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Bivalirudin after primary PCI reduces 30-day risk for major bleeding, increases acute stent thrombosis risk
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The use of bivalirudin is associated with a significantly reduced 30-day risk for major bleeding after primary PCI, but it confers an increased risk for acute stent thrombosis compared with heparin, according to recent findings.
However, the elevated risk can be attenuated through continuation of a full PCI dose of bivalirudin 3 to 4 hours after the procedure, the researchers wrote.
In the meta-analysis, researchers identified five randomized trials that enrolled patients with acute STEMI undergoing primary PCI (n = 16,294) and randomly assigned those individuals to a regimen of bivalirudin or heparin.
The selected trials utilized one of two bivalirudin dosage rates for post-PCI infusion: 1.75 mg/kg/h or 0.25 mg/kg/h. Patients for whom bivalirudin was discontinued post-PCI were placed in a third group.
The study’s primary efficacy endpoint was definite acute stent thrombosis, characterized as stent thrombosis within 24 hours of primary PCI. The secondary efficacy endpoint was subacute stent thrombosis, defined as stent thrombosis less than 30 days post-primary PCI but more than 24 hours after the procedure. The primary safety endpoint was 30-day occurrence of major bleeding, which was individually defined by trial.
Stent thrombosis risk
In the direct comparison meta-analysis, the researchers found that bivalirudin was associated with an increased risk for acute stent thrombosis vs. heparin (RR = 2.36; 95% CI, 1.46-3.02); however, this risk was neutralized by the continuation of the higher dose of bivalirudin (RR = 0.9; 95% CI, 0.32-2.54). Continuation of the lower dose of bivalirudin did not achieve this effect (RR = 3.61; 95% CI, 1.17-11.13), nor did discontinuation of bivalirudin after PCI (RR = 2.79; 95% CI, 1.38-5.67). No significant heterogeneity was seen between the trials.
There was no difference between bivalirudin and heparin in subacute stent thrombosis (RR = 1.14; 95% CI, 0.53-2.42), according to the researchers.
The mixed-treatment comparison models, likewise, showed no difference in acute stent thrombosis rate between heparin and continuation of the high dose of bivalirudin (OR = 0.97; 95% CI, 0.36-2.21), but the rate of acute stent thrombosis in those treated with heparin was lower than that of those receiving a continuation of the low dose of bivalirudin (OR = 0.25; 95% CI, 0.12-0.57) or receiving no bivalirudin after PCI (OR = 0.33; 95% CI, 0.17-0.56). Treatment ranking found continuation of the high dose of bivalirudin to be the best treatment, followed closely by heparin, according to the researchers.
The direct comparison meta-analysis found that bivalirudin was associated with a reduced risk for 30-day major bleeding vs. heparin (RR = 0.53; 95% CI, 0.39-0.72), an effect that remained consistent with continued use of the high dose of bivalirudin after PCI (RR = 0.29; 95% CI, 0.16-0.53).
Future trials needed
According to the researchers, future randomized controlled trials are warranted to study the effects of a post-primary PCI bivalirudin infusion on acute stent thrombosis, CV mortality and all-cause mortality.
“In primary PCI, bivalirudin significantly decreases the 30-day risk of major bleeding at the expense of an increased risk for [acute stent thrombosis] compared to heparin. However, the increased risk for [acute stent thrombosis] may be mitigated by continuing a full PCI dose of bivalirudin 3 to 4 hours post-PCI,” the researchers wrote. “The decreased bleeding risk with bivalirudin, compared with heparin, is not compromised by this strategy.” – by Jennifer Byrne
Disclosure: One researcher reports consulting for AstraZeneca, Medtronic, Merck and Terumo.
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