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

BackgroundThe optimal antithrombotic therapy in patients with ST‐segment‐elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) remains a matter of debate. This updated meta‐analysis investigated the impact of (1) bivalirudin (with and without prolonged infusion)...

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Main Authors: Gregor Fahrni, Mathias Wolfrum, Giovanni Luigi De Maria, Adrian P. Banning, Umberto Benedetto, Rajesh K. Kharbanda
Format: Article
Language:English
Published: Wiley 2016-07-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Subjects:
Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.116.003515
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author Gregor Fahrni
Mathias Wolfrum
Giovanni Luigi De Maria
Adrian P. Banning
Umberto Benedetto
Rajesh K. Kharbanda
author_facet Gregor Fahrni
Mathias Wolfrum
Giovanni Luigi De Maria
Adrian P. Banning
Umberto Benedetto
Rajesh K. Kharbanda
author_sort Gregor Fahrni
collection DOAJ
description BackgroundThe optimal antithrombotic therapy in patients with ST‐segment‐elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) remains a matter of debate. This updated meta‐analysis investigated the impact of (1) bivalirudin (with and without prolonged infusion) and (2) prolonged PCI‐dose (1.75 mg/hg per hour) bivalirudin infusion compared with conventional antithrombotic therapy on clinical outcomes in patients undergoing primary PCI. Methods and ResultsEligible randomized trials were searched through MEDLINE, EMBASE, 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‐IIb/IIIa inhibitor) was associated with reduction in major bleeding (odds ratio [OR]: 0.65, 95% CI: 0.48–0.88, P=0.006, derived from all 6 trials), increase in acute stent thrombosis (OR: 2.75, 95% CI: 1.46–5.18, P=0.002, 5 trials), and lower rate of all‐cause mortality (OR: 0.81, 95% CI: 0.67–0.98, P=0.03, 6 trials) as well as cardiac mortality (OR: 0.69, 95% CI: 0.55–0.87, P=0.001, 5 trials). The incidence of acute stent thrombosis did not differ between the prolonged PCI‐dose bivalirudin and comparator group (OR: 0.81, 95% CI: 0.27–2.46, P=0.71, 3 trials), whereas the risk of bleeding was reduced despite treatment with high‐dose bivalirudin infusion (OR: 0.28, 95% CI: 0.13–0.60, P=0.001, 3 trials). ConclusionsBivalirudin (with and without prolonged infusion) compared with conventional antithrombotic therapy in ST‐segment‐elevation myocardial infarction patients undergoing primary PCI reduces major bleeding and death, but increases the rate of acute stent thrombosis. However, prolonging the bivalirudin infusion at PCI‐dose (1.75 mg/kg per hour) for 3 hours eliminates the excess risk of acute stent thrombosis, while maintaining the bleeding benefits.
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spelling doaj.art-d72fd4fd23d24f0f9687b1832368cd852022-12-21T23:14:52ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802016-07-015710.1161/JAHA.116.003515Prolonged High‐Dose Bivalirudin Infusion Reduces Major Bleeding Without Increasing Stent Thrombosis in Patients Undergoing Primary Percutaneous Coronary Intervention: Novel Insights From an Updated Meta‐AnalysisGregor Fahrni0Mathias Wolfrum1Giovanni Luigi De Maria2Adrian P. Banning3Umberto Benedetto4Rajesh K. Kharbanda5Oxford Heart Centre, The John Radcliffe Hospital, Oxford University Hospitals, Oxford, UKOxford Heart Centre, The John Radcliffe Hospital, Oxford University Hospitals, Oxford, UKOxford Heart Centre, The John Radcliffe Hospital, Oxford University Hospitals, Oxford, UKOxford Heart Centre, The John Radcliffe Hospital, Oxford University Hospitals, Oxford, UKBristol Heart Institute, School of Clinical Sciences, University of Bristol, UKOxford Heart Centre, The John Radcliffe Hospital, Oxford University Hospitals, Oxford, UKBackgroundThe optimal antithrombotic therapy in patients with ST‐segment‐elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) remains a matter of debate. This updated meta‐analysis investigated the impact of (1) bivalirudin (with and without prolonged infusion) and (2) prolonged PCI‐dose (1.75 mg/hg per hour) bivalirudin infusion compared with conventional antithrombotic therapy on clinical outcomes in patients undergoing primary PCI. Methods and ResultsEligible randomized trials were searched through MEDLINE, EMBASE, 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‐IIb/IIIa inhibitor) was associated with reduction in major bleeding (odds ratio [OR]: 0.65, 95% CI: 0.48–0.88, P=0.006, derived from all 6 trials), increase in acute stent thrombosis (OR: 2.75, 95% CI: 1.46–5.18, P=0.002, 5 trials), and lower rate of all‐cause mortality (OR: 0.81, 95% CI: 0.67–0.98, P=0.03, 6 trials) as well as cardiac mortality (OR: 0.69, 95% CI: 0.55–0.87, P=0.001, 5 trials). The incidence of acute stent thrombosis did not differ between the prolonged PCI‐dose bivalirudin and comparator group (OR: 0.81, 95% CI: 0.27–2.46, P=0.71, 3 trials), whereas the risk of bleeding was reduced despite treatment with high‐dose bivalirudin infusion (OR: 0.28, 95% CI: 0.13–0.60, P=0.001, 3 trials). ConclusionsBivalirudin (with and without prolonged infusion) compared with conventional antithrombotic therapy in ST‐segment‐elevation myocardial infarction patients undergoing primary PCI reduces major bleeding and death, but increases the rate of acute stent thrombosis. However, prolonging the bivalirudin infusion at PCI‐dose (1.75 mg/kg per hour) for 3 hours eliminates the excess risk of acute stent thrombosis, while maintaining the bleeding benefits.https://www.ahajournals.org/doi/10.1161/JAHA.116.003515bivalirudinmeta‐analysismyocardial infarctionpercutaneous coronary intervention
spellingShingle Gregor Fahrni
Mathias Wolfrum
Giovanni Luigi De Maria
Adrian P. Banning
Umberto Benedetto
Rajesh K. Kharbanda
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
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
bivalirudin
meta‐analysis
myocardial infarction
percutaneous coronary intervention
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic bivalirudin
meta‐analysis
myocardial infarction
percutaneous coronary intervention
url https://www.ahajournals.org/doi/10.1161/JAHA.116.003515
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