NEW YORK (Reuters Health) – Combined bivalirudin (Angiomax) and vascular closure devices are better to staunch bleeding after percutaneous coronary intervention (PCI) than either strategy alone, according to a large registry study reported in the Journal of the American Medical Association for June 2.

The combination was particularly effective in high risk patients – who unfortunately were the group least likely to be treated with it, the research team said.

Dr. Steven P. Marso, from the University of Missouri Kansas City, told Reuters Health that he recommends the combined strategy for patients at high risk of bleeding who have no contraindications to either treatment. In these patients, using both treatments lowered the absolute rate of PCI-related bleeding by 3.8%.

Dr. Marso’s team studied more than 1.5 million patients from the National Cardiovascular Data Registry CathPCI Registry. Two percent developed periprocedural bleeding associated with either a blood transfusion, a prolonged hospital stay, or a drop in hemoglobin level of 3 g/dL or more.

Clinicians used vascular closure devices in 24% of cases of bleeding, bivalirudin in 23%, and both strategies in 18%. They used manual compression (the reference strategy) in 35%.

Overall, bleeding developed in 2.8% of patients after manual compression, 2.1% treated with vascular closure devices, 1.6% receiving bivalirudin, and 0.9% receiving both strategies (p 3%), doctors should strongly consider bivalirudin plus vascular closure devices, unless there are extenuating circumstances, because bleeds are expensive, morbid, and mortal, and the treatments are highly effective.”

He noted that to prevent 1 bleeding event in high risk patients would require treating 33 patients with both therapies.

For those at intermediate risk (1%-3%), he advises using just one of the strategies. And for those with lower risk, “physicians should consider not using either one, since bivalirudin costs $600 or $700, the devices are $150-$250… I’m not sure there’s a real benefit with respect to bleeding mitigation in the low-risk group.”

Bivalirudin is not recommended in patients treated with anticoagulants, and it also should be avoided in patients undergoing PCI for a chronic total occlusion or in those with renal failure. Vascular closure devices shouldn’t be used if there are anatomical limitations, including puncture at the site of an anatomic arterial bifurcation, severe calcification, or severe obstructive peripheral artery disease.

In an editorial, Dr. Deepak L. Bhatt at VA Boston Healthcare System says this study nicely illustrates “the immense value that real-world data can provide to enhance the care of patients with cardiac disease.”

Reference:

JAMA 2010;303:2156-2164,2188-2189.