Abbott has unveiled new data from two clinical studies in its XIENCE Short DAPT programme, which showed that short-term treatment using dual antiplatelet therapy (DAPT) was effective for patients at elevated risk of bleeding.
Usually, DAPT is prescribed for patients who undergone coronary stent implantation, to prevent thrombosis (blood clotting), which may block blood vessels and could cause heart attack.
However, treatment using DAPT is often associated with increased risk of bleeding complications in few patients.
The new clinical data showed no rise in ischemic events when DAPT delivered for shorter durations to patients who require stenting, but may adversely respond to blood-thinning medications.
Abbott Short DAPT programme global principal investigator Roxana Mehran said: “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.
“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.”
Abbott’s XIENCE Short DAPT programme includes XIENCE 28 and XIENCE 90 trials
The new clinical data includes XIENCE 28 trial in 1,605 patients and XIENCE 90 trial in 2,047 patients, from the company’s XIENCE Short DAPT programme.
The XIENCE 28 study assessed the treatment using DAPT, either for 28 days or 6 months, in patients who undergone XIENCE implantation, and at high risk of bleeding.
The study met the endpoint of non-inferiority of all-cause death or myocardial infarction (MI) from 1 to 6 months, in patients who received 28 days of DAPT, compared to patients who received DAPT for 6 months.
The study showed that treatment using DAPT for 28 days was equally effective as treatment using DAPT for 6 months, after implantation with a XIENCE stent.
Also, patients who received DAPT therapy for 28 days have experienced reduced severe bleeding (BARC 3-5) than patients who received the therapy for 6 months.
The XIENCE 90 study evaluated the same patient population as the XIENCE 28 study but compared results against 12 months of DAPT.
The primary endpoint was non-inferiority of all-cause death or all MI from 3 to 12 months after XIENCE implantation.
In the XIENCE 90 trial, high bleeding risk patients experienced reduced risk of a blood clot in the stented area and severe bleeding after DAPT treatment for 12 months, compared to 90 days DAPT treatment.
Abbott vascular business chief medical officer and medical affairs divisional vice president Nick West said: “Since the initial launch more than ten years ago, the XIENCE family of stents has become the gold-standard in coronary drug-eluting stents.
“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.”
