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CME

Statins Should Be a Part of Preventive Management in Stroke Patients

  • Authors: News Author: Shelley Wood
    CME Author: Charles Vega, MD, FAAFP
  • CME Released: 8/9/2006; Reviewed and Renewed: 8/9/2007
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 8/9/2008
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Target Audience and Goal Statement

This article is intended for primary care clinicians, neurologists, cardiologists, and other specialists who care for patients with a recent history of stroke.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Describe previous research of statins in the prevention of stroke.
  • Compare placebo vs atorvastatin in the treatment of adults with a recent history of TIA or stroke.


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Author(s)

  • Shelley Wood

    Shelley Wood is a journalist for Medscape. She joined theheart.org, part of the WebMD Professional Network, in 2000 and specializes in interventional cardiology. She studied literature at McGill University and the University of Cape Town and received her graduate degree in journalism from the University of British Columbia, specializing in health reporting. She can be reached at [email protected]

    Disclosures

    Disclosure: Shelley Wood has disclosed no relevant financial relationships.

CME Author(s)

  • Charles P Vega, MD

    Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

    Disclosures

    Disclosure: Charles Vega, MD, FAAFP, has disclosed that he has received grants for educational activities from Pfizer.


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CME

Statins Should Be a Part of Preventive Management in Stroke Patients

Authors: News Author: Shelley Wood CME Author: Charles Vega, MD, FAAFPFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME Released: 8/9/2006; Reviewed and Renewed: 8/9/2007

Valid for credit through: 8/9/2008

processing....

August 9, 2006 -- Statin therapy should be initiated soon after stroke or transient ischemic attack (TIA) to reduce the risk not only of stroke, but also coronary events, even in patients with no prior cardiovascular disease (CVD), results from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial show. The findings, first reported by heartwire in May 2006 when they were presented at the 15th European Stroke Conference, are published in the August 10 issue of The New England Journal of Medicine.

With only a few months for the trial results to be absorbed by clinicians since the data were first unveiled, primary investigator for the study, K. Michael Welch, MB, ChB, FRCP, of the Rosalind Franklin University of Medicine and Science in Chicago, Illinois, said it is too soon to know what their impact will be. Already, however, "most of the vascular neurologists that I've talked to now believe that this will become an established part of the way patients are managed after they've had a stroke or a TIA in addition, of course, to the rigorous control of blood pressure, and the use of antiplatelet medications," Dr. Welch told heartwire .

SPARCL: Main Findings

SPARCL was the first trial to specifically look at the effect of a statin -- atorvastatin -- in patients with a prior stroke or TIA, but with no history of elevated cholesterol levels or coronary artery disease. The study randomly assigned 4731 patients with a stroke or TIA within the past 1 to 6 months to either 80 mg/day of atorvastatin or placebo. The mean baseline low-density lipoprotein cholesterol level in SPARCL participants was 133 mg/dL (2.6 - 4.9 mmol/L) but dropped to a mean level of 73 mg/dL (1.9 mmol/L) in the atorvastatin-treated patients during the trial, a 37% reduction. Low-density lipoprotein cholesterol levels decreased by 7% during the study for the mean 4.9-year follow-up.

This appeared to translate into a significant reduction in the primary end point of nonfatal or fatal stroke, which occurred in 11.2% of atorvastatin-treated patients and 13.1% of placebo-treated patients, a 5-year absolute reduction in risk of 2.2% and an adjusted hazard ratio of 0.84 (adjusted P value = .03). No significant differences were seen between the 2 groups in terms of adverse events. The treated group also showed significant reductions in fatal stroke, ischemic stroke, and a trend toward fewer nonfatal strokes, but a slight increase in hemorrhagic stroke, with a hazard ratio of 1.66. Given the lack of baseline CVD in the SPARCL cohort, risk for major coronary events was also significantly reduced in the atorvastatin-treated patients at a rate of 3.4% vs 5.1% ( P = .003).

"Certainly the cardiologists love this study," Dr. Welch told heartwire , "because for them it's actually a primary prevention study. Here we have patients who have no known cardiovascular disease who have had a stroke or TIA and there was a 35% reduction in heart disease, which is quite extraordinary. I think that, in practice, physicians will start to call for adding statins in folks who are admitted to hospital with a stroke or TIA as part of the established preventive management of these patients."

