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.
abstract: BACKGROUND
  Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas > or =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 > or =5 cm in PCI patients.
  
  
  METHODS
  Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas > or =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 > or =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 < or = .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 > or =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 > or =5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE.
authors.affiliation: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. harveyw@adhb.govt.nz
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Philip E
authors.initials: PE
authors.lastname: Aylward
authors.forename: Richard
authors.initials: R
authors.lastname: Gallo
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: Gabriel
authors.initials: G
authors.lastname: Steg
authors.forename: Steven R
authors.initials: SR
authors.lastname: Steinhubl
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D000925:Anticoagulants / Q000008:administration & dosage; D064420:Drug-Related Side Effects and Adverse Reactions; D017558:Elective Surgical Procedures; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000209:etiology / Q000473:pathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D018579:Patient Selection; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin