Elsevier

American Heart Journal

Volume 243, January 2022, Pages 221-231
American Heart Journal

Clinical Investigations
The bleeding risk treatment paradox at the physician and hospital level: Implications for reducing bleeding in patients undergoing percutaneous coronary intervention

https://doi.org/10.1016/j.ahj.2021.08.021Get rights and content

Background

Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: “bleeding risk-treatment paradox” (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients’ bleeding risk (ie, exhibit a RTP) have higher bleeding rates.

Methods

We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients’ predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding.

Results

Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 – a period more reflective of the contemporary practice.

Conclusions

Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding.

Section snippets

Methods

No extramural funding was used to support this work. The authors are solely responsible for the design and conduct of this study, all study analyses, and the drafting and edition of the paper and its final contents.

Study sample

Data for this study of 28,005 PCIs came from 26,784 patients, of whom 25,589 (95.5%) underwent 1 PCI, 1,169 (4.4%) 2 PCIs and 26 (0.1%) 3 PCIs during the study period. The average age of the patients was 65.6 years. Obesity (body mass index >30 kg/m2, 46.6%), diabetes mellitus (40.4%), dyslipidemia (84.5%), and hypertension (83.8%) were the common comorbidities. There was also a high proportion of chronic renal (26.4%) and lung (17.6%) disease. The average left ventricular ejection fraction was

Discussion

This is the first study to examine the variation of RTP among physicians and hospitals, as well as its correlation with bleeding outcomes. Hospitals and physicians with higher rates of RTP were strongly and independently associated with worse bleeding (Figure 2A and B; P-value <.0001). Consistent with prior studies of individual risk,2, 3 patients with RTP were more likely to have a bleeding complication (OR 1.66), independent of their bleeding and mortality risks. There was significant

Conclusion

Bleeding RTP is a strong and independent predictor of bleeding at both the hospital- and physician-level. It exists at the level of physicians and hospitals: hospitals and physicians with a higher rate of RTP were strongly and independently associated with worse bleeding rates. As the United States’ healthcare system increasingly focuses on quality improvement and consistency in care delivery, distribution and widespread implementation of best practices will be key. These findings underscore

Author Disclosures

Dr Amit P. Amin – has received a comparative effectiveness research KM1 career development award from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences of the National Institutes of Health, Grant Numbers UL1TR000448, KL2TR000450, TL1TR000449 and the National Cancer Institute of the National Institutes of Health, Grant Number 1KM1CA156708-01; an AHRQ R18 grant award (Grant Number R18HS0224181-01A1), has received an

Funding Sources

Unrestricted grant from Terumo Corporation Inc.

Role of any Sponsor

No sponsor participated in the design and conduct of the study, collection, analysis, or interpretation of the data, nor in the preparation, review, nor approval of the manuscript.

Data Access and Responsibility

Drs Amin and Kulkarni had full access to the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

References (29)

  • WJ Dewilde et al.

    Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial

    Lancet

    (2013)
  • C Decker et al.

    Understanding physician-level barriers to the use of individualized risk estimates in percutaneous coronary intervention

    Am Heart J

    (2016)
  • SP Marso et al.

    Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing Percutaneous Coronary Intervention

    JAMA

    (2010)
  • Amit P Amin et al.

    Reversing the “Risk-Treatment Paradox” of bleeding in patients undergoing Percutaneous Coronary Intervention: risk-concordant use of bleeding avoidance strategies is associated with reduced bleeding and lower costs

    J Am Heart Assoc

    (2018)
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    This paper was handled by Guest Editor (David R. Holmes, MD, Clin. Inv.)

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    Equal contribution as first author.

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