ITALIC: Is Six Month DAT Post Coronary Stenting Non Inferior to 24 Month?
Despite previous recommendations suggesting that the duration of dual antiplatelet therapy (DAT) in drug-eluting stent (DES) patients not exceed 12 months, a new study has shown that there is no difference in rates of bleeding and thrombotic events between six and 24 month DAT in new generation DES patients.
The ITALIC trial, presented Nov. 16 at AHA 2014 and simultaneously published in the Journal of the American College of Cardiology, was led by Martine Gilard, MD, PhD, and sought to assess the effect of short and long term DAT after coronary intervention on patients who received new generation DES and were also non-resistant to aspirin. After aspirin monitoring, 131 patients were classified as aspirin resistant, and were not randomized but followed up in the aspirin-resistant group. Of the 1,850 patients that were non-resistant to aspirin, 926 were randomized to receive six month DAT, while 924 patients randomly received 24 month.
Both treatment groups had similar baseline and procedural characteristics. One-third of patients had a history of type-2 diabetes, one fourth had a previous percutaneous coronary intervention or bypass surgery, and almost half presented with acute coronary syndrome (ACS). The primary endpoints in the study were death, myocardial infarction (MI), repeat emergency target vessel revascularization (TVR), stroke or major bleeding at 12 months post-stenting. No significant difference between the treatment groups existed regarding the primary endpoint (1.5 vs. 1.6 percent, p=0.85), even in the patients with ACS.
The trial demonstrated the existence of non-inferiority for six month vs. 24 month DAT, with an absolute risk difference of 0.11 percent (p for non-inferiority= 0.0002). Furthermore, no significant differences in stent thrombosis and bleeding complications were revealed.
The trial also did not show an increase in bleeding in the long term DAT patients, but rather that the longer DAT reduced the composite end points of death, stroke and MI. The authors note that moving forward, “longer trials are needed to assess the effect of antiplatelet duration in ACS patients.”
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