A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding.
Abbott presented the late-breaking data today at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation. Late-breaking results from the Short DAPT program of clinical trials evaluated findings from both the XIENCE 28 (1,605 patients) and XIENCE 90 (2,047 patients) studies.
DAPT is routinely prescribed after coronary stent implantation to help prevent clotting, but DAPT can also increase the risk of bleeding complications in some patients. The new late-breaking Short DAPT data showed no increase in ischemic events with shorter durations of DAPT for patients who require stenting, but who may adversely respond to blood-thinning medications.
“New approaches for managing patients at high risk of bleeding after stent implantation is an important area of study, and this data around shorter durations of antiplatelet therapy offer a strong view into alternatives for these patients,” said Dr. Roxana Mehran, global principal investigator for Abbott’s Short DAPT program (XIENCE 28 and XIENCE 90), in a news release.
“We are encouraged by these results as they could reduce patient exposure to medications like blood thinners and provide the cardiovascular community with critical information on how it approaches the use of DAPT for at-risk patients who receive coronary stenting, ” added Mehran, who is also director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai.
The XIENCE 28 study
Physicians assessed a primary endpoint of non-inferiority comparing rates of all-cause death or myocardial infarction (MI) following Xience implantation in high bleeding-risk patients who received either 28 days or 6 months of DAPT. Findings include:
- Treatment with DAPT for 28 days was found to be the same as treatment with 6 months of DAPT after implantation with a Xience stent.
- The study met the endpoint of non-inferiority of all-cause death or MI from 1 to 6 months, with an overall death or MI rate of 3.5% in patients who received 28 days of DAPT compared with 4.3% in patients who received 6 months of DAPT (p=0.0005).
- Severe bleeding (BARC 3-5) was found to be significantly lower in patients who received 28 days of DAPT (2.2%) compared with 6 months of DAPT (4.5%; p=0.02).
The XIENCE 90 study
The XIENCE 90 study investigated the non-inferiority of all-cause death or all MI from 3 to 12 months following Xience implantation in the same patient population as the XIENCE 28 study but compared results against 12 months of DAPT. Findings include:
- From 3 to 12 months, the risk of a blood clot in the stented area was as low as in patients who received 12 months of DAPT.
- Severe bleeding was significantly lower for high bleeding-risk patients (2.2% for the 90-day DAPT group compared with 6.3% for the 12-month DAPT group).
Abbott launched Xience DES more than ten years ago.
“With the Short DAPT program, our goal is ultimately to find the optimal duration of use of blood-thinning medication for individual patients by providing tailored treatment options to minimize the risk of potentially fatal bleeding events and to help them return to their daily lives as quickly as possible,” said Dr. Nick West, divisional VP of medical affairs, and chief medical officer in Abbott’s vascular business.
