Substantial Segment of Variations in Post-PCI Bleeding Are Unexplained
Variations in post-percutaneous coronary intervention (PCI) bleeding rates should not necessarily be used as a performance measure because a significant portion of these variations are unexplained, asserts a study published April 18 in JACC: Cardiovascular Interventions.
Using data from ACC’s CathPCI Registry, researchers examined records from almost 2.5 million procedures at 1,358 sites between 2009 and 2013 to determine whether combinations of bleeding avoidance strategies – use of the radial artery for access during PCI, administering the blood thinner bivalirudin, and sealing off the point of access with a vascular closure device – had an impact on bleeding totals.
Throughout the study period, 125,361 bleeding events were observed. Overall, there was significant variation in bleeding rates among hospitals, ranging from 2.6 percent to 9.3 percent. Approximately 70 percent of this variation could not be attributed to any specific cause, while patient factors were identified as the cause for 20 percent and use of radial access and bivalirudin was attributed to 7.8 percent.
Consistent with previous research, the study also demonstrated the risk-treatment paradox—when patients who need an intervention the most receive it the least frequently. Data showed that patients receiving bleeding avoidance strategies had a predicted bleeding risk of 3.2 percent, compared with a predicted bleeding risk of 4.5 percent among those not receiving these strategies. Patients who had the procedure done with radial access had less bleeding than those who did not (5 percent vs. 11.2 percent). Bivalirudin therapy was used less frequently among patients who experienced bleeding (43.8 percent vs. 59.4 percent) and vascular closure devices were used at lower rates (32.9 percent vs. 42.4 percent).
The study “underscores the need for consistent application of appropriate bleeding avoidance strategies (BAS) in all patients,” said lead author Amit N. Vora, MD, MPH, “especially those at particularly high risk for bleeding complications following PCI.” Vora noted that when hospitals used bleeding avoidance strategies in more than 85 percent of patients, bleeding rates were lower. Given these results, Vora suggested that broadening the use of these strategies in all patients can not only overcome the risk-treatment paradox but may also be a way to reduce variation in hospital bleeding rates.
Researchers recommended “further analyses to determine the causes of variation in bleeding following PCI among hospitals, including the use of vascular ultrasound during the procedure when using the femoral artery as the access point, along with using protocols to stop bleeding.” Additionally, improved data collection could help explain bleeding variations across sites and circulate best practices from high-performing centers.
Keywords: Anticoagulants, Femoral Artery, Hirudins, Peptide Fragments, Percutaneous Coronary Intervention, Radial Artery, Registries, Vascular Closure Devices, CathPCI Registry, National Cardiovascular Data Registries
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