Risk Stratification Before PCI Ups Use of Bleeding Avoidance Strategies in High-Risk Patients

Estimating the bleeding risk of each patient before PCI is feasible and leads to greater use of bleeding avoidance strategies, according to a study published online March 24, 2015, ahead of print in the BMJ. Even with individualized risk assessment, use of the strategies varied widely both among and within hospitals.Take Home: Risk Stratification Before PCI Ups Use of Bleeding Avoidance Strategies in High-Risk Patients

“Decreasing such variability in care based on physicians’ preferences, rather than patients’ benefits, represents an important opportunity to improve quality and outcomes,” write John A. Spertus, MD, MPH, of St. Luke’s Mid America Heart Institute (Kansas City, MO), and colleagues.

For the study, a tool called ePRISM (Health Outcomes Sciences, Overland Park, KS) was used to integrate personalized bleeding risk assessment into the informed consent document at 9 US hospitals for all patients undergoing nonemergent coronary angiography and possible PCI (n = 3,529).

This cohort was compared with patients treated at the same hospitals in the prior 12 months (n = 7,408). Baseline characteristics were similar for patients before and after adoption of bleeding risk stratification. Data from the National Cardiovascular Data Registry (NCDR) CathPCI Registry from the same 2 time periods were used to adjust for contemporary trends.

The 3 bleeding avoidance strategies studied were bivalirudin, vascular closure devices, and radial access.

Risk Assessment Drives Change

Over an observation period of 9.4 ± 2.3 months, use of bleeding avoidance strategies rose after personalized assessment was added to consent forms (OR 1.81; 95% CI 1.44-2.27), with the greatest increase seen in those at high risk (OR 2.03 vs 1.48 for low risk; P = .05 for interaction). Although use of bivalirudin remained about the same overall, there was more emphasis on its use in patients at moderate/high bleeding risk than those at low risk (table 1).

 Table 1. Processes of Care: Before vs After Implementation

Rates of periprocedural bleeding were lower across risk categories with personalized assessment. However, there were no differences in in-hospital mortality (table 2).

  Table 2. Clinical Outcomes: Before vs After Implementation

Compared with control hospitals from the NCDR, hospitals that implemented risk assessment were less likely to use bivalirudin in low-risk patients (P = .04) but just as likely to give it to moderate-/high-risk patients. The decreased risk of periprocedural bleeding seen at participating hospitals was also apparent when compared with the NCDR controls (P = .006).

There was no change in use of vascular closure devices before vs after adoption of the assessment tool nor difference in use between study and control hospitals. Radial access use increased similarly between study and control hospitals.

After adoption of ePRISM, hospitals still varied widely in their use of bleeding avoidance strategies, both overall and for the individual methods:

  • Any strategy: 31%-98%
  • Bivalirudin: 1%-96%
  • Vascular closure devices: 3%-70%
  • Radial access: 1%-51%

In addition, between 2 randomly selected physicians at the same hospital treating similar patients, there was a 4-fold difference in their likelihood to use an avoidance strategy. Bivalirudin was the most variable, with some physicians never using it and others using it in all high-risk patients.

Incentives Needed to Inspire Change

In an email with TCTMD, Sunil V. Rao, MD, of Duke University Medical Center (Durham, NC), said that while some degree of variation among hospitals and operators is expected and probably good, “when known beneficial treatments are not used in patients who are most likely to benefit, there is a problem.”

But changing the behaviors of physicians and providers is not easy, he observed. “This study shows that simply presenting them with a patient’s risk can result in improvements,” Dr. Rao said. “But we need more efforts. In the United Kingdom, a private insurer (Bupa) now pays £350 more to an interventional cardiologist if the PCI is done radially. Maybe we need to think about that kind of strategy where better practice is more tightly linked to [relative value units], physician payment, etc.”

According to Dr. Rao, it is relatively straightforward to incorporate bleeding risk stratification into clinical practice using currently available software options such as ePRISM.

Ultimately, this study is a first step toward “precision medicine,” he commented.

“We tend to think of that term as referring to complex genetically based treatments, but we should realize that we can make a huge impact just by better implementing existing treatments and eliminating the ‘risk-treatment paradox,’” Dr. Rao noted, referring to the scenario in which the high-risk patients most likely to derive benefit from a therapy are least likely to receive it.

A Push for More Bleeding Avoidance

Gjin Ndrepepa, MD, and Adnan Kastrati, MD, both of the German Heart Centre (Munich, Germany), note in an accompanying editorial that bleeding avoidance strategies “are likely to be cost-effective in many healthcare settings owing to the substantial costs of periprocedural bleeding, particularly if use is tailored to each patient’s baseline risk.”

This approach “has the potential to reduce bleeding events, prevent suffering, and improve quality of life for patients undergoing PCI,” they add. “The cardiology community should strive to ensure that the individualized implementation of these strategies becomes a central component of our practice in the coming years.”

However, Drs. Ndrepepa and Kastrati point to certain limitations of the current study, including its nonrandomized design and lack of independent adjudication of bleeding events. Importantly, they also note that the bleeding reduction’s failure to budge in-hospital mortality “seems counterintuitive, given the strong association between bleeding and mortality.”

 


Sources:
1. Spertus JA, Decker C, Gialde E, et al. Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks. BMJ. 2015;Epub ahead of print.
2. Ndrepepa G, Kastrati A. Minimising bleeding during percutaneous coronary intervention: identify high risk patients likely to benefit from bleeding avoidance strategies [editorial]. BMJ. 2015;Epub ahead of print.

Disclosures:

  • The study was funded by grants from the American Heart Association and the National Heart, Lung, and Blood Institute.
  • Dr. Spertus reports owning several patents on the ePRISM technology and having an economic interest in Health Outcomes Sciences.
  • Drs. Ndrepepa, Kastrati, and Rao report no relevant conflicts of interest. 

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