Bivalirudin Effective, with Less Bleeding, During Percutaneous Coronary Interven
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A large-scale study at 233 hospitals in nine countries indicates bivalirudin is as effective, with less bleeding, as heparin plus antiplatelet drugs during percutaneous coronary intervention (PCI).
More than 6,000 patients undergoing urgent or elective stent, angioplasty or atherectomy procedures were evaluated in the study.
"Bivalirudin, with a glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitor administered in approximately 7% of patients, provided protection from peri-procedural ischaemic events that was not inferior to that of the current standard of low-dose heparin plus planned Gp IIb/IIIa blockade, with less associated major haemorrhage," report researchers led by Dr. Michael Lincoff of the Cleveland Clinic Foundation in Ohio, United States. "Bivalirudin with a provisional Gp IIb/IIa inhibitor was superior to heparin alone by an imputed comparison."
, 百拇医药
According to the investigators, these findings validate bivalirudin with selective Gp IIb/IIIa blockade "as an effective and safe anticoagulation strategy during PCI, with advantages with regard to bleeding risk, cost and ease of administration."
Prior to this study, the direct thrombin inhibitor bivalirudin was not widely tested during contemporary percutaneous coronary intervention (PCI).
The Randomised Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial took place from October 2001 through August 2002. A total of 2,999 patients were randomised to receive intravenous bivalirudin with provisional Gp IIb/IIIa inhibition, while 3,011 patients received heparin with planned Gp IIb/IIIa inhibition.
, 百拇医药
Dosage of bivalirudin was 0.75 mg/kg bolus, plus 1.75 mg/kg per hour for the duration of PCI. Heparin dosage was 65 U/kg bolus. Both groups received aspirin daily and a thienopyridine for at least 30 days post-PCI.
The primary composite end point included 30-day incidence of death, myocardial infarction (MI), urgent repeat revascularisation and in-hospital major bleeding. The secondary composite end point was 30-day incidence of death, MI and urgent repeat revascularisation.
, 百拇医药
By day 30, the primary end point was observed in 9.2% of bivalirudin patients and 10% of heparin plus Gp IIb/IIIa patients (p=0.32). The secondary end point occurred in 7.6% of bivalirudin patients and 7.1% of the heparin-plus-Gp IIb/IIIa patients (p=0.40).
"Pre-specified statistical criteria for non-inferiority to heparin plus Gp IIb/IIIa were satisfied for both end points," the researchers write.
They point out that in-hospital major bleeding was significantly reduced with bivalirudin, at 2.4%, compared with heparin plus Gp IIb/IIIa at 4.1% (p, http://www.100md.com
More than 6,000 patients undergoing urgent or elective stent, angioplasty or atherectomy procedures were evaluated in the study.
"Bivalirudin, with a glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitor administered in approximately 7% of patients, provided protection from peri-procedural ischaemic events that was not inferior to that of the current standard of low-dose heparin plus planned Gp IIb/IIIa blockade, with less associated major haemorrhage," report researchers led by Dr. Michael Lincoff of the Cleveland Clinic Foundation in Ohio, United States. "Bivalirudin with a provisional Gp IIb/IIa inhibitor was superior to heparin alone by an imputed comparison."
, 百拇医药
According to the investigators, these findings validate bivalirudin with selective Gp IIb/IIIa blockade "as an effective and safe anticoagulation strategy during PCI, with advantages with regard to bleeding risk, cost and ease of administration."
Prior to this study, the direct thrombin inhibitor bivalirudin was not widely tested during contemporary percutaneous coronary intervention (PCI).
The Randomised Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial took place from October 2001 through August 2002. A total of 2,999 patients were randomised to receive intravenous bivalirudin with provisional Gp IIb/IIIa inhibition, while 3,011 patients received heparin with planned Gp IIb/IIIa inhibition.
, 百拇医药
Dosage of bivalirudin was 0.75 mg/kg bolus, plus 1.75 mg/kg per hour for the duration of PCI. Heparin dosage was 65 U/kg bolus. Both groups received aspirin daily and a thienopyridine for at least 30 days post-PCI.
The primary composite end point included 30-day incidence of death, myocardial infarction (MI), urgent repeat revascularisation and in-hospital major bleeding. The secondary composite end point was 30-day incidence of death, MI and urgent repeat revascularisation.
, 百拇医药
By day 30, the primary end point was observed in 9.2% of bivalirudin patients and 10% of heparin plus Gp IIb/IIIa patients (p=0.32). The secondary end point occurred in 7.6% of bivalirudin patients and 7.1% of the heparin-plus-Gp IIb/IIIa patients (p=0.40).
"Pre-specified statistical criteria for non-inferiority to heparin plus Gp IIb/IIIa were satisfied for both end points," the researchers write.
They point out that in-hospital major bleeding was significantly reduced with bivalirudin, at 2.4%, compared with heparin plus Gp IIb/IIIa at 4.1% (p, http://www.100md.com