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Purpose

Comparison of bivalirudin versus heparin(s) during percutaneous coronary intervention in patients receiving prasugrel. Martial Hamon 1 , Steven Marso 2 , Sunil Rao 3 , Marco Valgimigli 4 , Freek Verheugt 5 , Anthony Gershlick 6 , Yamei Wang 8 , Gabriel Steg 7 , Efthymios Deliargyris 8

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Purpose

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  1. Comparison of bivalirudin versus heparin(s) during percutaneous coronary intervention in patients receiving prasugrel Martial Hamon1, Steven Marso2, Sunil Rao3, Marco Valgimigli4, Freek Verheugt5, Anthony Gershlick6, Yamei Wang8, Gabriel Steg7, Efthymios Deliargyris8 Institutions: 1. Centre HospitalierUniversitaire de Caen, France. 2. Saint Luke's Mid America Heart Institute, University of Missouri–Kansas City, Kansas City, MO. 3. Duke Clinical Research Institute, Durham, NC. 4. Department of Interventional Cardiology, Cardiovascular Institute, University of Ferrara, Ferrara, Italy. 5. Radboud University Medical Centre, Nijmegen, the Netherlands. 6. University of Leicester, Glenfield Hospital, Leicester, United Kingdom. 7. INSERM U-698, AP-HP and Université Paris 7, Paris, France. 8. The Medicines Company, Parsippany NJ, USA.

  2. Purpose • Bivalirudin (BIV) has been established as Class I therapy in the ESC/EACTS guidelines for anticoagulation in PCI for moderate to high risk NSTE-ACS and STE-ACS patients. • Antiplatelet agents are used as adjunctive agents with BIV or unfractionated or low molecular weight heparin (HEP) ± glycoprotein IIb/IIIa inhibitor (GPI) in PCI. • Prasugrel (PRAS) is a recently introduced agent and thus little data is available regarding the use of PRAS with BIV.

  3. Observational database background • The Premier Perspective Database: • A comprehensive repository of clinical, financial, and outcomes information that undergo routine quality and completeness checks including data verification, reconciliation, and validation • Used by the FDA for drug surveillance and by CMS to evaluate next-generation payment models • Over 5 million inpatient discharges and over 30 million hospital outpatient visits are recorded annually; approximately 1/6 of all US hospitalizations • Potential to allow greater insight on comparative effectiveness issues

  4. Premier analysis- patient population

  5. Methods • Using the Premier Perspective database, 6986 patients who underwent elective, urgent, or primary PCI between Q3 2009 and Q4 2010 from 166 US hospitals were identified. • Patients were treated with either BIV (n=3377) or HEP± GPI (n=3609) on the day of PCI and given PRAS before or on the day of PCI. • Outcomes of interest included bleeding, transfusion, death, and hospital length of stay. • To control for patient and hospital level characteristics, a 1:1 propensity score matching analysis was performed (PSM1). • PSM2 was performed to eliminate patients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization). • Differences between the treatment groups before and after PSM were presented using descriptive statistics, including unadjusted odds ratio (OR) and 95% confidence interval (CI).

  6. Baseline characteristics • 6896 patients receiving bivalirudin or heparin+GPI for PCI • Prasugrel was given on the day of PCI in both groups

  7. Baseline characteristics • Propensity score -matched populations • PSM 1= 1:1 propensity score matched; PSM 2= eliminates patients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization

  8. Results 1-2: Clinically apparent bleeding • In- hospital outcomes BIV better HEP± GPI better PSM 1= 1:1 propensity score matched; PSM 2= eliminates patients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization

  9. Clinically apparent bleeding requiring transfusion • In- hospital outcomes BIV better HEP± GPI better PSM 1= 1:1 propensity score matched; PSM 2= eliminates patients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization

  10. Results 3-5: Any transfusion • In- hospital outcomes BIV better HEP ± GPI better PSM 1= 1:1 propensity score matched; PSM 2= eliminates patients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization

  11. Death • In- hospital outcomes BIV better HEP ± GPI better PSM 1= 1:1 propensity score matched; PSM 2= eliminates patients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization

  12. Length of hospital stay PSM 1= 1:1 propensity score matched; PSM 2= eliminatespatients in whom the use of PRAS increases the risk of bleeding, (age> 75 years, prior stroke/TIA, low body weight, and CABG in the same hospitalization

  13. Conclusions • In this analysis of real world data, patients receiving bivalirudin and prasugrelhad fewer transfusions than with HEP ± GPI and a shorter length of hospital stay.

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