News | Antiplatelet and Anticoagulation Therapies | February 13, 2018

Abbott Begins Enrollment in XIENCE 28 GLOBAL DAPT Trial

XIENCE 28 Study will evaluate whether patients at high risk of bleeding can safely receive blood thinners for as short as 28 days after receiving drug-eluting stent

Abbott Begins Enrollment in XIENCE 28 GLOBAL DAPT Trial

February 13, 2018 — Abbott announced the first patient has been enrolled in a clinical trial evaluating 28 days of dual antiplatelet therapy (DAPT) in patients at high risk of bleeding after implantation with a Xience everolimus-eluting coronary stent. The first patient was enrolled into the  XIENCE 28 GLOBAL DAPT study by Prof. Emanuele Barbato, M.D., Ph.D., a cardiologist at OLV-Hospital Aalst in Belgium.

Patients who receive a stent are generally prescribed blood-thinning medicines to reduce the risk of stent thrombosis. However, blood thinning medicines can increase the risk of bleeding for some patients due to factors such as older age, chronic use of anticoagulant medications, anemia and renal disease[1],[2].

"While blood thinning medicines are important to prevent clots after a stent is implanted, we want to limit the duration of these medications for people who are at high risk of bleeding," said Marco Valgimigli, M.D., Ph.D., associate professor of cardiology and senior interventional cardiologist at the Universitätsspital in Bern, Switzerland, and co-principal investigator of the study. "This trial will help determine if high-bleeding risk patients can safely reduce their duration of blood thinning medication to as short as 28 days."

In Europe, most patients at high risk of bleeding are currently treated with DAPT for three to six months after receiving a drug-eluting stent, according to EU treatment guidelines.[3]

XIENCE 28 GLOBAL is a prospective, single-arm, multi-center, open label, non-randomized study. The goal of the study is to assess whether one month of treatment with DAPT is non-inferior to at least six months of DAPT in high-bleeding risk patients. The primary endpoint is a composite rate of myocardial infarction, stent thrombosis, death, stroke or major bleeding between one and six months. Approximately 800 patients will be enrolled at 50 sites across Europe and Asia.

For more information: www.xiencestent.com/featured-trials

 

Related DAPT Content

Six Months of DAPT Non-Inferior to Twelve in STEMI Patients Receiving Drug-Eluting Stents

Synergy Stent With Shorter DAPT Superior to Bare-Metal Stent in Elderly Patients

Three-Month DAPT Non-Inferior for ACS Patients Treated With Combo Dual Therapy Stent

Key Interventional Cardiac Technology Updates to Prepare for TCT 2017

Questions Remain on DAPT Prolongation

 

References

1. Shanmugam VB, Harper R, Meredith I, Malaiapan Y, Psaltis PJ. An overview of PCI in the very elderly. J Geriatr Cardiol 2015;174−184.

2. Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006;114:774–82.

3. Valgimigli M, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur Heart J. 2017 Aug 26. doi: 10.1093/eurheartj/ehx419.

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