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Statin Use in Primary Prevention: A Simple Trial-Based Approach Compared With Guideline-Recommended Risk Algorithms
Kamlesh Khunti1, Hyejung Jung2, Antonio L Dans3
1Leicester Diabetes Centre, Leicester General Hospital, Leicester, United Kingdom.
Insights
Cardiovascular risk assessment tools like the ACC/AHA and Framingham Risk Score may not be necessary for identifying individuals who benefit from statin therapy. The HOPE-3 trial demonstrated that simple clinical characteristics can identify intermediate-risk patients for preventative treatment.
Area of Science:
- Cardiology
- Preventative Medicine
- Clinical Trials
Background:
- Cardiovascular disease (CVD) risk assessment tools are crucial for identifying individuals who may benefit from preventative therapies.
- The study evaluated the utility of the American College of Cardiology/American Heart Association (ACC/AHA) risk algorithm and the Framingham Risk Score (FRS) within the context of the Heart Outcomes Prevention Evaluation (HOPE)-3 trial.
Purpose of the Study:
- To compare the effectiveness of the ACC/AHA risk algorithm and FRS in predicting outcomes in a primary prevention population.
- To assess if these risk assessment tools are essential for identifying individuals who benefit from rosuvastatin therapy in the HOPE-3 study.
Main Methods:
- The study utilized data from the HOPE-3 trial, which randomized participants to receive either 10 mg of rosuvastatin or a placebo.
- Outcomes were compared between participants assessed using the ACC/AHA algorithm and FRS against the observed outcomes in the HOPE-3 trial.
- Primary outcomes included a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, with a secondary outcome additionally incorporating heart failure, cardiac arrest, and revascularization.
Main Results:
- Relative risks predicted by both the ACC/AHA algorithm and FRS were comparable to those observed in the HOPE-3 trial.
- Hazard ratios for the first coprimary outcome showed varying effectiveness across different risk categories for both tools, with absolute risk reductions also differing.
- Similar trends were observed for the second coprimary outcome, indicating nuanced performance differences between the risk assessment tools.
Conclusions:
- The pragmatic approach of the HOPE-3 trial successfully identified individuals at intermediate risk within an ethnically diverse primary prevention population who benefited from statin therapy.
- Simple clinical characteristics, as utilized in the HOPE-3 trial, may be sufficient for identifying patients for preventative statin therapy, potentially negating the need for complex risk assessment tools.
Background:
Cardiovascular disease risk assessment tools help identify individuals likely to benefit from preventative therapies. In this study we compared outcomes using the American College of Cardiology/American Heart Association (ACC/AHA) risk algorithm and the Framingham Risk Score (FRS) tool in the Heart Outcomes Prevention Evaluation (HOPE)-3 study.
Methods:
We compared outcomes using the ACC/AHA algorithm and the FRS with those seen in HOPE-3, which randomized participants to 10 mg rosuvastatin or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; second coprimary outcome additionally included heart failure, cardiac arrest, and revascularization.
Results:
Relative risks using risk scores were similar to those observed in the HOPE-3. Hazards ratios for the first coprimary outcome according to risk categories of ≤ 10%, 10%-20%, and ≥ 20% using the ACC/AHA algorithm were 0.82 (95% confidence interval [CI], 0.53-1.28), 0.72 (95% CI, 0.53-0.96), and 0.72 (95% CI, 0.55-0.93), and absolute risk reduction (ARR) of 0.18%, 1.33%, and 1.85%, respectively, over a median of 5.6 years. Corresponding results using the FRS were 0.69 (95% CI, 0.36-1.35), 0.73 (95% CI, 0.52-1.01), and 0.75 (95% CI, 0.60- 0.94); and ARR of 1.32%, 0.61%, and 1.43%. Hazard ratios for the second coprimary outcome were 0.77 (95% CI, 0.51-1.14), 0.73 (95% CI, 0.56-0.95), and 0.74 (95% CI, 0.58-0.94); and ARR of 0.36%, 1.49%, and 1.85%, using the ACC/AHA algorithm and 0.76 (95% CI, 0.41-1.41), 0.70 (95% CI, 0.52-0.95), and 0.76 (95% CI, 0.62-0.94); and ARR of 1.08%, 0.83%, and 1.56% using the FRS.
Conclusions:
The pragmatic HOPE-3 trial approach identifies in an ethnically diverse primary prevention population individuals at intermediate risk who benefit from statin therapy using simple clinical characteristics without the need for complex, currently used risk assessment tools.
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