Findings show noninferiority for six-months of treatment in aspirin-sensitive patients
WEDNESDAY, Feb. 25, 2015 (HealthDay News) — For aspirin-sensitive patients undergoing everolimus-eluting stent implantation, six-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT, according to a study published in the March 3 issue of the Journal of the American College of Cardiology.
Martine Gilard, M.D., Ph.D., from Brest University in France, and colleagues examined whether antiplatelet treatment with DAPT for six months was noninferior to 24-month DAPT in patients who were aspirin sensitive. Patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin were randomized to receive six- or 24-month DAPT. Due to recruitment problems, the trial was terminated prematurely, with 941 patients randomized to 24-month DAPT and 953 to six-month DAPT.
The researchers found that at 12 months post-stenting, there was no significant between-group difference in the primary end point (composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding; 1.5 percent [24-month] versus 1.6 percent [six-month]; P = 0.85). Noninferiority was demonstrated for six-month DAPT, with an absolute risk difference of 0.11 percent (P for noninferiority = 0.0002). No significant differences were seen in stent thrombosis or bleeding complications. Primary and secondary end points did not differ for the 792 high-risk patients with acute coronary syndrome (hazard ratio, 1.7; 95 percent confidence interval, 0.519 to 6.057; P = 0361).
“Rates of bleeding and thrombotic events were not significantly different according to six- versus 24-month DAPT after percutaneous coronary intervention with new-generation drug-eluting stents in good aspirin responders,” the authors write.
The study was partially funded by Abbott Vascular Devices.
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