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P6411Dyspnea in ticagrelor treated patients in the all-comer randomized GLOBAL LEADERS study and its association with clinical outcomes
Journal article

P6411Dyspnea in ticagrelor treated patients in the all-comer randomized GLOBAL LEADERS study and its association with clinical outcomes

  • Tomaniak, M Erasmus Medical Centre, Rotterdam, Medical University of Warsaw, Warsaw, Poland
  • Chichareon, P Academic Medical Center of Amsterdam, Amsterdam, Netherlands (The)
  • Modolo, R Academic Medical Center of Amsterdam, Amsterdam, Netherlands (The)
  • Plante, S Southlake Regional Health Centre, Newmarket, Canada
  • Brunel, P Clinique de Fontaine, Paris, France
  • Beygui, F CHU de Caen, Caen, France
  • Van Geuns, R.-J Erasmus Medical Centre, Rotterdam, Radboud UMC, Nijmegen, Netherlands (The)
  • Storey, R University of Sheffield, Sheffield, United Kingdom
  • Hamm, C University of Giessen, Giessen, Germany
  • Steg, P G FACT (French Alliance for Cardiovascular Trials), Université Paris Diderot, Hôpital Bichat, Paris, France
  • Vranckx, P Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium
  • Windecker, S Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
  • Onuma, Y Erasmus Medical Centre, ThoraxCenter, Rotterdam, Netherlands (The)
  • Valgimigli, M Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
  • Serruys, P W NHLI, Imperial College London, London, United Kingdom
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  • 2019-10-21
Published in:
  • European Heart Journal. - Oxford University Press (OUP). - 2019, vol. 40, no. Supplement_1
Cardiology and Cardiovascular Medicine
English Abstract

Background
Dyspnea represents a drug adverse effect reported with a higher frequency for ticagrelor, as compared with other P2Y12 antagonists. The impact of dyspnea on clinical outcomes has not been yet evaluated in the context of aspirin-free therapies after percutaneous coronary intervention (PCI).


Purpose
The study aimed to evaluate the incidence of dyspnea and its associations with demographic characteristics and clinical outcomes in patients undergoing PCI treated with ticagrelor either as monotherapy or as a part of a dual antiplatelet therapy (DAPT) in the GLOBAL LEADERS cohort.


Methods
This is a sub-analysis of the randomized all-comer GLOBAL LEADERS study (n=15991), comparing the experimental strategy of ticagrelor monotherapy following one-month DAPT after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. The incidence of dyspnea reported as adverse event (AE) and its relation to demographic characteristics and 2-year clinical outcomes was evaluated (intention-to-treat analysis). Multivariable Cox proportional hazards models were performed, including randomized treatment and incidence of first dyspnea event as a time-dependent covariate. The primary endpoint was a composite of 2-year all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction (MI). Patient-oriented clinical endpoints (POCE) comprised all-cause death, any stroke, MI or revascularization, whereas net adverse clinical events (NACE) included POCE and Bleeding Academic Research Consortium (BARC)-defined bleeding type 3 or 5.


Results
Overall, dyspnea was reported as an AE in 2101 patients (13.2%) up to two years of follow-up, with a higher frequency in the experimental arm (16.4%) as compared with the reference group (11.1%) (hazard ratio [HR]1.70, 95% confidence interval [CI] 1.56–1.86, p=0.001).
Predictors of dyspnea AE up to 2 years by multivariate analyses were: chronic obstructive pulmonary disease (HR1.71, 95% CI 1.56–1.87, p=0.001), female gender (HR1.31, 95% CI 1.18–1.44, p=0.001), hypertension (HR1.31, 95% CI 1.19–1.44, p=0.001, prior coronary artery bypass grafting (HR1.30, 95% CI 1.10–1.54, p=0.003), left ventricle ejection fraction below 40% (HR1.22, 95% CI 1.04–1.42, p=0.012), presentation with acute coronary syndrome (HR1.19, 95% CI 1.09–1.29, p=0.001) and body mass index (≥27kg/m2) (HR1.17, 95% CI 1.08–1.28, p=0.001).
In patients who reported dyspnea AE, the two-year rates of the efficacy and safety endpoints in the experimental and reference arm were: for the primary endpoint 3.4% vs. 4.3% (p adjusted=0.807), for POCE 15.8% vs. 17.6% (p adjusted=0.218), for NACE 17.2% vs. 19.6% (p adjusted=0.082), for BARC 3 or 5 type bleeding 17.2% vs. 19.6% (p adjusted=0.082), respectively.


Conclusions
The occurrence of dyspnea AE up to two years after PCI appeared not to affect the safety of the experimental treatment strategy of 23-month ticagrelor monotherapy following one-month DAPT after PCI.


Acknowledgement/Funding
Study founded by European Cardiovascular Research Institute, which received unrestricted grants from Biosensors Int., AstraZeneca, Medicines Company.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/61267
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