23 research outputs found

    Late Stent Thrombosis Can it Be Prevented?βˆ—

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    Strategies for Primary Prevention of Coronary Heart Disease Based on Risk Stratification by the ACC/AHA Lipid Guidelines, ATP III Guidelines, Coronary Calcium Scoring, and C-Reactive Protein, and a Global Treat-All Strategy: A Comparative--Effectiveness Modeling Study

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    <div><p>Background</p><p>Several approaches have been proposed for risk-stratification and primary prevention of coronary heart disease (CHD), but their comparative and cost-effectiveness is unknown.</p><p>Methods</p><p>We constructed a state-transition microsimulation model to compare multiple approaches to the primary prevention of CHD in a simulated cohort of men aged 45–75 and women 55–75. Risk-stratification strategies included the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the treatment of blood cholesterol, the Adult Treatment Panel (ATP) III guidelines, and approaches based on coronary artery calcium (CAC) scoring and C-reactive protein (CRP). Additionally we assessed a treat-all strategy in which all individuals were prescribed either moderate-dose or high-dose statins and all males received low-dose aspirin. Outcome measures included CHD events, costs, medication-related side effects, radiation-attributable cancers, and quality-adjusted-life-years (QALYs) over a 30-year timeframe.</p><p>Results</p><p>Treat-all with high-dose statins dominated all other strategies for both men and women, gaining 15.7 million QALYs, preventing 7.3 million myocardial infarctions, and saving over $238 billion, compared to the status quo, far outweighing its associated adverse events including bleeding, hepatitis, myopathy, and new-onset diabetes. ACC/AHA guidelines were more cost-effective than ATP III guidelines for both men and women despite placing 8.7 million more people on statins. For women at low CHD risk, treat-all with high-dose statins was more likely to cause a statin-related adverse event than to prevent a CHD event.</p><p>Conclusions</p><p>Despite leading to a greater proportion of the population placed on statin therapy, the ACC/AHA guidelines are more cost-effective than ATP III. Even so, at generic prices, treating all men and women with statins and all men with low-dose aspirin appears to be more cost-effective than all risk-stratification approaches for the primary prevention of CHD. Especially for low-CHD risk women, decisions on the appropriate primary prevention strategy should be based on shared decision making between patients and healthcare providers.</p></div

    Sensitivity Analysis: Costs per QALY of selected* strategies compared to treat-all with high-dose statins as a function of increasing statin disutility for men and women<sup>#</sup>. 6a: Men (cost-effectiveness threshold of $50,000 per QALY gained demonstrated by the dashed line). 6b: Women.

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    <p>*Only strategies that were not dominated by treat-all with high-dose statins at 100-times basecase statin disutility are shown. #At 10-times the basecase statin disutility all strategies are more expensive and less costly than treat-all with high-dose statins, therefore they are dominated by treat-all high-dose statins and demonstrate a negative cost per QALY. At 100-times basecase statin disutility for men, status quo remains dominated by treat-all with high-dose statins and therefore retains a negative cost per QALY, while the other strategies shown are now more effective than treat-all with high-dose statins but more expensive, evidenced by a positive cost per QALY. Only JUPITER is cost-effective as compared to treat-all with high-dose statins as the cost per QALY gained via the JUPITER strategy is < $50,000 (noted by the dashed line) as compared to treat-all with high-dose statins. At 100-times basecase statin disutility for women and 1,000-times statin disutility for both men and women all strategies shown are more effective and more expensive than treat-all with high-dose statins but they are so much more effective than treat-all with high-dose statins that the cost per QALY gained is low and they are all more cost effective compared to treat-all with high-dose statins. Abbreviations same as in prior figures.</p

    Adherence Sensitivity analysis: Cost-effectiveness of strategies evaluated using an adherence rate of 19% for all non-CAC based strategies and a variable adherence rate for CAC based strategies in which the higher the CAC score the higher the adherence to therapy (women only simulation shown).

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    <p>*Texas dominates treat-all with moderate-dose statins as well as all other risk-stratification strategies. #SHAPE is not cost-effective as compared to treat-all with moderate-dose statins as the ICER of SHAPE compared to treat-all with moderate-dose statins is $95,864 per QALY gained. Abbreviations same as in prior figures.</p

    Results of basecase simulations. 3A: Men only. 3B: Women only.

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    <p>*Cost-effective as compared to less expensive AND less effective strategies with an incremental cost effectiveness ratio <50,000/QALY gained for JUPITER compared to ACC/AHA and Texas compared to ATP III. #Cost-effective as compared to less expensive AND less effective strategies with an incremental cost effectiveness ratio <50,000/QALY gained for treat-all with moderate-dose statins compared to ACC/AHA. ^Not cost-effective as compared to less expensive AND less effective strategies with an incremental cost effectiveness of ratio of > $50,000/QALY gained for both SHAPE and JUPITER compared to Texas. ICER = Incremental Cost Effectiveness Ratio. QALY = Quality-Adjusted Life Year. Other abbreviations same as in prior figures.</p

    Inclusion and Exclusion Criteria as Well as Overview of each Approach to Primary Prevention Strategies Evaluated in the Model.

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    <p>* SHAPE treats the following as risk factors: total cholesterol >200mg/dl, blood pressure >120/80, diabetes mellitus, smoking, family history of CHD, and metabolic syndrome.</p><p><sup>#</sup> Stress test deemed positive if >10% of myocardium demonstrates reversible ischemia. Positive stress test would lead to coronary angiography and if indicated coronary revascularization.</p><p>JUPITER = Justification for the Use of Statins in Primary Prevention</p><p>ATP III = Adult Treatment Panel III</p><p>SHAPE = Screening for Heart Attack Prevention and Education</p><p>YO = Years-Old</p><p>LDL-C = Low-density lipoprotein</p><p>CRP = C-Reactive Protein</p><p>FRS = Framingham Risk Score</p><p>CAC = Coronary Artery Calcium</p><p>PCE = pooled cohort risk equation</p><p>Inclusion and Exclusion Criteria as Well as Overview of each Approach to Primary Prevention Strategies Evaluated in the Model.</p

    Selected Inputs to the State-Transition Model.

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    <p>*beta distribution for probabilistic sensitivity analysis</p><p><sup>†</sup>log-normal distribution for probabilistic sensitivity analysis</p><p><sup>#</sup>The status quo simulation represents outcomes based on current statin and aspirin use in the US primary prevention population</p><p><sup>^</sup>Includes costs of adverse events</p><p>CABG = coronary artery bypass graft surgery</p><p>CAC = coronary artery calcium</p><p>CHD = coronary heart disease</p><p>CI = confidence interval</p><p>CRP = C-reactive protein</p><p>FRS = Framingham Risk Score</p><p>JUPITER = Justification for the Use of Statins in Primary Prevention study</p><p>LDL-C = low-density lipoprotein in milligrams per deciliter</p><p>mSv = milisieverts</p><p>MI = myocardial infarction</p><p>PCI = percutaneous coronary intervention</p><p>QALYs = quality adjusted life years</p><p>RR = relative risk</p><p>Selected Inputs to the State-Transition Model.</p
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