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Confirmation of the benefit of aspirin plus dipyidamole versus aspirin alone for secondary stroke prevention
Susan C. Fagan, Pharm.D., BCPS, FCCP
Study: The ESPRIT Study Group. Aspirin plus dipyidamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomized controlled trial. Lancet. 2006 May 20;367(9523):1665-73.
Antiplatelet therapy is recommended for all patients with a history of noncardioembolic ischemic stroke and TIA to reduce the risk of recurrence (1,2). One of three regimens are recommended as first line and they include: aspirin 50 – 325 mg daily, clopidogrel 75 mg daily or extended release dipyridamole 200 mg + aspirin 25 mg twice daily (1,2). Although the combination of aspirin and dipyridamole is generally thought to be superior to the other choices in two sets of published guidelines (1,2), it is mostly based on extrapolation and evidence from one large clinical trial (ESPS-2) until now (3).
In the ESPRIT trial, approximately 2800 TIA patients were randomized to receive either aspirin alone (n=1376) or the combination (n=1363) within 6 months of either a TIA or minor ischemic stroke and were followed for a mean of 3.5 years. It was an open label study. The primary outcome measure was a composite of vascular death, stroke, MI or major bleeding and the incidence was reduced significantly by the combination (16% vs. 13%), confirming the results of the ESPS-2 study. There was a trend towards a significant reduction in recurrent ischemic stroke, but this was not quite significant. Also, as in the ESPS-2 study, a high number of patients (34%) discontinued the combination treatment (compared to 13% in the aspirin alone group) and the most common reason (26%) was headache. Interestingly, the incidence of major bleeding events was lower in the combination group (n=35) than in the aspirin alone group (n=53) and it could not be explained by differences in aspirin doses.
Although the ESPRIT study is mainly confirmatory of that previously known about the aspirin/ dipyridamole combination for stroke prevention, we have learned some new information that may be important. In ESPRIT, the combination used did not include a fixed dose of aspirin and, in fact, only 8% actually used 50 mg daily as in ESPS-2. Most patients were on between 40 and 100 mg daily, however, but the dose of aspirin did not seem to determine outcome. Since the 200 mg of extended-release dipyidamole (83% of patients in ESPRIT were on this better tolerated and available form) is only available as the combination product in the United States, it is still prudent to use the combination rather than prescribing the two agents separately.
Sacco RL, Adams R, Albers G, Alberts MJ, Benevente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnson SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: A statement for health care professionals from the American Heart Association/ American Stroke Association Council on Stroke: Co-sponsored by the Council of Cardiovascular Radiology and intervention: The American Academy affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617.
Albers GW, Amarenco P, Easton JD, Sacco RL, Teal P. Antithrombotic and thrombolytic therapy for ischemic stroke. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):483S-512S.
Diener HC, Cunha I, Forbes C, Sivenius J, Smets P, Lowenthal A. European Stroke Prevention Study 2: dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci. 1996 Nov;143(1-2):1-13.
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