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Lower LDL Longer Is Better for Stroke Prevention
LOS ANGELES -- Longer time at a lower low-density lipoprotein (LDL) target appeared to improve secondary prevention in stroke survivors, an analysis of the Treat Stroke to Target trial showed.
Targeting 70 mg/dL reduced composite risk of ischemic stroke, myocardial infarction, new symptoms leading to urgent coronary or carotid revascularization, or death from cardiovascular causes of 9.6% compared with 12.9% for patients randomized to a 90-110 mg/dL target (P=0.019).
That hazard ratio of 0.74 at a median 5.3 years of follow-up was just slightly better than the 0.78 seen at median 3.5 years (8.5% vs 10.9%, P=0.04) as had been reported at the American Heart Association meeting in November.
As there was no significant increase in intracranial hemorrhage (13 vs 11 cases, HR 1.17, 95% CI 0.53-2.62), the number needed to treat was 30 for both the primary composite endpoint and the net benefit pooling the two together, reported Pierre Amarenco, MD, of Bichat Hospital in Paris, here at the International Stroke Conference and online in Stroke.
There had been some "hand-wringing" about hemorrhage risk based on the 2006 SPARCL trial's finding of a small increase in those events with statin use after a recent stroke or transient ischemic attack, commented Jeremy Payne, MD, PhD, director of the Stroke Center at Banner-University Medicine Neuroscience Institute in Phoenix.
The new findings are "further reassurance that the SPARCL result may have reflected that patient population perhaps more than the effect of statins themselves" and in line with general cardiology trials showing that lipid lowering with statins and other agents (e.g., PCSK9 inhibitors) to targets much lower than 70 mg/dL didn't cause harm, he added.
"Amarenco's paper is an exciting result, and further confirms what we're already doing, providing evidence that we're on the right track by being as aggressive as we can be with lipid lowering," Payne concluded.
The earlier report from the open-label trial of 2,860 French and South Korean patients with prior ischemic stroke of documented atherosclerotic origin was based on a median of 5.3 years of follow-up in the French participants and 2.0 years in the South Korean participants before the trial was stopped early for lack of funding.
The exploratory analysis included only the French cohort of 1,073 patients. In that group, LDL achieved over the full 5.3 years was on par with what was reported in the main findings with median 3.5 years, at 66 mg/dL in the lower LDL target group and 96 mg/dL on average with the standard target.
All patients were on a moderate or intense dose of statin (with the specific agent and dose at the physician's discretion); ezetimibe (Zetia) was added to achieve the lower target in 29.2% at 6 months and escalated to 44.0% at year 3, whereas the rate was 5% to 7.9% in the looser target group.
Outcome event curves separated immediately in the first year, which differed from the main SPARCL trial results where the curves separated in favor of a high-dose statin after 2 years, the researchers noted.
Among secondary results, cerebral infarction or urgent carotid revascularization following transient ischemic attack was reduced by 27% (P=0.046). Cerebral infarction or intracranial hemorrhage dropped 28% (P=0.023).
"This result was obtained ... while other risk factors were also treated to optimal target -- blood pressure was 135/75 mm Hg on average throughout the trial, and active smokers being 30% at baseline and 5% over the course of the trial, HbA1c less than 7%," the researchers noted.
Notably, lower appeared better, as people whose average LDL cholesterol dropped below 50 mg/dL had a significant 39% relative risk reduction in the primary endpoint as compared with the 100-mg/dL target group.
Still, "stroke physicians, general practitioners, and their patients may find it useful in practice to target a number, such as less than 70 mg/dL (1.8 mmol/L), as a first objective in prevention of new stroke, as suggested by our results," Amarenco's group concluded.
The Treat Stroke to Target trial received unrestricted grants from Pfizer, AstraZeneca, and Merck as well as funding from the French Ministry of Health and SOS-Attaque Cérébrale Association.
Amarenco reported research grant support from Pfizer, Sanofi, Bristol Myers-Squibb, Merck, AstraZeneca, Boston Scientific, and the French government as well as consulting fees from Pfizer, BMS, Merck, AstraZeneca, Bayer, Daiichi-Sankyo, Boston Scientific, Kowa, GSK, FibroGen, Amgen, Shin Poong, Portola, and Gilead and lecture fees from Bayer, Amgen, and Pfizer.
Payne disclosed no relevant relationships with industry.
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