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TARDIS: Intensive antiplatelet regimen not superior to guideline therapy for prevention of recurrent stroke, TIA

Issue: April 2017

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Triple antiplatelet therapy for preventing recurrent stroke in patients with acute ischemic stroke or transient ischemic attack was not more effective than guideline-recommended dual antiplatelet therapy, according to the results of the TARDIS trial.

“Basically, it looks like you're getting extra bang for your buck by having two drugs, but as soon as you get up to three, the net benefit disappears," Philip M. Bath, MD, MBBS, FRCP, Stroke Association Professor of Stroke Medicine and head of the division of clinical neuroscience, faculty of medicine and health sciences, University of Nottingham, Nottingham, United Kingdom, said during a presentation at the International Stroke Conference. "You certainly don't want to go to four, because the bleeding risk would then be really bad."

The 3,096-patient TARDIS trial was a prospective, randomized, open-label, blinded-endpoint trial that took place between April 2009 and March 2016 at 106 sites in four countries.

Patients (mean age, 69 years; 63% men; 11% with prior stroke) were randomly assigned to either intensive antiplatelet therapy consisting of aspirin, clopidogrel and dipyridamole or a guideline-directed antiplatelet regimen of clopidogrel alone or a combination of aspirin and dipyridamole taken for 1 month.

The primary outcome was recurrence of stroke and TIA and their severity at 3 months, as measured by the modified Rankin Scale.

In March 2016, the trial was stopped early at the recommendation of the Independent Data Monitoring Committee, as definitive results had already been reached, Bath said.

The index event was ischemic stroke in 71.7% of patients and TIA in the remainder.

There was no significant difference between the groups in the primary outcome (adjusted composite OR = 0.93; 95% CI, 0.7-1.23) or in fatal stroke (adjusted OR = 1.62; 95% CI, 0.67-3.93), Bath and colleagues found.

For the primary outcome, triple therapy was superior in those with NIH Stroke Scale score 3 but inferior in those with a score of more than 3; and it was superior compared with the aspirin/dipyridamole but inferior to clopidogrel alone, Bath said.

Compared with guideline-directed therapy, triple therapy was associated with increased bleeding (adjusted composite OR = 2.49; 95% CI, 2-3.1) and major bleeding (adjusted HR = 2.04; 95% CI, 1.16-3.6). There was no significant difference in fatal bleeding (adjusted HR = 2.32; 95% CI, 0.64-8.36).

“We cannot recommend taking intensive antiplatelets and we should stick to current guidelines,” Bath said during the presentation. – by Dave Quaile

Reference:

Bath PM, et al. LB4. Presented at: International Stroke Conference; Feb. 22-24, 2017; Houston.

Disclosure: Bath reports no relevant financial disclosures.