TCT Bajaj

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TCT Bajaj

  1. 1. Impact of anti-thrombin therapy on hospital cost and length of stay in adult patients undergoing angioplastyRetrospective analysis of the Premier Perspective Database<br />Neeraj R. Bajaj 1, Weihong Fan 2, Howard A. Cohen 1 , Kirk N. Garratt 1<br />1. Lenox Hill Hospital<br />2. The Medicines Company<br />
  2. 2. Disclaimer<br /><ul><li>Neeraj R. Bajaj has no conflicts to disclose.
  3. 3. Weihong Fan receives salary support from The Medicines Company.
  4. 4. Howard A. Cohen has no conflicts to disclose.
  5. 5. Kirk N. Garratt receives consulting service fees and speaker’s bureau honoraria from the Medicines Company.</li></li></ul><li>Research Objectives<br /><ul><li> The ability of bivalirudin (BIV) to reduce bleeding events while preserving low ischemic event rates during percutaneous coronary intervention (PCI) has been well documented across the spectrum of stable and acute coronary syndrome patients in randomized controlled trials. 1,2,3 Economic analyses from these trial data found BIV monotherapy was associated with reduced hospital costs. 4
  6. 6. The economic impact of BIV or unfractionated heparin/enoxaparin (HEP) use during PCI, with or without glycoprotein IIb/IIIa inhibitor (GPI), in unselected patients, is less certain.
  7. 7. The purpose of this study is to evaluate the impact of anti-thrombin choice on length of hospital stay after PCI (LOS) and cost in a large unselected population.</li></li></ul><li>Premier Perspective Database<br /><ul><li> We evaluated the Premier Perspective Database, one of the largest US hospital administrative databases providing detailed clinical and economic information from more than 600 hospitals annually.  Service-level information is available from over 45 million hospital records and 210 million hospital visits.
  8. 8. The database contains standard data elements available in hospital discharge files.   Diagnoses and procedures are categorized according to the International Classification of Diseases, Ninth Revision (ICD-9), and Current Procedural Terminology (CPT) codes.
  9. 9. Data routinely undergo quality and completeness checks (data verification, reconciliation, and validation) as well as checks on clinical resource consumptions, manual data audit, and a warehouse audit. 5
  10. 10. Data for this analysis were extracted from Q1/2004 to Q1/2008. After exclusion criteria were applied, 452,044 PCI admissions were reviewed representing 299 teaching, non-teaching, urban and rural hospitals of varying size.</li></li></ul><li>PCI admissions between the 1st quarter of 2004 and the 1st quarter of 2008<br />N=640,110<br />PCI admissions with invalid or unknown PCI service day, N=4,722 (0.74%)<br />PCI admissions with valid PCI service day <br />N=635,388<br />Patients who are < 18 yrs old or with unknown gender, N=128 (0.02%)<br />Patients who are ≥ 18 yrs old with known gender <br /> N=635,260<br />Patients without a record of treatment ofeither BIV ± GPI or HEP ± GPI, N=142,959 (22.5%)<br />Patients treated with BIV ± GPI or HEP ± GPI on the PCI procedure day<br />N=492,301<br />Patients who had an outpatient procedure, <br />N=31,023 (6.30%)<br />Patients who had an inpatient procedure<br />N=461,278<br />Patients with a diagnosis for subsequent or unknown episode of care for AMI, N=884 (0.19%)<br />Patients diagnosed with AMI (initial episode of care), UA, SA, other forms of CIHD, or other diagnosis <br />N=460,394<br />Patients with length of stay > 90 days or cost ≤ $0, or > $1,000,000, N=1,946 (0.42%)<br />Patients with length of stay ≤ 90 days and cost > $0 or ≤ $1,000,000<br />N=458,448<br />Patients with CABG during hospitalization<br />N=6,404 (1.40%)<br />Study Population<br />PCI Inpatients Population Without CABG during hospitalization<br />N=452,044<br />SA= stable angina<br />CIHD= chronic ischemic heart disease<br />
  11. 11. Methods<br /><ul><li> Patients were stratified according to anti-coagulant status on the day of PCI procedure and were divided into four groups: BIV, BIV+GPI, HEP, and HEP+GPI.
  12. 12. Treatment decisions were based on physician preference and individual hospital standards of care and policy. Multivariate analysis (MVA) was used to adjust for confounding patient and hospital covariates and bleeding complications.
  13. 13. Linear regression models of LOS, actual cost of hospitalization, and natural log transform of cost were developed. Covariates included: patient demographics, admission year, diagnosis (STEMI, non-STEMI, unstable angina, stable angina, chronic ischemic heart disease(CIHD)), insurance payor, hospital characteristics (region, rural/urban, teaching status, and bed size), patient co-morbidities, concomitant medication use, procedural information, and bleeding complications.
  14. 14. Sensitivity analyses were conducted to assess the robustness of MVA results by including or excluding bleeding patients.</li></li></ul><li>Results <br />Note: All comparisons are 4-way. All P-values are <0.0001<br />
  15. 15. Results<br />Note: All comparisons are 4-way. All P-values are <0.0001<br />
  16. 16. Results<br />Note: All comparisons are 4-way. All P-values are <0.0001<br />
  17. 17. Results <br />Note: All comparisons are 4-way. All P-values are <0.0001<br />
  18. 18. Results<br />Note: All comparisons are 4-way. All P-values are <0.0001<br />
  19. 19. Results <br />
  20. 20. Results<br />Note: This analysis was conducted based on N = 425,145 non-bleeding patients.<br />
  21. 21. Results<br />Note: This analysis was based on N = 26,899 bleeding patients. Due to the smaller number of patients, the MVA of natural log transformation of cost is presented only.<br />
  22. 22. Conclusions<br /><ul><li>In this large observational sample of unselected patients presenting with a variety of clinical cardiac syndromes, 34.3% received BIV, 7.3% BIV+GPI, 18.6% HEP, and 39.8% HEP+GPI. The mean of length of stay post-PCI was 1.3 days and the mean of cost was $15641.
  23. 23. Univariate analysis indicated BIV monotherapy was associated with lower costs and shorter LOS after PCI.
  24. 24. After adjustment for covariates, BIV monotherapy was associated with significantly lower costs ($1116 less) and shorter LOS after PCI (0.276 days less) when compared with HEP+GPI.
  25. 25. The advantages of BIV monotherapy were observed in patients with and without bleeding complications.</li></li></ul><li>Study Limitations<br /><ul><li>Non-randomized study.
  26. 26. Inherent limitations of registry data and data collection.
  27. 27. Exclusion of significant number of PCI patients (22.5%) without a record of treatment of either bivalirudin ± GPI or heparins ± GPI.
  28. 28. Possibility of unmeasured confounders affecting multivariate analysis.</li></li></ul><li>References<br />Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003 Feb 19;289(7):853-63.<br />Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006 Nov 23;355(21):2203-16.<br />Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008 May 22;358(21):2218-30.<br />Cohen DJ, Lincoff AM, Lavelle TA, et al. Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: results from the REPLACE-2 trial. J Am CollCardiol. 2004 Nov 2;44(9):1792-800.<br />Rassen JA, et al. Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention. EHJ. 2010; 31 (5): 561-572.<br />

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