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Personalized absolute benefit of statin treatment for primary or secondary prevention of vascular disease in individual elderly patients.

ABSTRACT: OBJECTIVE:To estimate the absolute treatment effect of statin therapy on major adverse cardiovascular events (MACE; myocardial infarction, stroke and vascular death) for the individual patient aged ?70 years. METHODS:Prediction models for MACE were derived in patients aged ?70 years with (n = 2550) and without (n = 3253) vascular disease from the "PROspective Study of Pravastatin in Elderly at Risk" (PROSPER) trial and validated in the "Secondary Manifestations of ARTerial disease" (SMART) cohort study (n = 1442) and the "Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm" (ASCOT-LLA) trial (n = 1893), respectively, using competing risk analysis. Prespecified predictors were various clinical characteristics including statin treatment. Individual absolute risk reductions (ARRs) for MACE in 5 and 10 years were estimated by subtracting on-treatment from off-treatment risk. RESULTS:Individual ARRs were higher in elderly patients with vascular disease [5-year ARRs: median 5.1 %, interquartile range (IQR) 4.0-6.2 %, 10-year ARRs: median 7.8 %, IQR 6.8-8.6 %] than in patients without vascular disease (5-year ARRs: median 1.7 %, IQR 1.3-2.1 %, 10-year ARRs: 2.9 %, IQR 2.3-3.6 %). Ninety-eight percent of patients with vascular disease had a 5-year ARR ?2.0 %, compared to 31 % of patients without vascular disease. CONCLUSIONS:With a multivariable prediction model the absolute treatment effect of a statin on MACE for individual elderly patients with and without vascular disease can be quantified. Because of high ARRs, treating all patients is more beneficial than prediction-based treatment for secondary prevention of MACE. For primary prevention of MACE, the prediction model can be used to identify those patients who benefit meaningfully from statin therapy.

SUBMITTER: Stam-Slob MC

PROVIDER: S-EPMC5226996 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Personalized absolute benefit of statin treatment for primary or secondary prevention of vascular disease in individual elderly patients.

Stam-Slob Manon C MC Visseren Frank L J FL Wouter Jukema J J van der Graaf Yolanda Y Poulter Neil R NR Gupta Ajay A Sattar Naveed N Macfarlane Peter W PW Kearney Patricia M PM de Craen Anton J M AJ Trompet Stella S

Clinical research in cardiology : official journal of the German Cardiac Society 20160823 1

<h4>Objective</h4>To estimate the absolute treatment effect of statin therapy on major adverse cardiovascular events (MACE; myocardial infarction, stroke and vascular death) for the individual patient aged ≥70 years.<h4>Methods</h4>Prediction models for MACE were derived in patients aged ≥70 years with (n = 2550) and without (n = 3253) vascular disease from the "PROspective Study of Pravastatin in Elderly at Risk" (PROSPER) trial and validated in the "Secondary Manifestations of ARTerial disease ...[more]

PMID: 27554244

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Project description:Genetic variants have been associated with the risk of coronary heart disease. In this study, we tested whether or not a composite of these variants could ascertain the risk of both incident and recurrent coronary heart disease events and identify those individuals who derive greater clinical benefit from statin therapy.A community-based cohort study (the Malmo Diet and Cancer Study) and four randomised controlled trials of both primary prevention (JUPITER and ASCOT) and secondary prevention (CARE and PROVE IT-TIMI 22) with statin therapy, comprising a total of 48,421 individuals and 3477 events, were included in these analyses. We studied the association of a genetic risk score based on 27 genetic variants with incident or recurrent coronary heart disease, adjusting for traditional clinical risk factors. We then investigated the relative and absolute risk reductions in coronary heart disease events with statin therapy stratified by genetic risk. We combined data from the different studies using a meta-analysis.When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient in risk for incident or recurrent coronary heart disease was shown. Compared with the low genetic risk category, the multivariable-adjusted hazard ratio for coronary heart disease for the intermediate genetic risk category was 1·34 (95% CI 1·22-1·47, p<0·0001) and that for the high genetic risk category was 1·72 (1·55-1·92, p<0·0001). In terms of the benefit of statin therapy in the four randomised trials, we noted a significant gradient (p=0·0277) of increasing relative risk reductions across the low (13%), intermediate (29%), and high (48%) genetic risk categories. Similarly, we noted greater absolute risk reductions in those individuals in higher genetic risk categories (p=0·0101), resulting in a roughly threefold decrease in the number needed to treat to prevent one coronary heart disease event in the primary prevention trials. Specifically, in the primary prevention trials, the number needed to treat to prevent one such event in 10 years was 66 in people at low genetic risk, 42 in those at intermediate genetic risk, and 25 in those at high genetic risk in JUPITER, and 57, 47, and 20, respectively, in ASCOT.A genetic risk score identified individuals at increased risk for both incident and recurrent coronary heart disease events. People with the highest burden of genetic risk derived the largest relative and absolute clinical benefit from statin therapy.National Institutes of Health.

