Abbott (NYSE:ABT) said today that it enrolled the first patient in a trial evaluating the short-term use of blood thinning drugs, called dual antiplatelet therapy, after implantation of the company’s Xience everolimus-eluting coronary stent.
The 2,000-patient study is slated to assess if three months of DAPT is non-inferior to the current standard of 12 months for patients at high risk of bleeding.
Traditionally, blood thinners are prescribed for patients after stent implantation to prevent stent thrombosis. But these medications can increase the risk of bleeding complications.
“Limiting the duration of blood thinning medicine from 12 months to three months is particularly important for people at higher risk of bleeding due to factors such as older age, anemia, and renal disease,” principal investigator Dr. Roxana Mehran said in prepared remarks. “The results of this study will help determine if doctors can safely reduce the amount of time that high bleeding-risk patients must take blood thinning medication after receiving a Xience stent to unblock coronary arteries.”
The study’s primary endpoint is non-inferior rates of myocardial infarction or death in patients with high risk of bleeding. Secondary endpoints are evaluation of the extent and severity of bleeding rates, stent thrombosis, stroke, revascularization, myocardial infarction and death, Abbott reported.
The Xience drug-eluting stent was approved by the FDA in 2008.
“Since its initial regulatory approval, Xience has been implanted in approximately 10 million people, and is considered the safest drug eluting stent available,” Dr. Charles Simonton, chief medical officer & divisional VP of medical affairs for Abbott’s vascular biz, added. “We continue to advance Xience research with the goal of helping even more people return to their daily lives as quickly as possible.”