Abbott has reported late-breaking data from two trials in its XIENCE Short dual antiplatelet therapy (DAPT) programme.
The XIENCE 28 and XIENCE 90 trials showed equal outcome with shorter courses of DAPT in minimising the frequency of post-stenting death versus 12 months of DAPT, following implantation of XIENCE drug-eluting stent in patients with high bleeding risk.
DAPT is routinely prescribed after coronary stent implantation to help prevent clotting that can result in a heart attack or death.
However, DAPT can fuel the risk of bleeding complications in one out of five patients. The XIENCE 28 trial analysed non-inferiority comparing rates of all-cause death or myocardial infarction (MI), following XIENCE implantation as the primary endpoint.
It was conducted on 1,605 patients with high bleeding risk. They received either 28 days or six months of DAPT.
In patients who received 28 days of DAPT, overall death or MI rate was at 3.5% as compared to 4.3% in the six-month DAPT group, meeting the primary endpoint.
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Severe bleeding was significantly lower in patients who received 28 days of DAPT compared with those who received it for six months.
The XIENCE 90 trial was conducted on 2,047 patients and assessed the non-inferiority of all-cause death or all MI from three to 12 months, following XIENCE implantation.
The risk of a blood clot from three to 12 months in the stented area was as low as patients who received 12 months of DAPT.
Severe bleeding was significantly lower in the 90-day DAPT group versus the 12-month group.
Final data showed no increase in ischemic events with shorter durations of DAPT for patients who require stenting but do not respond well to blood-thinners.
Abbott vascular business chief medical officer and medical affairs divisional vice-president Nick West said: “With the Short DAPT programme, our goal is ultimately to find the optimal duration of use of blood-thinning medication for individual patients by providing tailored treatment options to minimise the risk of potentially fatal bleeding events and to help them return to their daily lives as quickly as possible.”
In 2018, the Food and Drug Administration (FDA) granted approval to Abbott’s next-generation XIENCE Sierra everolimus-eluting coronary stent system.