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ACS Patients Benefit From Bivalirudin During PCI, Pooled Data Show

— Risks can be mitigated with infusion strategy, patient-level meta-analysis finds

Ƶ MedicalToday

Bivalirudin (Angiomax) prevailed for periprocedural anticoagulation during percutaneous coronary intervention (PCI) in acute myocardial infarction (MI), according to a patient-level meta-analysis.

Among 15,254 patients with ST-elevation myocardial infarction (STEMI), those randomized to bivalirudin instead of heparin had significantly lower 30-day rates of cardiac death (2.1% vs 2.7%, adjusted HR 0.72, 95% CI 0.57-0.91) and serious bleeding (3.5% vs 6.0%, adjusted HR 0.57, 95% CI 0.47-0.68), reported Gregg Stone, MD, of Icahn School of Medicine at Mount Sinai and the Cardiovascular Research Foundation (CRF) in New York City.

In addition, bivalirudin use trended toward reduced all-cause deaths (2.5% vs 2.9%, adjusted HR 0.80, 95% CI 0.64-1.01), Stone said at this year's TCT Connect meeting, hosted virtually by CRF.

The tradeoff was greater risk of MI (2.4% vs 1.7%, adjusted HR 1.29, 95% CI 1.02-1.64) and stent thrombosis (1.7% vs 1.2%, adjusted HR 1.45, 95% CI 1.05-1.91).

However, a strategy of high-dose infusion for approximately 2 hours after PCI mitigated these risks, said Stone, noting that approximately 60% of patients had post-PCI bivalirudin infusions.

"I didn't see what that did to the bleeding benefit, but assuming that was still preserved, then it seems like we should alter how we use bivalirudin. That will require some education and changes in workflow, though," commented Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital and Harvard Medical School in Boston.

In 12,155 non-STEMI patients, bivalirudin was associated with a reduction in serious bleeding (3.3% vs 5.3%, adjusted HR 0.63, 95% CI 0.52-0.76). Mortality, MI, and stent thrombosis rates were not affected by choice of bivalirudin vs heparin.

"This very large, well-done meta-analysis supports the use of bivalirudin, particularly in STEMI," Bhatt said. "I was convinced after , but I do realize many interventionalists, especially with radial access, have gravitated back to unfractionated heparin due to low cost, familiarity, and ease of use."

"The findings support the role of bivalirudin in patients with ACS [acute coronary syndrome], particularly those with STEMI," agreed Dominick Angiolillo, MD, PhD, of the University of Florida College of Medicine-Jacksonville.

The investigators had pooled patient-level data from several randomized trials comparing periprocedural anticoagulation with bivalirudin vs heparin, being the oldest (published in 2006) and the newest (published in 2017).

Stone maintained that these trials reflect contemporary practice, which has seen the rise of radial access, potent P2Y12 inhibitors such as cangrelor, and glycoprotein IIb/IIIa inhibitors in the past decade.

Bivalirudin appeared to reduce non-access site bleeding in STEMI and non-STEMI patients alike, which Bhatt highlighted as relevant to radial procedures.

The had shown that the ischemic prevention benefits of cangrelor were consistent regardless of the anticoagulant used.

A trial comparing unfractionated heparin plus cangrelor vs bivalirudin alone would be important for contemporary practice, Angiolillo suggested.

  • author['full_name']

    Nicole Lou is a reporter for Ƶ, where she covers cardiology news and other developments in medicine.

Disclosures

Stone had no relevant disclosures.

Bhatt reported previously receiving research funding from The Medicines Company.

Primary Source

TCT Connect

Stone GW, et al "Individual patient data pooled analysis of randomized trials of bivalirudin versus heparin in acute myocardial infarction" TCT 2020.