ProFESS gives new direction for selection of antiplatelet therapies for stroke patients

Susan C. Fagan, Pharm.D., BCPS, FCCP
November, 2008

Although the results of noncomparative clinical trials led experts in the stroke field to prefer the combination of aspirin and extended release dipyridamole (ERDP) over clopidogrel or aspirin for secondary prevention of noncardioembolic stroke, all three agents were first line in recent guidelines.¹ Anticipation was high that the ProFESS trial, comparing clopidogrel and the combination of aspirin and ERDP for prevention of recurrent stroke, would be the definitive answer to the selection process.

ProFESS was the largest stroke trial ever performed with more than 20,000 patients enrolled in 35 different countries.² Using a 2x2 factorial design, the investigators compared the two antiplatelet agents and an angiotensin receptor blocker (ARB) (telmisartan) to placebo. To everyone’s surprise, there were absolutely no differences in recurrent stroke rates between the treatments (9% over 2.5 years). Even in the ARB arm, where prior publications suggested that ARBs would provide vascular protection, there was no difference. Also, even though some expected a lower bleeding rate in the aspirin/ERDP group, this was not the case - clopidogrel was at least as safe.

The bottom line of the ProFESS trial, was that clopidogrel and aspirin/ERDP are not different in their efficacy and both agents are safe. As a result of this trial, we will probably see a resurgence in the use of clopidogrel (without aspirin) as a secondary prevention strategy in ischemic stroke patients.

References

• Adams RJ et al. Update to the AHA/ASA recommendations for the prevention of stroke in patients with stroke and transient ischemic attack. Stroke. 2008 May;39(5):1647-52.
• Sacco RL et al. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51.