1. Patterns of red blood cell transfusion use and outcomes in patients undergoing percutaneous coronary intervention in contemporary clinical practice: Insights from the NCDR ® Matthew W. Sherwood, Yongfei Wang, Jeptha P. Curtis, Eric D. Peterson, Sunil V. Rao

2. Disclosures Matthew W. Sherwood – None Yongfei Wang – None Jeptha P. Curtis – None Eric D. Peterson – Research Support >10K : Eli Lilly, Janssen Pharm., PI of Data Analytic Center for ACC Sunil V. Rao – Research grants - Ikaria, sanofi-aventis; Consultant/honoraria - The Medicines Co, Terumo Medical, ZOLL, Astra Zeneca, Daiichi Sankyo Lilly, Janssen

3. Funding Support and Disclaimer This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR). The views expressed in this presentation represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at www.ncdr.com. www.ncdr.com

4. Background Prior studies have shown that there is marked variation in the use of red blood cell transfusion (RBCT) among patients with acute coronary syndromes Contemporary post-procedure RBCT patterns in patients undergoing PCI are unclear Documenting variation in RBCT practice is important since RBCT has been independently associated with morbidity and mortality in patients with ischemic heart disease

5. Objectives To determine the variability in use of RBCT in hospitals across the United States To determine patient factors associated with RBCT To determine whether RBCT has an independent association with patient outcomes – Is an association of transfusion with outcomes independent of bleeding

6. Methods Database – NCDR ® Cath-PCI ® database Patients – 1,323,965 patients undergoing PCI at 1282 hospitals between 7/2009-9/2011 Exclusions – patients who underwent in-hospital CABG – More then 1 PCI during hospital stay – Missing data on bleeding events, procedural complications, d/c status

7. Outcomes and Definitions Primary – Transfusion rates Secondary – Clinical Outcomes – MI – Stroke – In-hospital Death Definition – Bleeding Events – Hemoglobin drop of ≥3 g/dL – Transfusion of whole blood or packed red blood cells – Procedural intervention/surgery at the bleeding site to reverse/stop or correct the bleeding

8. Analyses Rates of transfusion by site were determined and then risk adjusted rates were calculated Patient clinical characteristics and in-hospital outcomes were compared between patients who did and did not receive RBCT Logistic regression was used to determine the adjusted association between RBCT and in-hospital death, MI, or stroke – Secondary analyses performed to determine whether any adverse effect of transfusion was independent of bleeding events

9. Patient Characteristics (%) Without RBCT N=1294710 With RBCT N=29255 Age (mean, SD)64.5 (12.1)70.5 (12.1) Gender (% Female)32.257.4 HTN81.886.2 Diabetes34.144.3 ESRD on dialysis2.27.8 Prior MI29.932.4 Prior CHF11.426.0 P values for all comparisons <0.001

10. Transfusion Pattern by Hgb

11. Transfusion Rates by hospital site

12. Adjusted transfusion rates Number of hospitals Risk adjusted for all variables in the established NCDR mortality and bleeding models

13. Outcomes by transfusion status Patient Outcomes (%) Without RBCT N=1294710 With RBCT N=29255 MI1.94.8 Stroke0.21.9 CHF0.79.6 Cardiogenic Shock0.79.9 In-hospital Death1.111.9 Bleeding Events0.936.2 Access Site bleeding0.512.3 Non-Access Site bleeding0.423.9 P values for all comparisons <0.001

14. Independent assoc. of RBCT with outcomes Patient OutcomesOdds Ratios MI, Stroke, In-hospital Death 2.18 (2.09-2.26) MI1.96 (1.85-2.08) Stroke3.92 (3.53-4.35) In-hospital Death2.02 (1.92-2.13) Model includes all variable in the established NCDR mortality model; Reference is no transfusion All patients

15. Patient OutcomesOdds Ratios MI, Stroke, In-hospital Death 1.95 (1.86-2.05) MI1.71 (1.58-1.85) Stroke4.07 (3.60-4.60) In-hospital Death1.73 (1.62-1.84) Model includes all variable in the established NCDR mortality model; Reference is no transfusion Independent assoc. of RBCT with outcomes Patients without bleeding

16. Limitations Data is observational thus events are reported, not adjudicated Temporal relationship between Hct, transfusion, and events is uncertain Cannot infer causality

17. Conclusions Considerable variation in transfusion practices exists across the U.S., and persists after adjustment for patient differences Transfusion patterns by Hgb level are different in patient with bleeding vs. without bleeding RBCT is independently associated with adverse cardiac events in patients undergoing PCI – This association still holds in patients without bleeding events

18. Clinical Implications Our results are consistent with prior reports demonstrating the potential hazard associated with RBCT among ACS patients Randomized trials of transfusion strategies are needed in patients undergoing PCI to guide clinical practice Until these data are available, operators should continue to adopt practices that reduce the risk for bleeding and transfusion