 o 5. Se calculó la discriminación y la calibración para ambas vertientes de la puntuación PARIS (PARISisquémico y PARIShemorrágico). El beneficio neto isquémico-hemorrágico se obtuvo mediante la diferencia entre las probabilidades predichas de eventos isquémicos y hemorrágicos.

Resultados

Durante 17,2 ± 8,3 meses, hubo 80 eventos isquémicos (el 1,9% anual) y 66 eventos hemorrágicos (el 1,6% anual). PARISisquémico y PARIShemorrágico se asociaron con el riesgo de eventos isquémicos (sHR = 1,27; IC95%, 1,16-1,39) y hemorrágicos (sHR = 1,14; IC95%, 1,01-1,30) respectivamente. La discriminación de eventos isquémicos fue discreta (índice C = 0,64) y la de eventos hemorrágicos, pobre (índice C = 0,56), con buena calibración para ambos. El beneficio neto isquémico-hemorrágico resultó negativo (más eventos hemorrágicos) en pacientes con alto riesgo hemorrágico y positivo (más eventos isquémicos) en pacientes con alto riesgo isquémico.

Conclusiones

En pacientes con SCA tratados con TAPD con ticagrelor o prasugrel, la escala PARIS ayuda a establecer un equilibrio apropiado del riesgo isquémico-hemorrágico.

Section snippets

INTRODUCTION

Dual antiplatelet therapy (DAPT) is one of the cornerstones used in the treatment of acute coronary syndrome (ACS).1 Combining DAPT with aspirin and a P2Y12 inhibitor has helped reduce the recurrence of ischemic events after ACS.2, 3, 4 However, use of this combination increases the bleeding risk, thus also worsening the prognosis.5 Achieving balanced antithrombotic therapy that maximizes the benefits of use (lowering ischemic risk without raising bleeding risk) is one of the objectives of

Study Population

The RENAMI (REgistry of New Antiplatelet therapy in patients with acute Myocardial Infarction) registry is a retrospective, observational, multicenter, international registry with voluntary participation of 11 sites in 6 European countries (Spain, Italy, Switzerland, Greece, Serbia, and the United Kingdom). This registry is an unfunded, investigator-dependent registry that arose from the need to learn more about the clinical benefit (ischemic-hemorrhagic risk) of DAPT with ticagrelor vs

Study Population and Events

The mean age of the 4310 patients studied was 60.9 ± 11.5, and 20.8% were women. In all, 58.0% had ST-segment elevation AMI; 32.9% had AMI without ST-segment elevation, and 9.0% had unstable angina; 11.1% were in Killip class ≥ II.

A total of 61.4% (n = 2647) were treated with DAPT with ticagrelor. Six-month GRACE score data were available for 1528 (35.4%) patients, with a value of 120.7 ± 32.1 points. The mean GRACE score was 118.3 ± 32.1 points in patients with non–ST-segment elevation ACS and

DISCUSSION

This study demonstrates the usefulness of the PARIS scale to optimize ischemic-hemorrhagic net benefit in a population of ACS patients treated by percutaneous coronary intervention who received DAPT with ticagrelor or prasugrel. The information in this international registry, which has more than 4000 real-life patients, validates the 2 risk scores (ischemic and hemorrhagic) of the PARIS scale. The discriminatory capacity of ischemic events was modest, whereas that of hemorrhagic episodes was

CONCLUSIONS

In ACS patients treated by percutaneous coronary intervention during hospitalization and DAPT with ticagrelor or prasugrel at discharge, the PARIS scale could be useful to estimate ischemic-hemorrhagic net benefit, thus helping to determine the best antithrombotic strategy for each patient in terms of DAPT type and duration.

CONFLICTS OF INTEREST

E. Abu-Assi is associate editor of Revista Española de Cardiología.

WHAT IS KNOWN ABOUT THE TOPIC?

  • –

    The PARIS score has been developed in a population of patients with ischemic heart disease (< 50% ACS) treated by percutaneous revascularization with a drug-eluting stent and dual antiplatelet therapy (> 90% with clopidogrel). In addition to demonstrating adequate predictive capacity for both ischemic and bleeding events, its advantage largely lies in its capacity to combine both risks in a single patient, making it easier to

References (27)

  • S.D. Wiviott et al.

    TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes

    N Engl J Med.

    (2007)
  • L. Wallentin et al.

    Ticagrelor versus clopidogrel in patients with acute coronary syndromes

    N Engl J Med.

    (2009)
  • M. Valgimigli et al.

    Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial

    Eur Heart J.

    (2017)

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    © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.