Adjustment for Atherosclerosis Diagnosis Distorts the Effects of Percutaneous Coronary Intervention and the Ranking of Hospital Performance.

BACKGROUND: Coronary atherosclerosis raises the risk of acute myocardial infarction (AMI), and is usually included in AMI risk-adjustment models. Percutaneous coronary intervention (PCI) does not cause atherosclerosis, but may contribute to the notation of atherosclerosis in administrative claims. We investigated how adjustment for atherosclerosis affects rankings of hospitals that perform PCI. METHODS AND RESULTS: This was a retrospective cohort study of 414 715 Medicare beneficiaries hospitalized for AMI between 2009 and 2011. The outcome was 30-day mortality. Regression models determined the association between patient characteristics and mortality. Rankings of the 100 largest PCI and non-PCI hospitals were assessed with and without atherosclerosis adjustment. Patients admitted to PCI hospitals or receiving interventional cardiology more frequently had an atherosclerosis diagnosis. In adjustment models, atherosclerosis was associated, implausibly, with a 42% reduction in odds of mortality (odds ratio=0.58, P<0.0001). Without adjustment for atherosclerosis, the number of expected lives saved by PCI hospitals increased by 62% (P<0.001). Hospital rankings also changed: 72 of the 100 largest PCI hospitals had better ranks without atherosclerosis adjustment, while 77 of the largest non-PCI hospitals had worse ranks (P<0.001). CONCLUSIONS: Atherosclerosis is almost always noted in patients with AMI who undergo interventional cardiology but less often in medically managed patients, so adjustment for its notation likely removes part of the effect of interventional treatment. Therefore, hospitals performing more extensive imaging and more PCIs have higher atherosclerosis diagnosis rates, making their patients appear healthier and artificially reducing the expected mortality rate against which they are benchmarked. Thus, atherosclerosis adjustment is detrimental to hospitals providing more thorough AMI care.

Cost-effectiveness of sacubitril/valsartan in the treatment of heart failure with reduced ejection fraction.

OBJECTIVE: Chronic heart failure with reduced ejection fraction (HF-REF) represents a major public health issue and is associated with considerable morbidity and mortality. We evaluated the cost-effectiveness of sacubitril/valsartan (formerly LCZ696) compared with an ACE inhibitor (ACEI) (enalapril) in the treatment of HF-REF from the perspective of healthcare providers in the UK, Denmark and Colombia. METHODS: A cost-utility analysis was performed based on data from a multinational, Phase III randomised controlled trial. A decision-analytic model was developed based on a series of regression models, which extrapolated health-related quality of life, hospitalisation rates and survival over a lifetime horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). RESULTS: In the UK, the cost per quality-adjusted life-year (QALY) gained for sacubitril/valsartan (using cardiovascular mortality) was £17 100 (€20 400) versus enalapril. In Denmark, the ICER for sacubitril/valsartan was Kr 174 000 (€22 600). In Colombia, the ICER was COP$39.5 million (€11 200) per QALY gained. Deterministic sensitivity analysis showed that results were most sensitive to the extrapolation of mortality, duration of treatment effect and time horizon, but were robust to other structural changes, with most scenarios associated with ICERs below the willingness-to-pay threshold for all three country settings. Probabilistic sensitivity analysis suggested the probability that sacubitril/valsartan was cost-effective at conventional willingness-to-pay thresholds was 68%-94% in the UK, 84% in Denmark and 95% in Colombia. CONCLUSIONS: Our analysis suggests that, in all three countries, sacubitril/valsartan is likely to be cost-effective compared with an ACEI (the current standard of care) in patients with HF-REF.