JAMA: Vascular closure device+bivalirudin stops bleeding, not used uniformly

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For patients undergoing PCI, use of vascular closure devices and bivalirudin  to stop periprocedural bleeding may lower the risk but this strategy is less likely to be used on high risk patients who would most benefit from the technique, according to a study published in the June 2 edition of the Journal of the American Medical Association.

Each year, one million PCI procedures are performed and of those, bleeding complications occur at a rate of 2 to 6 percent. According to the authors, experiencing a major bleeding complication results in a four- to six-day increase in length of stay and on average increases hospital costs by $6,000-$8,000.

Steven P. Marso, MD, of Saint Luke’s Mid America Heart Institute in Kansas City, Mo., and colleagues assessed the National Cardiovascular Data Registry (NCDR) to evaluate the preprocedural bleeding risk and its patterns after PCI.

The researchers identified 1,759,408 patients from 955 U.S. hospitals who underwent PCI—1,522,935 patients were eligible to participate in the study.

During the study, the researchers placed patients in four groups: 529,246 patients received manual compression; 363,583 patients received a vascular closure device (Angio-Seal, St. Jude Medical or Perclose A-T, Abbott Vascular); 353,769 patients were administered bivalirudin (Angiomax, The Medicines Company), and 276,336 patients received both a vascular closure device and bivalirudin.

Results showed that bleeding occurred in 30,429 patients (2 percent). Additionally, bleeding events occurred in 2.8 percent of patients who received manual compression, 2.1 percent in patients with vascular closure devices, 1.6 percent who received bivalirudin and 0.9 percent in patients who received both bivalirudin and vascular closure devices.

Marso et al also placed patients into three categories: low risk, intermediate risk and high risk.

The researchers found that manual compression was used more often in patients considered high risk compared to those who were considered low risk, 40.3 percent versus 30.8 percent, respectively.

In contrast, use of vascular closure devices and bivalirudin took place most often in patients who were low risk (21 percent) compared to those who were at intermediate risk (17.8 percent) or high risk (14.4 percent).

Additionally, bleeding rates for patients in the low-risk, intermediate-risk and high-risk groups who underwent manual compression were 0.9 percent, 2.3 percent and 6.1 percent.

These rates for vascular closure devices were 0.9, 1.9, and 3.8 percent, respectively, while bleeding rates for vascular closure plus bivalirudin were 0.4, 1.4 and 2.3 percent, respectively.

The results showed a 3.8 percent lower absolute bleeding rate for high-risk patients who were in the bivalirudin and vascular closure arm compared to those within the other cohorts.

“Despite the association between the use of vascular closure devices plus bivalirudin and lower bleeding rates among the highest risk patients, these patients were the least likely to receive both strategies and most likely to receive manual compression.”

According to the authors, several reasons may pertain to why these bleeding avoidance strategies are used at a greater capacity in lower risk patients. The first is that “assessing the risk for bleeding in clinical practice is neither inherently intuitive nor commonly used,” the authors wrote.

Secondly, bivalirudin use in lower risk patients has been previously studied and physicians have more experience administering the drug to these patients. Additionally, the authors said that clinical trial and research regarding vascular closure devices and their safety and efficacy are scarce.

Marso et al said that targeting bleeding complications can improve the safety of PCI and also provide a cost savings.

“The results of this study suggest the need for additional research to better understand why higher-risk patients are least likely to receive bleeding avoidance strategies but also suggest the need to test interventions to overcome the risk-treatment paradox, such as enabling physicians to purposely direct bleeding avoidance strategies to patients by providing preprocedural estimates of post-PCI bleeding,” the authors wrote.

The authors said that incorporating risk models into clinical care and implementing quality-of-care tools could add to improved and effective care.

“These findings emphasize the opportunity to improve the safety of PCI and to further explore cost efficacy