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A registry analysis confirms what was first seen in the randomized HORIZONS-AMI study— that ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) fare better with bivalirudin than heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). The study, published in the January 2012 issue of Circulation: Cardiovascular Quality and Outcomes, also demonstrates that bivalirudin is more cost effective.

Duane S. Pinto, MD, MPH, of Harvard Medical School (Boston, MA), and colleagues used the nationwide Premier hospital database to identify 59,917 STEMI admissions between January 1, 2004, and March 31, 2008, during which patients underwent primary PCI with use of bivalirudin or heparin plus a GPI. The investigators propensity-matched in a 1:3 ratio patients who were given bivalirudin (n = 5,329) with those who received heparin plus a GPI (n = 15,987) to compare in-hospital outcomes and cost.

In-Hospital Death, Bleeding, Cost All Lower with Bivalirudin

In-hospital death, the primary outcome, was reduced in the bivalirudin arm compared with the heparin plus GPI arm, as were various measures of bleeding. In addition, bivalirudin-treated patients had shorter hospital stays and lower hospital costs (table 1).

Table 1. In-Hospital Clinical and Economic Outcomes

The findings echo those of the HORIZONS-AMI trial, but “randomized trials are a restricted portion of the population who undergo treatment for STEMI, so looking at whether the outcomes were similar in a less restrictive population” was an important goal of this study, Dr. Pinto told TCTMD in a telephone interview.

Another crucial element of this study was its economic analysis. “These types of studies are very useful in an era of limited resources” said Dr. Pinto. “[They] help us as physicians determine what makes the most economic sense for our patients.”

Limitations of Database Analysis

But there are limitations to an administrative database study, Dr. Pinto noted. “We were restricted to in-hospital events,” he said, “but there was likely a [longer-term] reduction in mortality associated with bivalirudin.”

Another issue is lack of clinical detail, Dr. Pinto commented. For example, the researchers did not know the timing of GPI administration. “Sometimes they could be for bailout indications or they could be given prophylactically. We only know that they were given,” he specified, adding that “in the era of newer oral antiplatelet medications like prasugrel and ticagrelor, we don’t know if the outcomes will be similar. Other [changing] trends include the increasing use in the United States of radial [PCI, which reduces access-site bleeding]. We don’t know what that effect may be for STEMI patients. So, there’s more work to be done.”

Strong Endorsement for Bivalirudin

Despite such uncertainties, other experts are convinced that bivalirudin is the way to go, at least for now.

“With a class I level of evidence B recommendation, bivalirudin has the highest recommendation for use in primary PCI in STEMI in both the U.S. and European guidelines,” said Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), in an e-mail communication with TCTMD. Dr. Stone served as principal investigator for HORIZONS-AMI.

“These new data confirm that bivalirudin prevents bleeding, saves lives, and is less costly than the previous standard of care (heparin plus GPIs),” he continued. “Thus, bivalirudin should be widely adopted as the new standard of care in patients with STEMI undergoing primary PCI. Those not using this regimen are disadvantaging their patients.”

Deepak L. Bhatt, MD, of Brigham and Women's Hospital (Boston, MA), offered a similar assessment.

"Though not randomized, this is a carefully done, propensity-matched observational analysis. The authors find that bivalirudin use (versus heparin plus a GPI) is associated with lower mortality, lower bleeding, and lower cost—the trifecta that everyone is shooting for,” he wrote in an e-mail communication with TCTMD. “Even if one is skeptical about the significantly lower mortality with bivalirudin seen in this nonrandomized dataset, it certainly seems unlikely there was higher mortality. The lower bleeding and cost with bivalirudin versus GPIs are consistent with several other analyses and are difficult to dispute at this time.

“The message from the present study is qualitatively similar to that from the randomized HORIZONS-AMI data. The fact that this large real-world analysis parallels the clinical trial analysis is very reassuring with respect to using bivalirudin in primary PCI,” he concluded.

 

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Source:
Pinto DS, Ogbonnaya A, Sherman SA, et al. Bivalirudin therapy is associated with improved clinical and economic outcomes in ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention: Results from an observational database. Circ Cardiovasc Qual Outcomes. 2012;5:52-61.

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• HORIZONS AMI at Two Years: Taxus, Bivalirudin Maintain Their Advantage in STEMI Patients
• HORIZONS-AMI Substudies: Bivalirudin Benefits Vary Among Patient Subgroups
• Switching to Bivalirudin Effective After Early Heparin Therapy in STEMI Patients