Discontinuation of aspirin at 90 days following stenting and continuing on P2Y12 inhibitor monotherapy, was not associated with increased rates of death from any cause, heart attack, or stroke after one year, according to a new study presented at the American College of Cardiology Annual Scientific Sessions in New Orleans.
Researchers for the SMART-CHOICE trial enrolled 2,993 patients who underwent percutaneous coronary intervention (PCI) and received a cobalt chromium everolimus-eluting eluting stent. Patients were randomly assigned to receive either standard dual antiplatelet therapy (DAPT) or aspirin plus a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor) for the first three months and then just the P2Y12 inhibitor by itself for the remaining nine months. The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE; all-cause death, myocardial infarction, or stoke at 12 months after index procedure).
According to the study results, there was no difference in the primary study endpoint of MACCE rate (2.9% P2Y12 inhibitor vs. 2.5% DAPT; HR=1.19; 95% CI, 0.76 to 1.85; P-0.46; P=0.007 for noninferiority). There was no observed difference between the study groups at 90 days (HR=1.31; 95% CI, 0.57 to 2.98; P=0.52) and at one year (HR=1.14; 95% CI, 0.67 to 1.93; P=0.63). There was a small advantage for patients assigned to P2Y12 inhibitor monotherapy at one year in terms of BARC type 2-5 bleeding (P=0.02), with a similar finding in the per protocol analysis (P=0.04).
Study limitations included the wide noninferiority margin, lower-than-expected event rates, the open-label design (ie, no placebo control), and also the large portion of patients in the P2Y12 group did end up receiving aspirin after three months.
“Our study demonstrated that P2Y12 inhibitor monotherapy after a short duration of DAPT is a novel antiplatelet strategy balancing ischemic and bleeding risk in patients undergoing PCI,” said lead author Joo-Yong Hahn, MD, PhD, a professor of medicine at Sungkyunkwan University School of Medicine in Seoul, South Korea, in a press release. “Even though this treatment strategy needs to be confirmed in other trials, aspirin may be discontinued in most patients receiving current-generation drug-eluting stents, especially in patients with bleeding risk or in those with stable ischemic heart disease.”
Dr. Hahn added that comparisons with other trials can help to clarify the role of P2Y12 inhibition monotherapy.
“The SMART-CHOICE trial has a unique design to include all kinds of P2Y12inhibitors,including clopidogrel, prasugrel and ticagrelor,” Hahn said. “Therefore, we believe that the SMART-CHOICE trial, compared with several ongoing trials on P2Y12inhibitor monotherapy after PCI, provides more generalizable answers to the concept of P2Y12inhibitor monotherapy across a broad spectrum of patients receiving current-generation drug-eluting stents.”
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