Abstract 2463: The Relationship Between Obesity, Diabetes and Outcomes in Elective Percutaneous Coronary Intervention: Results from the STEEPLE Trial
Background: Obesity and diabetes are potential risk factors for bleeding or ischemic events in percutaneous coronary intervention (PCI). We compared bleeding and ischemic outcomes following PCI in patients who were obese (BMI ≥ 30 kg/m2) or diabetic with those who were not.
Methods: STEEPLE was a prospective, open-label, randomized trial in 3528 patients undergoing elective PCI. Patients received a bolus of intravenous enoxaparin (enox; 0.5 or 0.75 mg/kg), or an activated clotting time-adjusted unfractionated heparin (UFH) regimen, stratified by use of a glycoprotein IIb/IIIa inhibitor. Enox 0.5 mg/kg was associated with a significant 31% reduction in bleeding compared with UFH (P=0.01); a 24% reduction was associated with enox 0.75 mg/kg (P=0.052). Efficacy was similar among treatment groups. Bleeding was defined as non-coronary artery bypass graft (CABG)-related major and minor bleeding up to 48 hours; efficacy as a composite of all-cause mortality, nonfatal myocardial infarction and urgent target vessel revascularization up to 30 days.
Results: In STEEPLE, 1227 (35.1%) patients were obese and 1062 (30.1%) were diabetic. Bleeding rates were similar for obese (7.1%) and non-obese patients (7.3%; P=0.84), and for diabetics (7.0%) and non-diabetics (7.2%; P=0.83). There was a trend toward reduced bleeding in all patient groups treated with enox compared with UFH; a significant reduction was observed for obese patients with enox 0.5 mg/kg (Table⇓). The efficacy endpoint was comparable between obese (6.3%) and non-obese patients (6.4%; P=0.90), and between diabetics (6.0%) and non-diabetics (6.5%; P=0.56), independent of the anticoagulation regimen.
Conclusion: In this analysis of patients undergoing elective PCI in the STEEPLE trial, obesity and diabetes did not affect bleeding or ischemic events. Bleeding was reduced in obese patients treated with enox 0.5 mg/kg compared with UFH.