By Thomas S. May
ORLANDO, FL -- May 14, 2007 -- Bivalirudin, a direct thrombin inhibitor, is as efficacious as heparin in preventing ischemic events in acute coronary syndromes, but results in significantly fewer bleeding complications, according to research presented here at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI).
To evaluate cardiac outcomes with bivalirudin versus heparin in patients with acute coronary syndromes (ACS), including patients undergoing percutaneous coronary interventions (PCI), the researchers performed a meta-analysis of five randomised, controlled trials involving a total of 25,457 patients (bivalirudin 1,5077, heparin 10,380).
Some of the trials included in the meta-analysis used unfractionated heparin while others used low molecular weight heparins, and the comparison was done between bivalirudin and group of heparins.
The investigators computed combined relative risks and the 95% confidence intervals of death, myocardial infarction, and revascularisation (bivalirudin vs. heparin) across the five studies using the Mantel-Haenszel fixed-effect model. Risks of major bleeding were calculated using the random effect model.
There were no significant differences in patient characteristics between the two groups.
An analysis of the results showed that the relative risk of death, myocardial infarction, revascularisation, and composite ischemic endpoints were similar between heparin and bivalirudin monotherapy, indicating the non-inferiority of bivalirudin versus heparin. The risk of major bleeding was significantly lower in patients receiving bivalirudin monotherapy versus those treated with heparin (P <.001).
These data suggest that bivalirudin monotherapy can play an important role as an anticoagulant in the treatment of acute coronary syndrome, according to lead investigator Sarabjeet Singh, MD, resident, department of medicine, division of cardiology, Chicago Medical School, North Chicago, Illinois, United States.
Nevertheless, whether to use it or not largely depends on local practice styles, including the use and timing of an early invasive strategy, he said.
"It is important to understand that bivalirudin does not define any new standards but gives an alternative pharmacological option that might be considered for treating ACS," Dr. Singh cautioned.
"There is still much work to be done to determine the optimal combination of drugs in the management of patients with ACS," he said.
REFERENCES:
1. Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: final report reanalysis of the Bivalirudin Angioplasty Study. Am Heart J. 2001;142:952-959.
2. Bivalirudin with planned or provisional abciximab versus low-dose heparin and abciximab during percutaneous coronary revascularization: results of the Comparison of Abciximab Complications With Hirulog for Ischemic Events Trial (CACHET). Am Heart J. 2002;143:847-853.
3. Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial). Am J Cardiol. 2004 May 1;93(9):1092-6.
4. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003 Feb 19;289(7):853-63.
5. A randomized comparison of Angiomax® (bivalirudin) versus Lovenox™ Clexane™ (enoxaparin) in patients undergoing early invasive management for acute coronary syndromes without ST-segment elevation (Acuity Trial). Lancet. 2007 Mar 17;369(9565):907-19.
[Presentation title: Non-Inferiority of Bivalirudin versus Heparin in Cardiac Outcomes Reduction but Superiority in Reduction of Bleeding in Acute Coronary Syndrome and PCI: A Meta-Analysis. Abstract A-13]
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