Meta-analysis: Less Bleeding, More Stent Thrombosis with Bivalirudin vs. Heparin After PCI

Bivalirudin does not reduce 30-day mortality rates compared with heparin in patients undergoing PCI without planned use of glycoprotein IIb/IIIa inhibitors (GPIs), according to a meta-analysis presented Sunday at TCT 2014. There was a lower risk of major bleeding with bivalirudin, but also an increased risk of acute stent thrombosis.

Salvatore Cassese, MD, of Deutsches Herzzentrum in Munich, Germany, and colleagues analyzed data on 18,065 PCI patients randomized to receive bivalirudin (n=9,033) or heparin (n=9,032). GPIs were given only as a provisional or bailout measure.

Although mortality, MI, and urgent target lesion revascularization (TVR) occurred at similar rates between the two groups, major bleeding was less frequent and stent thrombosis more common among the patients who received bivalirudin (see Table).

Table. Outcomes at 30 Days, Bivalirudin vs. Heparin

Although the risk of definite stent thrombosis was higher in the bivalirudin group for the full 30-day period, the risk was particularly great for acute stent thrombosis (OR 3.48; 95% CI, 1.66-7.28; P<.001).

“The main supportive evidence in favor of bivalirudin has come from earlier comparisons versus heparin plus planned GPIs,” Cassese told TCT Daily. “Since GPI use for patients undergoing PCI is nowadays recommended primarily as a bailout rather than a planned routine strategy, the applicability of these results in the current era is open to question.”

The lack of a mortality benefit with bivalirudin conflicts with results of the HORIZONS-AMI trial, he noted, though in that study GPIs were routinely given to heparin patients.

While consistent with earlier research showing a reduction in major bleeding at 30 days, the meta-analysis also included sensitivity analyses that indicate the advantage is more evident when higher doses of heparin are used as the comparator. “In other words,” Cassese explained, “bivalirudin shows no advantage over the currently used standard regimen of heparin in terms of bleeding.”

According to Cassese, more data are clearly needed in this field, especially in view of recent progress with adjunctive antithrombotic therapies for PCI patients. Still, he said, the higher risk of acute stent thrombosis “may potentially represent the major drawback of bivalirudin.” Even in the current era, full antiplatelet inhibition does not occur until some hours following loading dose administration, which means insufficient antithrombotic protection immediately after revascularization could expose patients to excess risk. 

“The objective of using an antithrombotic drug during stenting remains the prevention of stent thrombosis,” Cassese said. “However, in cases where two anticoagulants show similar antithrombotic efficacy, then all clinicians certainly would prefer the drug that causes less bleeding.” 

Disclosures:

• Cassese reports no relevant conflicts of interest.