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About
Statins are among the most widely used drugs. While they were found to be effective for primary and secondary prevention of cardiovascular disease (CVD) in middle-aged subjects, their benefits for primary prevention in older adults (aged ≥70 years) without CVD are uncertain, particularly for those with multimorbidity. To better target adults who may benefit from statins in primary prevention, coronary artery calcium (CAC) measurement is rapidly increasing in clinical use and is recommended for risk re-classification in some guidelines. Older patients with a high burden of subclinical atherosclerosis might benefit from continuing statins to prevent CV outcomes, but this hypothesis has not been rigorously tested in randomized clinical trials (RCTs). To address these questions, the investigators conduct a RCT in 500 multimorbid adults ≥70 years old taking statins for primary prevention who will be randomized to statin continuation vs. statin discontinuation, and measure baseline CAC to determine if the risk of a composite outcome of CV events and all-cause mortality after statin discontinuation differs among those with evidence of subclinical atherosclerosis at baseline as measured by CAC.
Full description
Background & rationale: The benefit of statin use for primary prevention is uncertain in older adults with multimorbidity, while harms such as side effects may be more common in this population. Therefore, the 2018 AHA/ACC cholesterol guidelines mention that it may be reasonable to discontinue statins in multimorbid older adults without cardiovascular disease (CVD). To better target adults who may benefit from statins in primary prevention, coronary artery calcium (CAC) measurement is rapidly increasing in clinical use and is recommended for risk re-classification in some guidelines. Older patients with a high burden of subclinical atherosclerosis associated with cardiovascular (CV) risk might benefit from continuing statins to prevent CV outcomes, but this hypothesis has not been rigorously tested in randomized clinical trials (RCTs). To address this question, the investigators conduct a RCT in 500 multimorbid adults ≥70 years old taking statins for primary prevention who will be randomized to statin continuation vs. statin discontinuation, and measure baseline CAC to determine if the risk of a composite outcome of CV events and all-cause mortality after statin discontinuation differs among those with evidence of subclinical atherosclerosis at baseline as measured by CAC.
Specific aim:
To determine if the risk of a composite outcome of CV events and all-cause mortality after statin discontinuation differs among those with evidence of subclinical atherosclerosis at baseline as measured by CAC.
Design:
The study is a multicenter, randomized, non-inferiority trial conducted in multiple centers in Switzerland. Study subjects are randomly assigned in a 1:1 ratio to either discontinue (intervention arm) or continue (control arm) statin therapy. The study is open-label, with blinded outcome adjudication. After inclusion the study participants will be followed with phone calls, first after 3 months and then yearly for a mean of 24 months (min. follow-up period 12 months, max. follow-up period 48 months). Outcomes are assessed at each study follow-up. The investigators will use baseline native cardiac computed tomography scan to measure CAC to identify participants with subclinical atherosclerosis.
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Inclusion criteria
Exclusion criteria
Secondary prevention based on previous large statin trials, defined as:
Aortic disease that required a vascular repair or aortic aneurysm with a maximum diameter >5.5 cm (men) or >5.2 cm (women) based on available documents
Diagnosis of familial hypercholesterolemia based on Dutch lipid score ≥6 based on available documents (LDL-c, Family History, Personal History)
Elevated risk of death within 3 months after baseline, defined as:
Body measures exceeding the CT scanner limits (morbid obesity exceeding weight and diameter limits)
Cardiac implants with metallic interference, such as pacemaker and mechanical heart valves
Orthopedic hardware in the mid or lower thoracic spine
Inability to hold breath for 10 seconds
Primary purpose
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Interventional model
Masking
500 participants in 2 patient groups
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Central trial contact
Manuel R Blum, MD, MSc; Nicolas Rodondi, MD, MAS
Data sourced from clinicaltrials.gov
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