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Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention

Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention . JA Rassen, MA Mittleman, RJ Glynn, A Brookhart, S Schneeweiss

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Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention

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  1. Safety and effectiveness of bivalirudin in routine care of patients undergoing percutaneous coronary intervention JA Rassen, MA Mittleman, RJ Glynn, A Brookhart, S Schneeweiss Dept of Pharmacoepidemiology and Pharmacoeconomics, Brigham & Women’s Hospital; Depts of Epidemiology and Biostatistics, Harvard School of Public Health; Beth Israel Deaconess Eur Heart J, Nov 25, 2009

  2. Objectives • Bivalirudin has been studied as an alternative to heparin plus GP IIb/IIIa inhibitor during PCI; trials have indicated that bivalirudin is non-inferior to heparin with respect to death and repeat revascularization and may decrease the risk of major bleeds. • To evaluate the effectiveness and safety of bivalirudin as used in routine care (transfusion, repeat PCI and death) • Authors supported by Agency for Healthcare Research and Quality, National Institute of Aging, and National Institute of Mental Health 2 Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  3. Methodology: • A total of 127,185 PCI procedures were identified from the database between June 2003 through December 2006 • Patient groups were defined as having received either bivalirudin plus provisional GPIIb/IIIa or the comparator, heparin plus GPIIb/IIIa • Primary outcome: blood transfusion (whole blood, RBC, FFP, platelets, cryoprecipitate) • Secondary outcomes: in hospital mortality and repeat PCI within the same hospital admission Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  4. Patient Population • Patients with their first inpatient admission between • June 2003 and December 2006 in which they underwent PCI • (N= 326 556) • Recorded charge for bivalirudin (+/- GPI) with no heparin OR • Heparin (at least 1000 U) + GPI • Exclusions • Outpatient procedures • Rural hospitals, or those with < 2 PCI/day average • No record of antithrombotic treatment, other antithrombotic regimen or GPI only • History of hemostatic disorders Overall Analysis Population N=127,185 Treated with bivalirudin N=32, 541 (26%) Treated with heparin+ GPI N=94,644 (74%) Data on file. Premier Perspective™ Database. Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  5. Methodology: statistical analysis Adjusted for: • Patients’ socio-demographic factors: age, sex, race, income, and married or living with partner vs. living alone, year of admission, urgent admission basis. • Patient co-morbidities: diabetes, hypertension, liver disease, COPD/asthma, cancer, smoking, old MI, old stroke, endocarditis, ischaemic heart disease, peripheral artery disease, and chronic kidney disease. • Hospital factors: teaching vs. non-teaching status, location (midwest, northeast, south, or west of the USA, and urban/rural), hospital size (number of beds), and high volume hospitals (an average of 10 or more PCIs performed per day). Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  6. Methodology: statistical analysis • Primary analysis: estimated unadjusted and adjusted hazard ratios (Cox proportional hazards models); • Secondary analysis: examined cumulative incidence on the risk difference (least squares) and odds ratio (logistic regression) scales. • Sensitivity analyses for urgency of PCI/elective PCI, and for heparin alone group • Instrumental variable analysis conducted using hospital preference for treatment of PCI patients with bivalirudin Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  7. Results • Percentage of hospitals reaching threshold of administering bivalirudin to <5% and >80%of patients receiving PCI, and hospitals administering bivalirudin to >1% of those patients Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  8. Results • By quarter of calendar time, % of PCI patients exposed to bivalirudin in hospitals in the Premier Perspective Database. Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  9. Hazards Ratio ± 95% CI Results: Transfusion* OR (95% CI) Unadjusted 0.93 (0.85–1.00) 0.77 (0.69–0.86) Unadjusted IV subpopulation 0.67 (0.61–0.73) Fully adjusted Bivalirudin Better Heparin + GP IIb/IIIa Inhibitor Better 0.72 (0.12–4.47) Instrumental variable analysis * At least one unit of any blood product 10 Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  10. Hazard Ratio ± 95% CI Results: Repeat PCI OR (95% CI) Unadjusted 0.83 (0.78–0.89) 0.82 (0.76–0.89) Unadjusted IV subpopulation 0.96 (0.90–1.03) Fully adjusted Bivalirudin Better Heparin + GP IIb/IIIa Inhibitor Better 0.83 (0.49–1.40) Instrumental variable analysis 11 Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  11. Hazard Ratio ± 95% CI Results: Death OR (95% CI) • In-hospital mortality rate: bivalirudin 0.8%, 2.1% heparin + GPI Unadjusted 0.57 (0.49–0.65) 0.56 (0.46–0.66) Unadjusted IV subpopulation 0.51 (0.44–0.60) Fully adjusted Bivalirudin Better Heparin + GP IIb/IIIa Inhibitor Better 0.51 (0.34–0.78) Instrumental variable analysis 12 Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  12. Results • Hazard ratio point estimates and standard errors for models of mortality in the Premier and clinical trial databases Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

  13. Conclusions • Bivalirudin is protective compared to heparin plus GPI with regard to the risk of blood transfusions and death • Mortality benefit may even exceed trial estimates • Because of conventional analyses’ potential for bias as a result of residual confounding, IVA-based methods, with their known limitations, may help in studying the safety and effectiveness of medications outside the constrained setting of clinical trials. Rassen JA et al Eur Heart J 2009 On line ahead of print Nov 25 doi:10.1093/eurheartj/ehp437

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