Abstract 3073: Development and Validation of a Bleeding Risk Model for Major Bleeding in Patients Undergoing Elective Percutaneous Coronary Intervention: the STEEPLE Trial
Background: Major bleeding is a serious issue in PCI, but no bleeding score exists for evaluating patients before the procedure. We developed a bleeding risk model for non-coronary artery bypass graft (CABG)-related major bleeding based on the findings from the STEEPLE trial.
Methods: STEEPLE was a prospective, open-label, randomized trial in 3528 patients undergoing elective PCI. Patients received a bolus of intravenous enoxaparin (0.5 or 0.75 mg/kg) or an activated clotting time-adjusted unfractionated heparin (UFH) regimen, stratified by glycoprotein (GP) IIb/IIIa inhibitor use. Enoxaparin was associated with a significant 57% reduction in non-CABG-related major bleeding (P<0.01) and similar efficacy compared with UFH. One set of patients (2/3) was randomly selected to develop the model and the remaining patients (1/3) were used to validate the model. Logistic regression and bootstrap methods were used to create a risk score for major bleeding.
Results: In the derivation set, the model identified 3 predictors for major bleeding: female gender, use of UFH (vs. enoxaparin) and use of GP IIb/IIIa inhibitor (vs. no use). Area under the ROC curve was 0.75 (95%CI [0.70; 0.82]). Risk scores ranged from 0–5: female gender was assigned 5, use of UFH 3, and use of GP IIb/IIIa inhibitor 2 (Table⇓). Patients were classified as low risk (score of 0–5) or high risk (score >5). Among patients in the validation set, 1.91% had major bleeding; the model predicted 1.84%; area under the ROC curve was 0.70. Similarly, 1.24% of low-risk and 5.29% of high-risk patients had major bleeding; the model predicted 1.04% and 5.95%, respectively. The model fit the data well in both sets (Hosmer-Lemeshow test: P=0.29 and P=0.59, respectively).
Conclusion: We propose a model for evaluating bleeding risk in patients undergoing elective PCI. Our model identified 3 predictors to score the risk and accurately predicted the incidence of major bleeding in patients undergoing elective PCI in the STEEPLE trial.