WASHINGTON — Bivalirudin appears to be as safe as
standard-dose unfractionated heparin in patients with acute coronary syndrome
treated with fondaparinux before percutaneous coronary intervention, according
to results from the SWITCH III trial.
Ron Waksman, MD, associate director of the
division of cardiology at the Washington Hospital Center, and colleagues
conducted the SWITCH III trial to evaluate the safety of switching from
fondaparinux (Arixtra, GlaxoSmithKline) to unfractionated heparin or
bivalirudin (Angiomax, The Medicines Company) in patients with
non–ST-elevation ACS within 24 hours of undergoing angiography followed by
“In the US, we are interested in this situation
because fondaparinux is not approved for ACS, and bivalirudin is highly used in
the majority of cath labs,” Waksman said during a presentation. “In
Europe, we are in the opposite situation where fondaparinux is being used, is
approved and is in the guidelines for ACS, and bivalirudin is not used much.
However, this question of switching from fondaparinux to bivalirudin has not
been studied before.”
The researchers randomly assigned 100 patients
prescribed fondaparinux to bivalirudin (n=51) or heparin (n=49). There were no
deaths or fatal disease in either group. Two patients in the bivalirudin group
and none in the heparin group experienced major bleeds as defined by SWITCH III
and OASIS criteria. Additionally, no patients experienced catheter thromboses
— an especially important finding, Waksman said. Results also showed
similar safety between the two drugs for other outcomes, including access site
complications, MI, procedural complications, the need for repeat
revascularization and mortality.
Use of radial access was more common than femoral access
in both groups (68.6% vs. 31% and 67.3% vs. 32%), according to study data.
Study limitations included the small number of patients,
and radial access was used in two-thirds of patients. Nevertheless, Waksman
said the results have important implications.
“The data from this prospective multicenter trial
suggest that bivalirudin in comparison to standard-dose unfractionated heparin
has a similar safety profile in terms of peri-PCI bleeding and thrombotic
events,” Waksman said. “The length of intracatheter thrombus in the
bivalirudin group suggests that it can be safely used in ACS patients treated
with upstream fondaparinux, and we would like to replicate [these results] in
large randomized trials to establish the safety and efficacy of treating
patients with bivalirudin in this setting.” – by Melissa Foster
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Disclosure: Dr. Waksman has received consulting fees from Abbott Vascular, AstraZeneca, Atrium Medical Corporation, Boston Scientific Corporation, Bristol-Myers Squibb, Daiichi Sankyo, InfraReDx Inc., Medtronic, Merck, Sanofi Aventis, The Medicines Company and Volcano Therapeutics. He has also received honoraria from Abbott Laboratories, Boston Scientific, Medtronic and Merck.