Abstract 986: Hematomas of at Least 5 Cm and Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention: Insights From The STEEPLE Trial
Background: In patients undergoing percutaneous coronary intervention (PCI), bleeding has a significant impact on outcomes including 1-year mortality. There is no uniform definition of bleeding and hematomas ≥ 5 cm at the femoral puncture are considered major bleeding events in some trials. In the STEEPLE trial groin hematomas ≥ 5 cm (excluding retroperitoneal bleeds) were classified as minor bleeds. This subanalysis of the STEEPLE trial assessed the impact of hematomas on patient outcomes and 1-year mortality.
Methods: In STEEPLE, 3528 patients undergoing elective PCI received intravenous enoxaparin (enox; 0.5 or 0.75 mg/kg) or unfractionated heparin (UFH). Bleeding sites and size of haematomas were collected. The 30-day outcomes and 1-year mortality of patients with a hematoma ≥ 5 cm were compared to outcomes in patients with no major or minor bleeding.
Results: Data on hematomas were available for 3342 patients. Of these, 103 patients (29, 33, 41 in enox 0.5, 0.75 and UFH groups, respectively) had a hematoma ≥ 5 cm; none required transfusion. The 30-day mortality rate, non-fatal myocardial infarction (MI), or urgent target-vessel revascularization (UTVR) were similar between patients with a hematoma ≥ 5 cm and those with no bleeding. All-cause mortality was similar in both groups (Table⇓).
Conclusion: The presence of hematomas ≥ 5 cm had no effect on the 30-day ischemic outcomes and 1-year mortality in patients undergoing elective PCI in the STEEPLE trial. Beyond patient discomfort, hematomas ≥ 5 cm were not associated with need for transfusions, and had no effect on prognosis in this analysis. It remains to be determined how to use them in bleeding classifications.