April 16, 2014Circulation Cardiovascular Interventions15 citationsOpen Access
Heparin Monotherapy or Bivalirudin During Percutaneous Coronary Intervention in Patients With Non–ST-Segment–Elevation Acute Coronary Syndromes or Stable Ischemic Heart Disease
View Full Paper
Key Result
Bivalirudin use during PCI was associated with lower bleeding compared to unfractionated heparin in NSTE-ACS (difference -3.3%; P=0.01) and SIHD (difference -1.8%; P=0.01) without increasing ischemia.
Study Design
Type
Observational (n=3,098)
Structured PICO
Does bivalirudin monotherapy reduce bleeding and ischemic outcomes compared to unfractionated heparin monotherapy in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention?
P
Population
3,098 patients (1,036 with non-ST-segment-elevation acute coronary syndromes and 2,062 with stable ischemic heart disease) from the EVENT registry undergoing percutaneous coronary intervention.
I
Intervention
Bivalirudin monotherapy during percutaneous coronary intervention
C
Comparator
Unfractionated heparin monotherapy during percutaneous coronary intervention
O
Outcome
Primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary ischemic outcomes (in-hospital death/myocardial infarction)composite
Bivalirudin monotherapy during PCI in patients with NSTE-ACS or SIHD is associated with reduced in-hospital bleeding compared to unfractionated heparin monotherapy, without increasing ischemic outcomes.
Main Result
Effect estimate: Difference -3.3% (NSTE-ACS) and -1.8% (SIHD) for bleeding (95% CI -0.8% to -5.8% (NSTE-ACS); -0.4% to -3.3% (SIHD))
p-value: p=0.01
Abstract
BACKGROUND: The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. METHODS AND RESULTS: The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% -0.8% to -5.8%; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% 4.1% to -1.8%; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% 1.3% to -1.3%; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% -0.4% to -3.3%; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% 2.3% to -1.5%; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% 0.7% to -0.7%; P=1.00) when compared with unfractionated heparin monotherapy. CONCLUSIONS: Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use during percutaneous coronary intervention when compared with unfractionated heparin monotherapy was associated with lower bleeding without significant increase in ischemic outcomes or stent thrombosis.