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HORIZONS-AMI: Bivalirudin vs. unfractionated heparin plus GPIIb/IIIa reduced 1-year mortality, recurrent MI in high-risk patients
Alfonso F. J Am Coll Cardiol Intv. 2010;3:803-805.
Parodi G. J Am Coll Cardiol Intv. 2010;3:796-802.
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Bivalirudin reduced 1-year mortality and recurrent MI vs. unfractionated heparin plus glycoprotein IIb/IIIa inhibitors in high-risk patients undergoing primary percutaneous coronary intervention for acute MI, study data indicated.
The HORIZONS-AMI trial featured patients classified as low, intermediate and high risk according to the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) risk score.
Of the patients (n=3,602) enrolled in the trial, 2,530 could be classified by the CADILLAC risk score, with 1,522 (60%) classified as low risk, 531 (21%) as intermediate risk and 477 (19%) as high risk. The mortality rates in the low-risk group were 0.4% in the bivalirudin arm, 1.2% in the unfractionated heparin (UFH) plus GPIIb/IIIa arm (P=.09); in the intermediate-risk group, rates were 4.2% for bivalirudin and 4.1% for UFH plus GPIIb/IIIa arm (P=.99); and in the high-risk group, rates were 8.4% in the bivalirudin arm and 15.9% in the UFH plus GPIIb/IIIa arm (P=.01).
“The reduction in mortality in patients randomized to bivalirudin as compared with UFH plus [GPIIb/IIIa] was mainly driven by a difference in mortality in the high-risk patient group, whereas no difference could be revealed in the intermediate-risk group, and only a trend favoring bivalirudin was revealed in the low-risk group,” researchers wrote in their study. Although not certain of the mechanisms involved in the benefit of bivalirudin in high-risk patients, they added, “The results of the present analysis support bivalirudin treatment as a standard of care for high-risk patients undergoing primary PCI for acute MI.”
Fernando Alfonso, MD, PhD, and Manuel Paulo, MD, both with the Cardiovascular Institute at San Carlos University Hospital in Madrid, said in an accompanying editorial that HORIZONS-AMI provided adequate guidance to optimize interventions in patients with a high risk for STEMI.
“For these patients, bivalirudin appears to be not only safer but also more effective than standard antithrombotic strategies and, therefore, should be considered the preferred option,” they concluded. “Further investigation is now warranted to assess the value of bivalirudin for patients receiving novel, more predictable and potent antiplatelet agents.”
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