Strategies to Limit Bleeding in PCI Underused

Strategies to limit periprocedural bleeding in percutaneous coronary interventions are effective, particularly in the patients at highest risk for bleeding, according to a study of a nationwide database.

Unfortunately, these strategies are underused, and the very patients most likely to benefit are the least likely to receive them, reported Dr. Steven P. Marso of Saint Luke's Mid America Heart Institute, Kansas City, Mo., and his associates.

Targeting bleeding complications “holds great potential for improving the safety and cost-effectiveness of PCI,” since more than 1 million of the procedures are performed in the United States every year and bleeding complications occur in 2%-6% of them. Major bleeding events raise the risks for early and late mortality, MI, and stroke, and also “result in an average 4- to 6-day increase in length of stay and, on average, increase hospital costs by $6,000-$8,000,” the investigators noted.

They studied bleeding complications using the National Cardiovascular Data Registry, a nationwide database of catheterization and PCI procedures at more than 1,100 medical centers. They assessed data on more than 1.5 million patients who underwent PCI via the femoral artery approach during the period from Jan. 1, 2004, to Sept. 30, 2008.

To mitigate bleeding, vascular closure devices such as Angio-Seal (St. Jude Medical) and Perclose A-T (Abbott Vascular), the drug bivalirudin (Angiomax), or both were used in 24%, 23% and 18% of patients, respectively. Manual compression, used in 35% of patients, served as the control strategy.

Periprocedural bleeding, the primary outcome for this study, occurred in more than 30,000 patients (2%). This was defined as bleeding that required a blood transfusion or a prolonged hospital stay, or bleeding that was associated with a greater than 3-g/dL decline in hemoglobin level.

Bleeding events occurred in 2.1% of patients in whom vascular closure devices were used, 1.6% who received bivalirudin, and 0.9% who received both preventive strategies. In comparison, bleeding events occurred in 2.8% of patients who received manual compression.

Independently of preprocedural risk of bleeding, vascular closure devices were associated with 6.7 fewer bleeding events per 1,000 patients, bivalirudin was associated with 8.5 fewer events per 1,000, and the combination of both devices and bivalirudin was associated with 14.2 fewer events, compared with manual compression.

In a further analysis of the data, patients were stratified according to their estimated risk for bleeding before the procedure began. As bleeding risk increased, differences in actual bleeding rates between the four strategies became more pronounced.

Among the highest-risk patients, “the use of vascular closure devices plus bivalirudin was associated with an absolute 3.8% lower bleeding rate, which translates into an estimated number needed to treat of 33 to prevent 1 bleeding event, as compared with manual compression,” Dr. Marso and his colleagues wrote (JAMA 2010;303:2156-64).

A total of 40.3% of patients at highest risk received manual compression, compared with 30.8% of those with the lowest risk. However, 14.4% of the highest-risk patients received bivalirudin plus vascular closure, compared with 21.0% of the lowest-risk patients.

Translating these study findings into change in clinical practice will be “challenging” for several reasons, the researchers noted.

“First, assessing the risk for bleeding in clinical practice is neither inherently intuitive nor commonly used. Second, physicians have more experience using bivalirudin in lower-risk patients, since it was first studied in patients undergoing elective PCI and only recently in higher-risk patients,” they said.

In addition, some patients are not suited to one or the other of these strategies. Bivalirudin is not recommended in those taking anticoagulants or those who have a chronic total occlusion, and closure devices are not recommended in patients with certain anatomical limitations such as severe calcification or peripheral artery disease.

Disclosures: Dr. Marso and his associates reported receiving support from many sources, including The Medicines Company (maker of bivalirudin), Amylin Pharmaceuticals, Boston Scientific, Volcano Corp., Terumo Corp., Abbott Vascular, and NovoNordisk.