Jennifer Yu1,2, Roxana Mehran1,3, Tim Clayton4, C Michael Gibson5, Bruce R Brodie6, Bernhard Witzenbichler7, A Michael Lincoff8, Efthymios N Deliargyris9, Bernard J Gersh10, Stuart J Pocock4, Gregg W Stone3,11, George D Dangas1,3. 1. Mount Sinai Medical Center, Cardiovascular Institute, New York, New York. 2. Prince of Wales Hospital Clinical School, University of New South Wales, NSW, Australia. 3. Cardiovascular Research Foundation, New York, New York. 4. London School of Hygiene and Tropical Medicine, London, United Kingdom. 5. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. 6. LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina. 7. Helios Amper-Klinikum, Dachau, Germany. 8. Cleveland Clinic, Cleveland, Ohio. 9. The Medicines Company, Munich, Germany. 10. Mayo Clinic, Rochester, Minnesota. 11. Columbia University Medical Center, New York, New York.
Abstract
OBJECTIVES: We aimed to construct a predictive model for one-year mortality in patients undergoing invasive coronary evaluation and to examine the impact of bivalirudin on survival according to the level of baseline risk. BACKGROUND: Compared to heparin plus GP IIb/IIIa inhibitors (HEP/GPI), bivalirudin decreases bleeding complications in a range of clinical presentations. The impact of preprocedural risk assessment on survival and whether this is modified by bivalirudin, has not been investigated in detail. METHODS: We examined patient-level data from the REPLACE-2, ACUITY, and HORIZONS-AMI trials (n = 18,819) to construct a risk-adjusted mortality model using baseline clinical variables. RESULTS:One-year mortality occurred in 287 patients (3.1%) assigned to bivalirudin and 336 patients (3.6%) assigned to HEP/GPI (HR 0.85; 95% CI, 0.73-1.00; P = 0.048). Using 11 highly significant predictors of mortality, we developed an integer-risk score to classify patients into risk tertiles. High-risk patients had a rate of 1-year mortality over 9-fold greater than low-risk patients. Consequently, the absolute mortality reduction attributed to bivalirudin was more marked in high-risk patients: 3.1% (-0.8% to 7.0%) in the overall cohort, 4.8% (0.5% to 9.2%) in the PCI cohort (P-interaction versus intermediate and low risk categories, 0.09 and P = 0.02, respectively). CONCLUSIONS: In patients undergoing invasive coronary evaluation, 1-year mortality can be predicted using baseline variables. Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit.
RCT Entities:
OBJECTIVES: We aimed to construct a predictive model for one-year mortality in patients undergoing invasive coronary evaluation and to examine the impact of bivalirudin on survival according to the level of baseline risk. BACKGROUND: Compared to heparin plus GP IIb/IIIa inhibitors (HEP/GPI), bivalirudin decreases bleeding complications in a range of clinical presentations. The impact of preprocedural risk assessment on survival and whether this is modified by bivalirudin, has not been investigated in detail. METHODS: We examined patient-level data from the REPLACE-2, ACUITY, and HORIZONS-AMI trials (n = 18,819) to construct a risk-adjusted mortality model using baseline clinical variables. RESULTS: One-year mortality occurred in 287 patients (3.1%) assigned to bivalirudin and 336 patients (3.6%) assigned to HEP/GPI (HR 0.85; 95% CI, 0.73-1.00; P = 0.048). Using 11 highly significant predictors of mortality, we developed an integer-risk score to classify patients into risk tertiles. High-risk patients had a rate of 1-year mortality over 9-fold greater than low-risk patients. Consequently, the absolute mortality reduction attributed to bivalirudin was more marked in high-risk patients: 3.1% (-0.8% to 7.0%) in the overall cohort, 4.8% (0.5% to 9.2%) in the PCI cohort (P-interaction versus intermediate and low risk categories, 0.09 and P = 0.02, respectively). CONCLUSIONS: In patients undergoing invasive coronary evaluation, 1-year mortality can be predicted using baseline variables. Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit.
Authors: Christoph B Olivier; Vandana Sundaram; Deepak L Bhatt; Sergio Leonardi; Renato D Lopes; Victoria Y Ding; Lingyao Yang; Gregg W Stone; Ph Gabriel Steg; C Michael Gibson; Christian W Hamm; Matthew J Price; Harvey D White; Manisha Desai; Donald R Lynch; Robert A Harrington; Kenneth W Mahaffey Journal: Int J Cardiol Date: 2018-06-08 Impact factor: 4.164