Prediction of 1-Year Mortality and Impact of Bivalirudin Therapy According to Level of Baseline Risk: A Patient-Level Pooled Analysis From Three Randomized Trials

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 intege-rrisk 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. (C) 2015 Wiley Periodicals, Inc.