Project description:ImportanceA 10-year benefit-based approach to statin therapy in primary prevention includes younger individuals with higher low-density lipoprotein cholesterol (LDL-C) and prevents more cardiovascular events than a risk-based approach. However, a 10-year treatment duration likely underestimates the expected benefits of statins.ObjectiveTo model the impact of a 30-year benefit approach to select individuals for statin therapy.Design, setting, and participantsThis cross-sectional analysis of the National Health and Nutrition Survey (NHANES) data set included samples of the US population from the 2009-2010, 2011-2012, and 2013-2014 data collection cycles. Individuals between 40 to 60 years old who did not have atherosclerotic cardiovascular disease, diabetes, or LDL-C levels greater than 190 mg/dL and who were not taking statins were included. Data analysis took place from November 2017 to August 2018.ExposuresWe calculated 10-year risk of atherosclerotic cardiovascular disease and 10-year and 30-year absolute risk reduction (10-year ARR and 30-year ARR) of atherosclerotic cardiovascular disease for each individual.Main outcomes and measuresNumber of individuals meeting eligibility for statins based on 10-year (atherosclerotic) cardiovascular disease risk, 10-year ARR, or 30-year ARR.ResultsA total of 1688 individuals were included, representing 56.6 million US individuals. Statin eligibility based on 7.5% CVR10 was 9.5%; based on 2.3% 10-year ARR, 13.0%, and based on 15% 30-year ARR, 17.5%. The 10-year risk, 10-year benefit, and 30-year benefit approaches all led to similar acceptable mean absolute risk reductions at 30 years, with the benefit-based approaches better able to avoid treatment of individuals with low expected benefit. Individuals who met statin eligibility based solely on the 30-year ARR threshold of 15% or greater were younger (mean age, 50 [95% CI, 48-52] years) and more likely to be women (43% [95% CI, 26%-59%]) than those recommended with a 10-year ARR threshold of 2.3% or greater (mean age, 56 [95% CI, 54-57] years; 22% [95% CI, 10%-34%] women). This group also had lower 10-year risk (mean risk, 4.7% [95% CI, 4.4%-5.1%]) and higher LDL-C levels (mean level, 149 mg/dL [95% CI, 142-155 mg/dL]) than those recommended with a 10-year ARR threshold of 2.3% or greater (mean risk, 9.3% [95% CI, 8.3%-10.2%]; mean LDL-C levels, 110 [103-118] mg/dL). Preventable atherosclerotic cardiovascular disease events in 10 and 30 years were highest using the 30-year benefit approach (296 000 at 10 years and 2.03 million at 30 years) and lowest based on 10-year risk (204 000 at 10 years and 1.18 million at 30 years).Conclusions and relevanceA long-term benefit approach to statin eligibility identifies nearly 1 in 6 individuals as having a high degree of expected long-term benefit of statins, with a number needed to treat of less than 7. This approach identifies younger individuals with higher LDL-C levels who would not be currently recommended for treatment and may provide a more optimal approach for determining statin eligibility in primary prevention.

