A Closer Look at Bleeding Avoidance Strategies in PCI Reveals Little Impact on Outcomes
Hospitals substantially vary in their proclivity to use bleeding avoidance strategies—radial access, bivalirudin, and vascular closure devices—in PCI patients, according to new registry data, but use of these tactics only accounts for about 8% of the hospital-level variation in bleeding.
As bleeding outcomes have become more important for measuring hospital PCI quality, contemporary studies have focused on the risks and benefits associated with radial compared with femoral access, bivalirudin compared with heparin plus glycoprotein IIb/IIIa inhibitors, and the use of vascular closure devices versus manual compression in transfemorally treated patients. In the years that cardiologists have debated each of these comparisons, no definitive randomized data have confirmed the superiority of any of these strategies, yet both sides have ardent supporters.
Researchers led by Amit N. Vora, MD (Duke University Medical Center, Durham, NC), looked at use of bleeding avoidance strategies in almost 2.5 million PCI procedures at 1,358 US sites participating in the NCDR CathPCI registry from July 2009 to June 2013. Overall 5.1% of patients had a bleeding complication, with these patients being less likely to have received transradial access, bivalirudin, or vascular closure devices than those who did not bleed (P < 0.001 for all).
Additionally, they found that although the median bleeding rate among all hospitals was 5.0%, it ranged substantially from 2.7% to 6.6%, and this variation remained after adjustment for patient risk factors. Because of this, the researchers deduced that patient risk factors accounted for up to 20% of the overall hospital-level variation in bleeding rates, with use of bleeding avoidance strategies making up almost 8%—1.26% for radial access, 5.85% for bivalirudin, and 0.88% for vascular closure devices. This left “more than 70% of the variation in bleeding . . . unexplained,” they write.
A median of 86.6% of hospitals used any of the bleeding avoidance strategies over the study period, with patients treated at lower-volume hospitals more apt to receive them. Patients treated at hospitals in the lowest tertile of bleeding avoidance strategy use were more likely to be women and have a history of MI, heart failure, stroke, peripheral vascular disease, diabetes, and renal failure.
Bleeding as a Performance Measure?
The variations among hospitals in bleeding avoidance strategy use and their minimal association with bleeding outcomes leads the authors to question the validity of even using bleeding as a performance measure at all “under the current data collection structure,” they write. Other measures of quality, like appropriate use criteria, might be better applied when comparing hospital outcomes and performance, Vora and colleagues suggest.
“However, none of these metrics should be used for determining reimbursement until they have been appropriately vetted as performance measures,” they add.
The results also highlight the need for registries to “collect more granular data on procedural factors and bleeding events” so that researchers can create more realistic risk-adjustment models that accurately account for hospital variability, the researchers write. Information on anticoagulant and antiplatelet prescriptions, sheath management, and interoperator variability in femoral access, would all be helpful to know, they add.
While the authors make a valid argument with regard to reimbursement, writes Eric Bates, MD (University of Michigan Medical Center, Ann Arbor), in an accompanying editorial, the authors neglect to discuss the surprising lack of a substantial reduction bleeding with transradial access. Without solid data to back them up, he argues, the benefits of a radial approach—as well as of bivalirudin and vascular closure devices—may develop legendary potential, hyped so much that they are widely accepted as truth.
“US interventionalists have been criticized for being slow to adopt radial artery access. And yet, the radialists need to avoid hubris and prove to the skeptics that they are not wearing the emperor’s new clothes when they promote the superiority of radial artery access over femoral artery access for all patients,” Bates writes.
Only a randomized trial with “appropriate endpoints that proves a causal relationship between vascular access site complications and mortality” will solve the radial versus femoral debate once and for all, he says, adding that radial access seems to have no impact on MI, stroke, TVR, or stent thrombosis. Outcomes after a transradial procedure are also dependent on hospital and operator radial volume as well as patient variables, Bates explains.
The fact that vascular closure devices were not associated with a large reduction in bleeding rates was “predictable,” he says, adding that it is unclear why they even remain a bleeding avoidance strategy. Similarly with bivalirudin, “it could be argued that it was the avoidance of glycoprotein IIb/IIIa inhibitors, rather than the use of bivalirudin, that made the difference,” Bates writes.
- Arterial Closure in Transfemoral PCI May Offer Clinical Benefit, but Cost-Effectiveness Unclear
- Choosing Radial Over Femoral: Single-Center Study Tackles Questions of When and Why
- Risk Stratification Before PCI Ups Use of Bleeding Avoidance Strategies in High-Risk Patients
Vora AN, Peterson ED, McCoy LA, et al. The impact of bleeding avoidance strategies on hospital-level variation in bleeding rates following percutaneous coronary intervention: insights from the National Cardiovascular Data Registry CathPCI registry. J Am Coll Cardiol Intv. 2016;9:771-779.
Bates ER. Bleeding avoidance strategies, performance measures, and the emperor’s new clothes. J Am Coll Cardiol Intv. 2016;9:780-783.
- Vora and Bates report no relevant conflicts of interest.