Hemorrhage Risk Should Be Considered

As noted in previous heartwire coverage of the SPARCL trial, the apparent increased risk for hemorrhagic stroke was included in the overall stroke analysis, suggesting a net benefit for statin use. Commenting on the issue, Dr. Welch emphasized that the increased hemorrhagic stroke in atorvastatin-treated patients while small (2.3% in the atorvastatin group vs 1.4% in the placebo group), has also been seen in other statin trials.

"It's a concern, enough for us to do further analyses to see if we can identify those patients who might be at risk so they can be managed in a different way," Dr. Welch told heartwire . "We will certainly look at those conditions like age, male gender, and blood pressure before the event, which are well known to be associated with a risk of hemorrhage into the brain, and we'll see if there's some kind of imbalance between the two groups that might have accounted for this."

At the same time, Dr. Welch cautioned, "The people who do have hemorrhage also are at risk for heart disease and stroke: they all have hypertension, they all have problems with their lipids and cholesterol, with obesity, etc, so they will need protection. And in the [SPARCL] study, the benefits in preventing stroke and heart disease -- which was remarkable since these folks had no known heart disease to start with -- those benefits far outweigh the small increased risk of hemorrhage."

In the article, the authors advise that the potential risk for recurrent hemorrhage "be considered when one is deciding whether to administer a statin to patients who have had a hemorrhagic stroke."

A Question of Timing

Dr. Welch also emphasized the "critical" importance of timing of statin treatment, noting that, in the Heart Protection Study, which also included patients with previous stroke or TIA but no established CVD, no benefit of statin treatment was seen in this group.

"If you have a stroke or a TIA your risk of having another one in the next five years is about 40%, but the HPS [Heart Protection Study] began to recruit patients about four years after their stroke or TIA. So our feeling was that it would have been [a] much tougher thing to show a difference when treating after four years, then within the first six months. And that's when you really want to treat these folks because the risk is so high within the next four years, not only for stroke, but for death."

Statins, Still Debatable, but Perhaps a Place to Start

In an editorial accompanying the SPARCL results, David M. Kent, MD, MS, of the Tufts--New England Medical Center in Boston, Massachusetts, observes that while the SPARCL results are "roughly consistent" with the stroke benefits seen in heart disease trials, questions about the link between cholesterol lowering and stroke prevention remain.

Stroke etiology is much more heterogeneous than myocardial infarction, Dr. Kent notes, and only a minority of strokes is caused by large-vessel atherothrombosis. Yet, SPARCL enrolled patients with not only ischemic strokes, but also hemorrhagic, embolic, lacunar, and cryptogenic strokes/TIAs, while patients with atrial fibrillation and other cardiac sources of emboli were excluded. Cardioembolic strokes are less likely than other types of ischemic stroke to be responsive to cholesterol-lowering agents, Dr. Kent points out.

"This raises the issue of whether the SPARCL results apply to the roughly one in five ischemic strokes that are cardioembolic in origin," Dr. Kent writs. "The heterogeneity of the patients enrolled in the trial, in terms of not only the cause of stroke but also vascular risk, is important to keep in mind in the interpretation of the results, since the rate of fatal or nonfatal stroke was relatively low and the absolute benefit of treatment with atorvastatin was relatively modest. A modest overall benefit across a heterogeneous population often obscures a more dramatic treatment effect in an influential subgroup among others that are highly unlikely to benefit."

Dr. Kent also points out that 20% of SPARCL participants had diabetes, and while Framingham risk scores were not provided in the article, extrapolating from event rates in the placebo-treated patients would suggest that the cohort as a whole likely had a 10-year coronary heart disease risk of roughly 10%. Thus, according to the Adult Treatment Panel III criteria for statin therapy, "even without any change in guidelines, it is apparent that many of the patients enrolled would already qualify for statin therapy," Dr. Kent writes.

All the same, Dr. Kent concludes, the SPARCL results will likely add to the mounting momentum behind adding ischemic stroke as a coronary heart disease risk equivalent and the inclusion of statins in stroke prevention guidelines and quality performance indicators.

"Those who might object to this collective-treatment approach to such a heterogeneous disease should be reminded of our abysmal performance as individual doctors taking care of individual patients. ... Although we can all agree with the calls for careful science, and although we await the various SPARCL substudies to help clarify some controversies, it does not take recursive subgroup analyses to show that the greatest current risk to patients with ischemic stroke vis-à-vis statins remains gross undertreatment."

N Engl J Med. 2006;355:549-559.

The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.