Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial.
OBJECTIVE
To determine the relationship between anticoagulation levels during percutaneous coronary intervention, and ischaemic events and bleeding.


RESULTS
A sub-analysis from the STEEPLE trial was conducted. Pre-defined target anticoagulation levels were achieved in 86% of patients receiving enoxaparin, compared with 20% receiving unfractionated heparin (UFH) (P < 0.001). A significant relationship was observed between anti-Xa levels > 0.9 IU/mL and covariate-adjusted rate of non-coronary artery bypass graft-related major and minor bleeding [odds ratio (OR) 1.6, 95% CI 1.0-2.5 for each unit of anti-Xa; P = 0.03]; anti-Xa levels and covariate-adjusted incidence of death, myocardial infarction, or revascularization showed no significance (P = 0.47). Major bleeding increased significantly with an activated clotting time (ACT) > 325 s (OR 1.6, 95% CI 1.1-2.2 per 100 s; P = 0.04). A significant relationship with increasing ischaemic events was observed when ACT was < 325 s (OR 0.7, 95% CI 0.2-0.8 per 100 s; P = 0.006) indicating a narrow therapeutic window.


CONCLUSIONS
Target anticoagulation levels were achieved more readily in patients receiving enoxaparin. An anti-Xa level of up to 0.9 IU/mL has a good safety and efficacy profile; poor achievement of target ACT with UFH makes assessing the optimal range difficult.
Montalescot
Gilles
G
Institut de Cardiologie (AP-HP) and INSERM Unit no. 856, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France. gilles.montalescot@psl.aphp.fr
Cohen
Marc
M
Salette
Genevieve
G
Desmet
Walter J
WJ
Macaya
Carlos
C
Aylward
Philip E G
PE
Steg
Ph Gabriel
PG
White
Harvey D
HD
Gallo
Richard
R
Steinhubl
Steven R
SR
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000925:Anticoagulants / Q000008:administration & dosage* / Q000097:blood; D003328:Coronary Thrombosis / Q000097:blood / Q000517:prevention & control; D017984:Enoxaparin / Q000008:administration & dosage / Q000097:blood; D065427:Factor Xa Inhibitors; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000097:blood; D006493:Heparin / Q000008:administration & dosage* / Q000097:blood; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000097:blood / Q000517:prevention & control; D017202:Myocardial Ischemia / Q000097:blood / Q000628:therapy*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000008:administration & dosage; D014914:Whole Blood Coagulation Time / Q000379:methods
D000925:Anticoagulants; D017984:Enoxaparin; D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin