Upstream Bivalirudin Best in NSTE-ACS Patients With Planned Invasive Strategy

 

Bivalirudin alone appears to be the best anticoagulation option for moderate- and high-risk non-ST-segment elevation (NSTE)-ACS patients with a planned early invasive strategy during the run-up phase to potential intervention, according to a substudy of the ACUITY trial published online Sep 2, 2015, ahead of print in Catheterization and Cardiovascular Interventions.

Upstream Bivalirudin Best in NSTE-ACS Patients With Planned Invasive Strategy

Bivalirudin monotherapy “during the upstream medical therapy only phase (prior to PCI, CABG or drug discontinuation) results in the lowest rates of major bleeding and NACE, with comparable suppression of adverse ischemic events compared with either heparin with or without a [glycoprotein IIb/IIIa inhibitor (GPI)], or bivalirudin with a GPI,” Tobias Geisler, MD, of University Hospital Tübingen (Tübingen, Germany), and colleagues write.

In the main ACUITY trial, 13,819 ACS patients were randomized to 1 of 3 regimens prior to an early invasive strategy: heparin plus GPI, bivalirudin plus GPI, or bivalirudin alone (with bailout GPI if necessary). Patients assigned to a GPI arm were randomized again to upstream GPI initiation or use only if triaged to PCI.

Early invasive treatment consisted of angiography (98.9%) followed by PCI in 56.4% and CABG in 11.1%; the remaining 32.5% received conservative management.

Thus, during the medicine-only phase, the 4 regimens were:

  • Heparin alone (n = 2,309)  
  • Heparin plus GPI (n = 2,294)  
  • Bivalirudin alone (n = 6,905) 
  • Bivalirudin plus GPI (n = 2,311) 

For the current substudy, the researchers looked at how the upstream medical management phase impacted outcomes during this period. Median duration of antithrombin therapy was 6.5 hours.

Least Bleeding Seen With Bivalirudin Alone

Overall, rates of MACE (all-cause death, MI, and unplanned revascularization for ischemia; primary endpoint) were similar across the medical regimens, while rates of on-treatment major bleeding and NACE (MACE or non-CABG major bleeding) were lowest in the bivalirudin-alone group (table 1).

 Table 1.  Outcomes in NSTE-ACS Patients During Medical Therapy Phase

The findings of this post hoc subgroup analysis should be considered hypothesis generating, Dr. Geisler and colleagues caution. Event rates during the short upstream medical therapy period were modest and, according to the study authors, were not sufficiently powered to detect small differences in ischemic events or mortality.

However, an important consideration bolstering the clinical implications of these findings, they say, is that clopidogrel and ticlopidine were the only ADP antagonists available during enrollment in ACUITY. “In the current era of more potent ADP antagonists (prasugrel, ticagrelor), non-CABG-related bleeding rates have increased, and as such the differences observed in the present study may be even more relevant,” the researchers emphasize.

Additionally, the study authors note , the data are in line with current American College of Cardiology Foundation/American Heart Association guidelines, which do not support routine upstream therapy with GPIs.

Note: Study coauthors Gregg W. Stone, MD, and Roxana Mehran, MD, are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.


Source:
Geisler T, Droppa M, Gawaz M, et al. Impact of anticoagulation regimen prior to revascularization in patients with non-ST-segment elevation acute coronary syndromes: the ACUITY trial. Catheter Cardiovasc Intv. 2015;Epub ahead of print.

Disclosures:

  • Dr. Geisler reports receiving lecture honoraria from Bayer Health Care, Eli Lilly/Daiichi Sankyo, and The Medicines Company, and a restricted grant from Eli Lilly/Daiichi Sankyo.

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