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March 17, 2020
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Atorvastatin may reduce total vascular events after stroke

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New findings from the SPARCL trial showed that patients with prior stroke or transient ischemic attack experienced fewer total vascular events, including cerebrovascular, coronary and peripheral events, when treated with atorvastatin compared with placebo.

According to research on the program at the American College of Cardiology Scientific Session, 4,731 patients with stroke or TIA 1 to 6 months before trial initiation, LDL of 100 mg/dL to 190 mg/dL and no history of CHD were randomly assigned to atorvastatin 80 mg or placebo once daily.

Vascular events included nonstroke vascular death; nonfatal MI; unstable angina; hospitalization for angina or ischemia; resuscitation after cardiac arrest; coronary, carotid or peripheral revascularization; clinically significant peripheral vascular disease; and nonvascular death. In the main results of SPARCL, the atorvastatin group had less first occurrence of stroke and less first occurrence of vascular events (HR = 0.73; 95% CI, 0.66-0.82) compared with the placebo group.

During 6 years of follow-up, patients assigned atorvastatin experienced 32% total fewer vascular events (HR = 0.68; 95% CI, 0.6-0.77) compared with patients assigned placebo.

In addition, compared with the placebo group, the atorvastatin group had 24% fewer cerebrovascular events (HR = 0.76; 95% CI, 0.66-0.88), 46% fewer coronary events (HR = 0.54; 95% CI, 0.42-0.7) and 44% fewer peripheral events (HR = 0.56; 95% CI, 0.35-0.89), according to the researchers.

According to the simultaneous publication in the Journal of the American College of Cardiology, during the 6-year period, an estimated 20 vascular events per 100 participants were avoided with atorvastatin treatment.

“The SPARCL trial demonstrated that intensive atorvastatin therapy decreases the first occurrence of stroke and first composite vascular events compared with placebo among participants with a recent stroke or transient ischemic attack and no known coronary heart disease,” Michael Szarek, PhD, associate dean for research administration and chair and professor in the department of epidemiology and biostatistics at the SUNY Downstate Health Sciences University School of Public Health, and colleagues wrote in JACC. “The present exploratory analysis illustrates that this treatment effect may be even greater when total vascular events are considered, with more than twice as many total events prevented, compared to first events prevented.”

Subgroup analyses

Additionally, atorvastatin reduced total vascular events by approximately 10% during the first year (HR = 0.9; 95% CI, 0.76-1.06) and by approximately 40% after the first year (HR = 0.6; 95% CI, 0.54-0.68).

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In a subgroup analysis of patients with a history of diabetes, atorvastatin conferred a 50% risk reduction for vascular events (HR = 0.5; 95% CI, 0.4-0.64).

“Participants with diabetes and a recent history of stroke or transient ischemic attack represents a group with an exceptionally high risk for vascular events that may derive greater relative and absolute benefit from atorvastatin treatment,” the researchers wrote.

For this trial, researchers excluded patients with atrial fibrillation, mechanical prosthetic heart valves or subarachnoid hemorrhage. Patients were scheduled for follow-up visits 1, 3 and 6 months after randomization and every 6 months thereafter until about 540 patients experienced the primary endpoint of first fatal or nonfatal stroke, at which time surviving participants attended their final visit.

Total event reduction as a gauge

“Although the efficacy of atorvastatin treatment after stroke or transient ischemic attack was established based on an analysis of time to first stroke and first vascular event, the efficiency of this intervention to reduce the total burden of disease and health care costs may be better reflected by an analysis of total events,” the researchers wrote. “These findings are consistent with the pattern observed in prior trials of statins or ezetimibe in patients with established atherosclerotic disease or acute coronary syndromes, indicating the value of evaluating any long-term lipid-lowering therapy on the basis of total event modification.” – by Scott Buzby

References:

Szarek M, et al. On the cutting edge of peripheral artery disease. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).

Szarek M, et al. J Am Coll Cardiol. 2020;doi:10.1016/j.jacc.2020.03.015.

Disclosures: Szarek reports he is a consultant for CiVi and Esperion; serves on data and safety monitoring boards for Baxter and Resverlogix; and serves on steering committees for Regeneron Pharmaceuticals and Sanofi. Please see the study for all other authors’ relevant financial disclosures.