Registry Questions Superiority of Bivalirudin Over Heparin Alone in NSTE-ACS

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In patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI), bivalirudin may not be superior to heparin as a bleeding avoidance strategy in the absence of glycoprotein IIb/IIIa inhibitors (GPIs), according to a large registry study presented May 21, 2013 at EuroPCR in Paris, France.

Oskar Angerås, MD, of Sahlgrenska University Hospital (Gothenburg, Sweden), outlined a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) that culled data from 41,537 consecutive patients with NSTE-ACS not receiving GPIs who underwent PCI from 2005 to 2011 and received heparin (n = 31,351) or bivalirudin (n = 10,186).

After propensity-score adjustment, 30-day mortality favored heparin (adjusted OR 1.35). The difference was reduced to a trend in favor of heparin after instrumental variable analysis to adjust for unknown confounders (adjusted OR 1.14).

Subgroup analysis maintained nonsignificant support for heparin, with the exception of female patients, those with diabetes, and those who underwent femoral PCI (table 1).

Table 1. Subgroup Analyses: Bivalirudin vs. Heparin Alone

Take Care with Interpretation

“One should be very careful when interpreting the results, however none of our models show that treatment with bivalirudin improves outcome,” Dr. Angerås said in a prepared statement. “The results therefore question the superiority of bivalirudin to heparin in the absence of GP IIb/IIIa blockade in patients with NSTE-ACS undergoing PCI. The clinical implication is that if we use heparin alone, we can be assured that it’s enough. For those using bivalirudin, switching to heparin achieves similar outcomes and will reduce the cost of procedures.”

Given the results, Dr. Angerås said his group has initiated the registry-based randomized VALIDATE-SWEDEHEART trial comparing bivalirudin to heparin in patients pretreated with novel ADP-receptor blockers, with the aim of recruiting a total of 6,000 patients. The study will look at mortality, MI, or major bleeding at 180 days.

Study Details

Mean age was 67.4 ± 11 years in the heparin group and 68.5 ± 11 years in the bivalirudin group. Patients treated with bivalirudin were more often female and more likely to have positive biomarkers. Bivalirudin patients were also less likely to have been treated for hypertension or hyperlipidemia. Patients treated with heparin alone were more likely to have had a prior PCI, been former smokers, or been treated with clopidogrel or warfarin. Propensity-score matching took these factors into account.

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Source:
Angerås O. Heparin versus bivalirudin in patients with non ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention: A report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Presented at: EuroPCR; May 22, 2013; Paris, France.

 

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