Bivalirudin Superior to Heparin in 'Real World' Patients with ACS Undergoing PCI + Coronary Stenting

SAN FRANCISCO, CA—Use of bivalirudin alone was superior to heparin alone with respect to all-cause mortality in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) plus coronary stenting, results of a study presented at ACC.13, the American College of Cardiology's 62nd Annual Scientific Session has found.

These findings suggest that “bivalirudin monotherapy is advantageous over other anticoagulant strategies in a ‘real world' setting when the higher bleeding complication rate in the combined antithrombotic strategy heparin + glycoprotein IIb/IIIa inhibitors (GPIs) is taken into account,” noted Miklos Rohla, MD, and colleagues from the 3rd Department of Medicine, Cardiology and Emergency Medicine, Wilhelminenspital, and the Department of Cardiology, Medical University, Vienna, Austria.

Although “the role of bivalirudin monotherapy in patients undergoing PCI has been studied extensively in randomized controlled trials,” the investigators noted that real world clinical data—including in patients ineligible for trials due to age, risk profile, impaired renal function, or low levels of hemoglobin—“are scarce.”

They evaluated 1,201 consecutive patients admitted between January 2003 and February 2011 with a diagnosis of ACS who were referred for PCI plus stent implantation. All patients received aspirin and clopidogrel or prasugrel (beginning in 2010) as basal dual antiplatelet therapy.

Clinical outcome, defined as all-cause mortality, was compared among patients receiving peri-interventional anticoagulation with bivalirudin alone, heparin alone, or heparin plus GPIs, respectively, they reported. Mean follow-up was 58 ± 27 months.

A total of 127 patients (10.6%) received bivalirudin alone; 665 (55.4%), heparin alone; and 408 (34.0%), heparin plus GPIs. Of selected baseline variables, age, gender, glomerular filtration rate, hemoglobin, current smoking, peripheral artery disease, prior stroke or TIA, and atrial fibrillation were all significantly different among the three groups. Not significant were BMI, systolic blood pressure at admission, family history of coronary artery disease, hypertension, hyperlipidemia, diabetes, or heart failure.

In the Cox proportional-hazards model, peri-interventional anticoagulation with bivalirudin, compared with heparin plus GPIs, resulted in similar rates of all-cause death (HR 0.61 [0.33–1.14]; P=0.12). However, anticoagulation with bivalirudin alone vs. heparin alone resulted in significantly lower rates of all-cause mortality (HR 0.50 [0.27–0.90], P=0.02), as did bivalirudin vs. a pooled heparin strategy (HR 0.53 [0.30-0.96]; P=0.04).

This study provides evidence that bivalirudin may be administered as monotherapy in patients with ACS referred for PCI plus stenting, the investigators concluded.