BRIGHT-4: Bivalirudin bests heparin in STEMI PCI with radial access
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CHICAGO — In patients with STEMI undergoing primary PCI, mostly with radial artery access, anticoagulation with bivalirudin reduced death and major bleeding at 30 days compared with heparin, according to the results of the BRIGHT-4 trial.
In BRIGHT-4, presented at the American Heart Association Scientific Sessions and simultaneously published in The Lancet, Gregg W. Stone, MD, director of academic affairs for the Mount Sinai Health System and professor of medicine (cardiology) and population health science and policy at Icahn School of Medicine at Mount Sinai, and colleagues randomly assigned 6,016 patients from China (mean age, 61 years; 78% men) with STEMI undergoing primary PCI with radial artery access to anticoagulation with bivalirudin (Hansoh Pharmaceutical Group) in the form of a bolus of 0.75 mg/kg followed by an infusion of 1.75 mg/kg per hour during the procedure and for 2 to 4 hours after the procedure, or with unfractionated heparin in the form of a bolus of 70 U/kg and additional heparin depending on activated clotting time. Glycoprotein IIb/IIIa inhibitors were not administered in either group unless there were thrombotic complications during the procedure.
Stone said during a presentation that past trials of bivalirudin vs. heparin in PCI “have had conflicting results, in part because substantial heterogeneity was present in the designs of those trials. Patients with non-STEMI and STEMI were enrolled in the trials, there was a mixture of routine vs. selective use of glycoprotein IIb/IIIa inhibitors in the heparin arm, and there was use and nonuse of post-PCI bivalirudin infusion and low dose vs. high dose. And then we transitioned over from femoral vascular access to radial access.”
BRIGHT-4 was designed to compare the two regimens that have been shown to be most likely to reduce ischemic and hemorrhagic complications, he said.
The primary endpoint was all-cause mortality or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding at 30 days.
Among the cohort, 93.1% had their PCI performed with radial access.
At 30 days, the primary endpoint occurred in 4.39% of the heparin group and 3.06% of the bivalirudin group (difference, 1.33 percentage points; 95% CI, 0.38-2.29; HR = 0.69; 95% CI, 0.53-0.91; P = .007; number needed to treat = 76), according to the researchers.
All-cause mortality at 30 days was higher in the heparin group (3.92% vs. 2.96%; HR = 0.75; 95% CI, 0.57-0.99; P = .042), as was BARC types 3 to 5 bleeding (0.8% vs. 0.17%; HR = 0.21; 95% CI, 0.08-0.54; P = .0014), Stone said during the presentation.
There were no differences between the groups in reinfarction, stroke or ischemia-driven target vessel revascularization at 30 days.
Stent thrombosis at 30 days was also higher in the heparin group (1.1% vs. 0.37%; P = .0015), Stone said.
Net adverse clinical events, defined as death, reinfarction, stroke, ischemia-driven TVR or BARC types 3 to 5 bleeding, also favored the bivalirudin group at 30 days (5.6% vs. 4.2%; HR = 0.74; 95% CI, 0.59-0.94; P = .0124), the researchers found.
“Bivalirudin should be considered the preferred regimen in the cath lab for patients with STEMI undergoing primary PCI due to reduced mortality and overall adverse outcomes,” Stone said during the presentation.
Stone also noted that although performed in China, the results should be generalizable, and that similar results were seen in the European MATRIX trial. Finally, he said, now that bivalirudin is generic, the U.S. difference in price between heparin and bivalirudin is only approximately $150.
In a discussant presentation, P. Gabriel Steg, MD, chief of the cardiology department at Hôpital Bichat, Paris, and professor of cardiology at the Université de Paris, said the trial is a “clear, unambiguous win for bivalirudin at 30 days.”
“It’s difficult to justify withholding a treatment that reduces all-cause mortality,” he said. “However, we know that bivalirudin remains slightly more complex and slightly more expensive than heparin, so it may be difficult to change practice even with these data. It will be important to have longer-term follow-up and cost-effectiveness analyses.”
Reference:
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This was a well-designed, large study in the Chinese population. The researchers followed patients acutely and out to 30 days and found lower bleeding and major adverse events with bivalirudin. Bivalirudin appeared to be safer than heparin, and this trial may prompt us to relook at this agent. Five to 10 years ago, there was a huge transition, with many physicians going back to heparin after predominantly using bivalirudin. A lot of that was driven by access-site bleeding and the cost of bivalirudin, which was a brand-name drug at the time.
In PCI with the radial approach, there was less access-site bleeding in the bivalirudin group, though a little more bleeding in other sites.
I would not say that this trial means we need to switch to bivalirudin, but it should prompt us to reexamine bivalirudin vs. heparin in our complex patients undergoing PCI. We also need to see more randomized trial evidence from other countries.
Sanger Heart & Vascular Institute/Atrium Health
Clinical Professor
Wake Forest University School of Medicine
Vice President, American College of Cardiology
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Stone GW, et al. LBS.06: Drugs and Strategies in ACS and Revascularization. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
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