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Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial

for, t. S. et al.

American heart journal. VOL 159; NUMBER 1, ; 2010, 110-116 -- Elsevier Science B.V., Amsterdam (pages 110-116) -- 2010

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  • Title:
    Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial
  • Author: for, t. S.;
    White, H. D.;
    Aylward, P. E.;
    Gallo, R.;
    Bode, C.;
    Steg, G.;
    Steinhubl, S. R.;
    Montalescot, G.
  • Found In: American heart journal. VOL 159; NUMBER 1, ; 2010, 110-116
  • Journal Title: American heart journal.
  • Subjects: Medicine; Biotechnology; Pharmaceutical Chemistry; LCC: RC681; Dewey: 616.12
  • Publication Details: Elsevier Science B.V., Amsterdam
  • Language: English
  • Abstract: Background: Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas >=5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others. Limited information is available on the incidence and clinical relevance of hematomas >=5 cm in PCI patients. Methods: Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas >=5 cm on ischemic outcomes (mortality, nonfatal myocardial infarction, or urgent target vessel revascularization) up to day 30 and all-cause 1-year mortality. Hematoma data were available for 3,342 of 3,528 patients in STEEPLE. Patients with (n = 103) and without (n = 3,239) hematomas >=5 cm were evenly distributed across treatment groups. Results: No differences were observed in 30-day ischemic outcomes between patients with and without hematomas (5.8% vs 5.9%, respectively; P = .96). No transfusions were observed in patients with hematomas as compared with patients without hematomas (0% and 0.4%, respectively; P = .52). A greater reduction in hemoglobin was observed (pre- vs post-PCI) in patients with hematomas as compared with patients without hematomas (-0.84 vs -0.35 g/L, P .001). No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas (0.0% vs 1.7%, P = .98). Conclusions: After PCI, hematomas >=5 cm had no effect on 30-day ischemic events or 1-year mortality. Although there is no agreed classification for large hematomas, the lack of a relationship between hematomas >=5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE.
  • Identifier: Journal ISSN: 0002-8703
  • Publication Date: 2010
  • Physical Description: Electronic
  • Accrual Information: Monthly
  • Shelfmark(s): 0817.000000
  • UIN: ETOCRN263045517

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