Evaluation of clinical risk factors to predict high on-treatment platelet reactivity and outcome in patients with stable coronary artery disease (PREDICT-STABLE)

PLoS One. 2015 Mar 23;10(3):e0121620. doi: 10.1371/journal.pone.0121620. eCollection 2015.

Abstract

Objectives: This study was designed to identify the multivariate effect of clinical risk factors on high on-treatment platelet reactivity (HPR) and 12 months major adverse events (MACE) under treatment with aspirin and clopidogrel in patients undergoing non-urgent percutaneous coronary intervention (PCI).

Methods: 739 consecutive patients with stable coronary artery disease (CAD) undergoing PCI were recruited. On-treatment platelet aggregation was tested by light transmittance aggregometry. Clinical risk factors and MACE during one-year follow-up were recorded. An independent population of 591 patients served as validation cohort.

Results: Degree of on-treatment platelet aggregation was influenced by different clinical risk factors. In multivariate regression analysis older age, diabetes mellitus, elevated BMI, renal function and left ventricular ejection fraction were independent predictors of HPR. After weighing these variables according to their estimates in multivariate regression model, we developed a score to predict HPR in stable CAD patients undergoing elective PCI (PREDICT-STABLE Score, ranging 0-9). Patients with a high score were significantly more likely to develop MACE within one year of follow-up, 3.4% (score 0-3), 6.3% (score 4-6) and 10.3% (score 7-9); odds ratio 3.23, P=0.02 for score 7-9 vs. 0-3. This association was confirmed in the validation cohort.

Conclusions: Variability of on-treatment platelet function and associated outcome is mainly influenced by clinical risk variables. Identification of high risk patients (e.g. with high PREDICT-STABLE score) might help to identify risk groups that benefit from more intensified antiplatelet regimen. Additional clinical risk factor assessment rather than isolated platelet function-guided approaches should be investigated in future to evaluate personalized antiplatelet therapy in stable CAD-patients.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Aged
  • Body Mass Index
  • Coronary Artery Disease / blood
  • Coronary Artery Disease / surgery*
  • Diabetes Complications
  • Female
  • Humans
  • Kidney Function Tests
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Odds Ratio
  • Percutaneous Coronary Intervention / adverse effects*
  • Platelet Aggregation / drug effects
  • Platelet Aggregation Inhibitors / therapeutic use
  • Platelet Function Tests
  • Postoperative Complications / epidemiology*
  • ROC Curve
  • Regression Analysis
  • Risk Factors
  • Stents / adverse effects
  • Thrombosis / epidemiology*
  • Thrombosis / prevention & control
  • Treatment Outcome

Substances

  • Platelet Aggregation Inhibitors

Grants and funding

This work was supported by the Deutsche Forschungsgemeinschaft, (www.dfg.de) (Grant SCHW 858/1-1 and Klinische Forschergruppe 274 Platelets – Molecular Mechanisms and Translational Implications), the FP7 EU Initial Training Network program Fighting-DrugFailure, (http://www.fightingdrugfailure.net) (Grant PITN-GA-2009-238132), and the Robert Bosch Stiftung, (www.bosch-stiftung.de), Germany. We acknowledge support by Deutsche Forschungsgemeinschaft and Open Access Publishing Fund of Tuebingen University. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.