NCDR PVI Registry Studies Bleeding Risk With Interventions for Lower Extremity PAD

June 28, 2019—The American College of Cardiology (ACC) announced the publication of a study showing that major bleeding occurred in approximately 4% of peripheral vascular interventions (PVIs) to treat lower extremity peripheral artery disease (PAD) and led to an increased risk of in-hospital deaths. Investigators identified several risk factors that increase the chance of bleeding, which can help guide future efforts to reduce bleeding complications.

The study was published by Bhaskar Bhardwaj, MD, et al online in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions. This is the first published research using the National Cardiovascular Data Registry (NCDR) PVI registry data, according to the ACC.

Adam C. Salisbury, MD, the study's lead investigator, commented in the ACC press release, “This is the first large-scale study to describe the frequency of bleeding in patients undergoing lower extremity PVI. Bleeding has been well studied in coronary artery procedures but not in vascular procedures involving the lower extremities.”

As summarized in the ACC announcement, the investigation included patients undergoing PVI at 76 hospitals in the NCDR PVI registry from 2014 to 2016. Among 18,289 PVI procedures, major bleeding occurred in 744 (4.1%). The in-hospital death rate was higher in patients who experienced bleeding compared with those who did not (6.6% vs 0.3%).

The investigators reported that patient characteristics associated with bleeding included age, female sex, heart failure, and anemia. Patients with resting leg pain or ulcerations caused by poor blood flow were also at higher risk.

Additionally, the investigators found that certain procedural strategies were associated with bleeding, such as catheter access through arteries other than through the femoral artery. The use of thrombolytic therapy was also associated with an increased risk of bleeding.

Dr. Salisbury concluded, “The findings suggest we can use different procedural strategies, such as using different access points for the catheter, alternative blood thinners, or different sizes of equipment, to reduce the risk of bleeding. We can use the findings to identify factors and create models to predict who is at higher risk of bleeding. In these patients, we need to be especially careful to avoid doing anything that could increase the risk of bleeding.”

In an editorial comment accompanying the study in JACC: Cardiovascular Interventions, Douglas E. Drachman, MD, and Beau M. Hawkins, MD, stated that the study “demonstrates that bleeding is a common complication of PVI, and that bleeding confers significant clinical risk. For clinicians engaged in the care of patients with lower extremity PAD, this represents an opportunity to establish best practices and improve patient outcomes: it is time to stop the bleeding.”