April 12, 2011Circulation248 citationsOpen Access
View Full PaperFrequency and Predictors of Stent Thrombosis After Percutaneous Coronary Intervention in Acute Myocardial Infarction
Key Result
Bivalirudin monotherapy resulted in similar 2-year rates of stent thrombosis compared to heparin plus a glycoprotein IIb/IIIa inhibitor (4.3% vs 4.6%; P=0.73) in STEMI patients undergoing primary PCI.
Study Design
Type
RCT (n=3,602)
Randomization
randomized
Structured PICO
Does bivalirudin monotherapy compared to heparin plus a glycoprotein IIb/IIIa inhibitor affect the rate of stent thrombosis in patients with STEMI undergoing primary PCI?
P
Population
3602 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)
I
Intervention
Bivalirudin monotherapy
C
Comparator
Heparin plus a glycoprotein IIb/IIIa inhibitor (GPI)
O
Outcome
Definite or probable stent thrombosis within 2 yearshard clinical
In STEMI patients undergoing primary PCI, bivalirudin monotherapy and heparin plus a GPI result in similar overall 2-year rates of stent thrombosis, though bivalirudin is associated with higher acute but lower post-24-hour stent thrombosis risk.
Main Result
Absolute Event Rate: 4.3% vs 4.6%
p-value: p=0.73
Abstract
BACKGROUND: Concerns persist regarding the risk of stent thrombosis in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. METHODS AND RESULTS: The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial included 3602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention who were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) (n=1802) versus bivalirudin monotherapy (n=1800). Stents were implanted in 3202 patients, including 2261 who received drug-eluting stents and 861 who received only bare metal stents. Definite or probable stent thrombosis within 2 years occurred in 137 patients (4.4%), including 28 acute events (0.9%), 49 subacute events (1.6%), 32 late events (1.0%), and 33 very late events (1.1%). The 2-year cumulative rates of stent thrombosis were 4.4% with both drug-eluting stents and bare metal stents (P=0.98) and 4.3% versus 4.6% in patients randomized to bivalirudin monotherapy versus heparin plus a GPI, respectively (P=0.73). Acute stent thrombosis occurred more frequently in patients assigned to bivalirudin compared with heparin plus a GPI (1.4% versus 0.3%; P<0.001), whereas stent thrombosis after 24 hours occurred less frequently in patients with bivalirudin compared with heparin plus a GPI (2.8% versus 4.4%; P=0.02). Pre-randomization heparin and a 600-mg clopidogrel loading dose were independent predictors of reduced acute and subacute stent thrombosis, respectively. CONCLUSIONS: Stent thrombosis is not uncommon within the first 2 years after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction, and occurs with similar frequency in patients receiving drug-eluting stents versus bare metal stents and bivalirudin alone versus heparin plus a GPI. Optimizing adjunct pharmacology including early antithrombin therapy preloading with a potent antiplatelet therapy may further reduce stent thrombosis in ST-segment elevation myocardial infarction.
Cite This Study
Dangas et al. (Tue,) conducted a rct in ST-segment elevation myocardial infarction (n=3,602). Bivalirudin monotherapy vs. Heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) was evaluated on Definite or probable stent thrombosis within 2 years (p=0.73). Bivalirudin monotherapy resulted in similar 2-year rates of stent thrombosis compared to heparin plus a glycoprotein IIb/IIIa inhibitor (4.3% vs 4.6%; P=0.73) in STEMI patients undergoing primary PCI.