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Primary PCI with bivalirudin improved clinical outcomes at 30 days
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In a pooled analysis of the HORIZONS-AMI and EUROMAX trials, primary PCI with bivalirudin was associated with improved net 30-day clinical outcomes and transfusions, but a higher rate of acute stent thrombosis, compared with unfractionated heparin plus a glycoprotein IIb/IIa inhibitor.
HORIZONS-AMI included 3,602 patients who underwent PCI for STEMI. Rates of bleeding and mortality were lower, but rates of acute stent thrombosis were higher with bivalirudin (Angiomax, The Medicines Company) vs. heparin plus a glycoprotein IIb/IIa inhibitor (GPI). EUROMAX included 2,218 patients assigned bivalirudin or heparin ± GPI, and incorporated changes in primary PCI such as the use of P2Y12 inhibitors, increased radial access and pretreatment before hospital admission, which also suggested a benefit of bivalirudin over heparin plus GPI.
Given evolutions in PCI, the aim of the pooled patient-level analysis of HORIZONS-AMI and EUROMAX was to evaluate outcomes associated with procedural anticoagulation with bivalirudin vs. heparin ± GPI. The analysis included 2,889 patients assigned bivalirudin with provisional GPI use and 2,911 assigned heparin with routine or bailout GPI use. The median age of the patients was 60 years, 23.5% were women and 73% were enrolled in Europe.
According to the results, radial access was used in 21.3% of patients. PCI, with drug-eluting stents, was the principal management strategy (91.1%). Eight percent of patients assigned bivalirudin also used a GPI compared with 84.8% of patients assigned heparin. Prasugrel (Effient, Eli Lilly/Daiichi Sankyo) and ticagrelor (Brilinta, AstraZeneca) were used in 18.1% of patients as a loading dose and 20.5% of patients as a maintenance dose after PCI.
The 30-day rate of major bleeding was 4.2% with bivalirudin vs. 7.8% with heparin ± GPI (RR=0.53; 95% CI, 0.43-0.66); thrombocytopenia, 1.4% vs. 2.9% (RR=0.48; 95% CI, 0.33-0.71); cardiac mortality, 2% vs. 2.9% (RR=0.7; 95% CI, 0.5-0.97). The researchers reported nonsignificant different rates of all-cause mortality, stroke, ischemia-driven revascularization and reinfarction.
Increased acute stent thrombosis was observed with bivalirudin (1.2% vs. 0.2%; RR=6.04; 95% CI, 2.55-14.31). The researchers reported nonsignificant different rates of subacute stent thrombosis between the treatment groups.
Patients assigned bivalirudin had lower rates of composite net adverse clinical events (8.8% vs. 11.9%; RR=0.74; 95% CI, 0.63-0.86).
“These findings were consistent across the two trials, and no heterogeneity was observed in important subgroups, including P2Y12 inhibitor type and vascular access site,” the researchers wrote.
“These results support the use of bivalirudin for anticoagulation of patients with STEMI undergoing primary PCI, independently of vascular access site, choice of P2Y12 inhibitor, and timing of drug initiation and discontinuation,” they concluded.
Disclosure: Several researchers report financial ties with various pharmaceutical and device companies, including The Medicines Company.
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