TY - JOUR
T1 - 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
AU - White, Harvey
AU - Aylward, Philip
AU - Gallo, Richard
AU - Bode, Christoph
AU - Steg, Gabriel
AU - Steinhubl, Steven
AU - Montalescot, Gilles
PY - 2010/1
Y1 - 2010/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=72149101267&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2009.10.034
DO - 10.1016/j.ahj.2009.10.034
M3 - Article
SN - 0002-8703
VL - 159
SP - 110
EP - 116
JO - American Heart Journal
JF - American Heart Journal
IS - 1
ER -