Project description:BackgroundLow-dose aspirin is of definite and substantial net benefit for many people who already have occlusive vascular disease. We have assessed the benefits and risks in primary prevention.MethodsWe undertook meta-analyses of serious vascular events (myocardial infarction, stroke, or vascular death) and major bleeds in six primary prevention trials (95,000 individuals at low average risk, 660,000 person-years, 3554 serious vascular events) and 16 secondary prevention trials (17,000 individuals at high average risk, 43,000 person-years, 3306 serious vascular events) that compared long-term aspirin versus control. We report intention-to-treat analyses of first events during the scheduled treatment period.FindingsIn the primary prevention trials, aspirin allocation yielded a 12% proportional reduction in serious vascular events (0.51% aspirin vs 0.57% control per year, p=0.0001), due mainly to a reduction of about a fifth in non-fatal myocardial infarction (0.18%vs 0.23% per year, p<0.0001). The net effect on stroke was not significant (0.20%vs 0.21% per year, p=0.4: haemorrhagic stroke 0.04%vs 0.03%, p=0.05; other stroke 0.16%vs 0.18% per year, p=0.08). Vascular mortality did not differ significantly (0.19%vs 0.19% per year, p=0.7). Aspirin allocation increased major gastrointestinal and extracranial bleeds (0.10%vs 0.07% per year, p<0.0001), and the main risk factors for coronary disease were also risk factors for bleeding. In the secondary prevention trials, aspirin allocation yielded a greater absolute reduction in serious vascular events (6.7%vs 8.2% per year, p<0.0001), with a non-significant increase in haemorrhagic stroke but reductions of about a fifth in total stroke (2.08%vs 2.54% per year, p=0.002) and in coronary events (4.3%vs 5.3% per year, p<0.0001). In both primary and secondary prevention trials, the proportional reductions in the aggregate of all serious vascular events seemed similar for men and women.InterpretationIn primary prevention without previous disease, aspirin is of uncertain net value as the reduction in occlusive events needs to be weighed against any increase in major bleeds. Further trials are in progress.FundingUK Medical Research Council, British Heart Foundation, Cancer Research UK, and the European Community Biomed Programme.

Project description:BackgroundBenefit-targeted statin prescribing may be superior to risk-targeted statin prescribing (the current standard), but the impact and efficiency of this approach are unclear.Methods and resultsWe analyzed the National Health and Nutrition Examination Survey (NHANES) using an open-source model (the Prevention Impact and Efficiency Model) to compare targeting of statin therapy according to expected benefit (benefit-targeted) versus baseline risk (risk-targeted) in terms of projected population-level impact and efficiency. Impact was defined as relative % reduction in atherosclerotic cardiovascular disease in the US population for the given strategy compared to current statin treatment patterns; and efficiency as the number needed to treat over 10 years (NNT10, average and maximum) to prevent each atherosclerotic cardiovascular disease event. Benefit-targeted moderate-intensity statin therapy at a treatment threshold of 2.3% expected 10-year absolute risk reduction could produce a 5.7% impact (95% confidence interval, 4.8-6.7). This is approximately equivalent to the potential impact of risk-targeted therapy at a treatment threshold of 5% 10-year atherosclerotic cardiovascular disease risk (5.6% impact [4.7-6.6]). Whereas the estimated maximum NNT10 is much improved for benefit-targeted versus risk-targeted therapy at these equivalent-impact thresholds (43.5 vs 180), the average NNT10 is nearly equivalent (24.2 vs 24.6). Reaching 10% impact (half the Healthy People 2020 impact objective, loosely defined) is theoretically possible with benefit-targeted moderate-intensity statins of persons with expected absolute risk reduction >2.3% if we expand age eligibility and account for treatment of all persons with diabetes mellitus or with low-density lipoprotein >190 mg/dL (impact=12.4%; average NNT10=23.0).ConclusionsBenefit-based targeting of statin therapy provides modest gains in efficiency over risk-based prescribing and could theoretically help attain approximately half of the Healthy People 2020 impact goal with reasonable efficiency.

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Personalized absolute benefit of statin treatment for primary or secondary prevention of vascular disease in individual elderly patients.

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Personalized absolute benefit of statin treatment for primary or secondary prevention of vascular disease in individual elderly patients.

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