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Bivalirudin versus unfractionated heparin: a meta-analysis of patients receiving percutaneous coronary intervention for acute coronary syndromes.

Farag M, Gorog DA, Prasad A, Srinivasan M - Open Heart (2015)

Bottom Line: In the setting of percutaneous coronary intervention (PCI) for ACS, bivalirudin appears superior to unfractionated heparin (UFH), driven by reduced major bleeding.The reduction in major bleeding with bivalirudin was not related to vascular access site.Bivalirudin increases the risk of acute ST in STEMI, but may confer an advantage over UFH in NSTE-ACS while undergoing PCI, reducing major bleeding without an increase in ST.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology , East and North Hertfordshire NHS Trust , Hertfordshire , UK ; Postgraduate Medical School, University of Hertfordshire , Hertfordshire , UK.

ABSTRACT

Objective: Acute coronary syndrome (ACS) encompasses ST segment elevation myocardial infarction (STEMI), with generally high thrombus burden and non-ST segment elevation ACS (NSTE-ACS), with lower thrombus burden. In the setting of percutaneous coronary intervention (PCI) for ACS, bivalirudin appears superior to unfractionated heparin (UFH), driven by reduced major bleeding. Recent trials suggest that the benefit of bivalirudin may be reduced with use of transradial access and evolution in antiplatelet therapy. Moreover, a differential role of bivalirudin in ACS cohorts is unknown.

Methods: A meta-analysis of randomised trials comparing bivalirudin and UFH in patients with ACS receiving PCI, with separate analyses in STEMI and NSTE-ACS groups. Overall estimates of treatment effect were calculated with random-effects model.

Results: In 5 trials of STEMI (10 358 patients), bivalirudin increased the risk of acute stent thrombosis (ST) (OR 3.62; CI 1.95 to 6.74; p<0.0001) compared with UFH. Bivalirudin reduced the risk of major bleeding only when compared with UFH plus planned glycoprotein IIb/IIIa inhibitors (GPI) (OR 0.49; CI 0.36 to 0.67; p<0.00001). In 14 NSTE-ACS trials (25 238 patients), there was no difference between bivalirudin and UFH in death, myocardial infarction or ST. However, bivalirudin reduced the risk of major bleeding compared with UFH plus planned GPI (OR 0.52; CI 0.43 to 0.62; p<0.00001), or UFH plus provisional GPI (OR 0.68; CI 0.46 to 1.01; p=0.05). The reduction in major bleeding with bivalirudin was not related to vascular access site.

Conclusions: Bivalirudin increases the risk of acute ST in STEMI, but may confer an advantage over UFH in NSTE-ACS while undergoing PCI, reducing major bleeding without an increase in ST.

No MeSH data available.


Related in: MedlinePlus

Major bleeding with bivalirudin versus unfractionated heparin (UFH) in predominantly non-ST segment elevation acute coronary syndrome (NSTE-ACS) studies; (A) glycoprotein IIb/IIIa inhibitors (GPI) predominantly provisional in the bivalirudin arm versus planned use in the heparin arm, (B) provisional GPI use in both arms, and (C) planned GPI use in both arms.
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OPENHRT2015000258F5: Major bleeding with bivalirudin versus unfractionated heparin (UFH) in predominantly non-ST segment elevation acute coronary syndrome (NSTE-ACS) studies; (A) glycoprotein IIb/IIIa inhibitors (GPI) predominantly provisional in the bivalirudin arm versus planned use in the heparin arm, (B) provisional GPI use in both arms, and (C) planned GPI use in both arms.

Mentions: In NSTE-ACS, there was no difference between bivalirudin and UFH in the risk of death (OR 0.96; CI 0.64 to 1.45; p=0.86), MI (OR 1.09; CI 0.98 to 1.21; p=0.11), or any ST (OR 1.20; CI 0.84 to 1.70; p=0.31) (figure 4). Two NSTE-ACS trials reported no significant difference between bivalirudin and UFH in the risk of acute and subacute ST.2125 Bivalirudin plus provisional GPI reduced the risk of major bleeding compared with UFH plus planned GPI (OR 0.52; CI 0.43 to 0.62; p<0.00001) (figure 5A). Also, bivalirudin reduced the risk of major bleeding compared with UFH, with provisional use of GPI in both arms (OR 0.68; CI 0.46 to 1.01; p=0.05) (figure 5B). However, there was no difference in the risk of major bleeding when either drug was combined with planned GPI (OR 0.94; CI 0.57 to 1.53; p=0.79) (figure 5C). The results observed in NSTE-ACS were also observed within the group of trials that enrolled patients predominantly with NSTEMI (see online supplementary figure S4).


Bivalirudin versus unfractionated heparin: a meta-analysis of patients receiving percutaneous coronary intervention for acute coronary syndromes.

Farag M, Gorog DA, Prasad A, Srinivasan M - Open Heart (2015)

Major bleeding with bivalirudin versus unfractionated heparin (UFH) in predominantly non-ST segment elevation acute coronary syndrome (NSTE-ACS) studies; (A) glycoprotein IIb/IIIa inhibitors (GPI) predominantly provisional in the bivalirudin arm versus planned use in the heparin arm, (B) provisional GPI use in both arms, and (C) planned GPI use in both arms.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4593234&req=5

OPENHRT2015000258F5: Major bleeding with bivalirudin versus unfractionated heparin (UFH) in predominantly non-ST segment elevation acute coronary syndrome (NSTE-ACS) studies; (A) glycoprotein IIb/IIIa inhibitors (GPI) predominantly provisional in the bivalirudin arm versus planned use in the heparin arm, (B) provisional GPI use in both arms, and (C) planned GPI use in both arms.
Mentions: In NSTE-ACS, there was no difference between bivalirudin and UFH in the risk of death (OR 0.96; CI 0.64 to 1.45; p=0.86), MI (OR 1.09; CI 0.98 to 1.21; p=0.11), or any ST (OR 1.20; CI 0.84 to 1.70; p=0.31) (figure 4). Two NSTE-ACS trials reported no significant difference between bivalirudin and UFH in the risk of acute and subacute ST.2125 Bivalirudin plus provisional GPI reduced the risk of major bleeding compared with UFH plus planned GPI (OR 0.52; CI 0.43 to 0.62; p<0.00001) (figure 5A). Also, bivalirudin reduced the risk of major bleeding compared with UFH, with provisional use of GPI in both arms (OR 0.68; CI 0.46 to 1.01; p=0.05) (figure 5B). However, there was no difference in the risk of major bleeding when either drug was combined with planned GPI (OR 0.94; CI 0.57 to 1.53; p=0.79) (figure 5C). The results observed in NSTE-ACS were also observed within the group of trials that enrolled patients predominantly with NSTEMI (see online supplementary figure S4).

Bottom Line: In the setting of percutaneous coronary intervention (PCI) for ACS, bivalirudin appears superior to unfractionated heparin (UFH), driven by reduced major bleeding.The reduction in major bleeding with bivalirudin was not related to vascular access site.Bivalirudin increases the risk of acute ST in STEMI, but may confer an advantage over UFH in NSTE-ACS while undergoing PCI, reducing major bleeding without an increase in ST.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology , East and North Hertfordshire NHS Trust , Hertfordshire , UK ; Postgraduate Medical School, University of Hertfordshire , Hertfordshire , UK.

ABSTRACT

Objective: Acute coronary syndrome (ACS) encompasses ST segment elevation myocardial infarction (STEMI), with generally high thrombus burden and non-ST segment elevation ACS (NSTE-ACS), with lower thrombus burden. In the setting of percutaneous coronary intervention (PCI) for ACS, bivalirudin appears superior to unfractionated heparin (UFH), driven by reduced major bleeding. Recent trials suggest that the benefit of bivalirudin may be reduced with use of transradial access and evolution in antiplatelet therapy. Moreover, a differential role of bivalirudin in ACS cohorts is unknown.

Methods: A meta-analysis of randomised trials comparing bivalirudin and UFH in patients with ACS receiving PCI, with separate analyses in STEMI and NSTE-ACS groups. Overall estimates of treatment effect were calculated with random-effects model.

Results: In 5 trials of STEMI (10 358 patients), bivalirudin increased the risk of acute stent thrombosis (ST) (OR 3.62; CI 1.95 to 6.74; p<0.0001) compared with UFH. Bivalirudin reduced the risk of major bleeding only when compared with UFH plus planned glycoprotein IIb/IIIa inhibitors (GPI) (OR 0.49; CI 0.36 to 0.67; p<0.00001). In 14 NSTE-ACS trials (25 238 patients), there was no difference between bivalirudin and UFH in death, myocardial infarction or ST. However, bivalirudin reduced the risk of major bleeding compared with UFH plus planned GPI (OR 0.52; CI 0.43 to 0.62; p<0.00001), or UFH plus provisional GPI (OR 0.68; CI 0.46 to 1.01; p=0.05). The reduction in major bleeding with bivalirudin was not related to vascular access site.

Conclusions: Bivalirudin increases the risk of acute ST in STEMI, but may confer an advantage over UFH in NSTE-ACS while undergoing PCI, reducing major bleeding without an increase in ST.

No MeSH data available.


Related in: MedlinePlus