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Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial.

Publication ,  Journal Article
Ward, R; Huang, Z; Rockhold, FW; Baumgartner, I; Berger, JS; Blomster, JI; Fowkes, FGR; Katona, BG; Mahaffey, KW; Norgren, L; Vemulapalli, S ...
Published in: Am Heart J
February 2020

BACKGROUND: Rates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events. METHODS: EUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. RESULTS: TIMI major bleeding occurred in 2.3% of participants overall (0.94 event/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and β-blocker use. Patients with TIMI major bleeding postrandomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40-5.84; P < .0001) compared with those without major bleeding; the association was strongest within 30 days after a bleeding event. CONCLUSIONS: In patients with symptomatic PAD, 0.94 major bleeding event/100 patient-years was observed and associated with older age, residing in North America, disease severity, and β-blocker use. Patients who had a major bleeding event were significantly more likely to experience MACE, especially within the first 30 days, when compared with patients who did not have major bleeding.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2020

Volume

220

Start / End Page

51 / 58

Location

United States

Related Subject Headings

  • Time Factors
  • Ticagrelor
  • Risk Factors
  • Residence Characteristics
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Middle Aged
  • Male
  • Intention to Treat Analysis
  • Incidence
 

Citation

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Ward, R., Huang, Z., Rockhold, F. W., Baumgartner, I., Berger, J. S., Blomster, J. I., … Jones, W. S. (2020). Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J, 220, 51–58. https://doi.org/10.1016/j.ahj.2019.11.007
Ward, Rachael, Zhen Huang, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F Gerry R. Fowkes, et al. “Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial.Am Heart J 220 (February 2020): 51–58. https://doi.org/10.1016/j.ahj.2019.11.007.
Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, et al. Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J. 2020 Feb;220:51–8.
Ward, Rachael, et al. “Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial.Am Heart J, vol. 220, Feb. 2020, pp. 51–58. Pubmed, doi:10.1016/j.ahj.2019.11.007.
Ward R, Huang Z, Rockhold FW, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Katona BG, Mahaffey KW, Norgren L, Vemulapalli S, Povsic TJ, Mehta R, Hiatt WR, Patel MR, Jones WS. Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. Am Heart J. 2020 Feb;220:51–58.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2020

Volume

220

Start / End Page

51 / 58

Location

United States

Related Subject Headings

  • Time Factors
  • Ticagrelor
  • Risk Factors
  • Residence Characteristics
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Middle Aged
  • Male
  • Intention to Treat Analysis
  • Incidence