> Details
Fahrni, Gregor;
Wolfrum, Mathias;
De Maria, Giovanni Luigi;
Banning, Adrian P.;
Benedetto, Umberto;
Kharbanda, Rajesh K.
Prolonged High‐Dose Bivalirudin Infusion Reduces Major Bleeding Without Increasing Stent Thrombosis in Patients Undergoing Primary Percutaneous Coronary Intervention: Novel Insights From an Updated Meta‐Analysis
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- Media type: E-Article
- Title: Prolonged High‐Dose Bivalirudin Infusion Reduces Major Bleeding Without Increasing Stent Thrombosis in Patients Undergoing Primary Percutaneous Coronary Intervention: Novel Insights From an Updated Meta‐Analysis
- Contributor: Fahrni, Gregor; Wolfrum, Mathias; De Maria, Giovanni Luigi; Banning, Adrian P.; Benedetto, Umberto; Kharbanda, Rajesh K.
- imprint: Ovid Technologies (Wolters Kluwer Health), 2016
- Published in: Journal of the American Heart Association
- Language: English
- DOI: 10.1161/jaha.116.003515
- ISSN: 2047-9980
- Keywords: Cardiology and Cardiovascular Medicine
- Origination:
- Footnote:
- Description: <jats:sec xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en"> The optimal antithrombotic therapy in patients with <jats:styled-content style="fixed-case">ST</jats:styled-content> ‐segment‐elevation myocardial infarction undergoing primary percutaneous coronary intervention ( <jats:styled-content style="fixed-case">PCI</jats:styled-content> ) remains a matter of debate. This updated meta‐analysis investigated the impact of (1) bivalirudin (with and without prolonged infusion) and (2) prolonged <jats:styled-content style="fixed-case">PCI</jats:styled-content> ‐dose (1.75 mg/hg per hour) bivalirudin infusion compared with conventional antithrombotic therapy on clinical outcomes in patients undergoing primary <jats:styled-content style="fixed-case">PCI</jats:styled-content> . </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> Eligible randomized trials were searched through <jats:styled-content style="fixed-case">MEDLINE</jats:styled-content> , <jats:styled-content style="fixed-case">EMBASE</jats:styled-content> , Cochrane database, and proceedings of major congresses. Prespecified outcomes were major bleeding (thrombolysis in myocardial infarction major and Bleeding Academic Research Consortium 3–5), acute stent thrombosis, as well as all‐cause and cardiac mortality at 30 days. Six randomized trials (n=17 294) were included. Bivalirudin compared with heparin (+/− glycoprotein‐ <jats:styled-content style="fixed-case">II</jats:styled-content> b/ <jats:styled-content style="fixed-case">III</jats:styled-content> a inhibitor) was associated with reduction in major bleeding (odds ratio [ <jats:styled-content style="fixed-case">OR</jats:styled-content> ]: 0.65, 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> : 0.48–0.88, <jats:italic>P</jats:italic> =0.006, derived from all 6 trials), increase in acute stent thrombosis ( <jats:styled-content style="fixed-case">OR</jats:styled-content> : 2.75, 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> : 1.46–5.18, <jats:italic>P</jats:italic> =0.002, 5 trials), and lower rate of all‐cause mortality ( <jats:styled-content style="fixed-case">OR</jats:styled-content> : 0.81, 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> : 0.67–0.98, <jats:italic>P</jats:italic> =0.03, 6 trials) as well as cardiac mortality ( <jats:styled-content style="fixed-case">OR</jats:styled-content> : 0.69, 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> : 0.55–0.87, <jats:italic>P</jats:italic> =0.001, 5 trials). The incidence of acute stent thrombosis did not differ between the prolonged <jats:styled-content style="fixed-case">PCI</jats:styled-content> ‐dose bivalirudin and comparator group ( <jats:styled-content style="fixed-case">OR</jats:styled-content> : 0.81, 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> : 0.27–2.46, <jats:italic>P</jats:italic> =0.71, 3 trials), whereas the risk of bleeding was reduced despite treatment with high‐dose bivalirudin infusion ( <jats:styled-content style="fixed-case">OR</jats:styled-content> : 0.28, 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> : 0.13–0.60, <jats:italic>P</jats:italic> =0.001, 3 trials). </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en"> Bivalirudin (with and without prolonged infusion) compared with conventional antithrombotic therapy in <jats:styled-content style="fixed-case">ST</jats:styled-content> ‐segment‐elevation myocardial infarction patients undergoing primary <jats:styled-content style="fixed-case">PCI</jats:styled-content> reduces major bleeding and death, but increases the rate of acute stent thrombosis. However, prolonging the bivalirudin infusion at <jats:styled-content style="fixed-case">PCI</jats:styled-content> ‐dose (1.75 mg/kg per hour) for 3 hours eliminates the excess risk of acute stent thrombosis, while maintaining the bleeding benefits. </jats:p> </jats:sec>
- Access State: Open Access