Abbott expands U.S. Xience V trial, to enroll patient in DAPT trial
Abbott has expanded its XIENCE V USA post-approval study designed to evaluate the safety and effectiveness of its Xience V everolimus-eluting coronary stent in a real-world clinical setting out to five years. The expansion allows for more than 2,000 patients from the XIENCE V trial to cross over into the Dual Anti-Platelet Therapy (DAPT) Trial.
The first patient was enrolled into the XIENCE V USA expansion by James Hermiller, MD, director of cardiac cath labs at the Care Group at St. Vincent Hospital in Indianapolis. Hermiller is a principal investigator of the XIENCE V USA trial along with Mitch Krucoff, MD, director of the cardiovascular devices unit at Duke Clinical Research Institute in Durham, N.C.
The XIENCE V USA trial expansion allows for an additional 3,000 patients to be enrolled into Abbott's study, which was originally designed to study 5,000 patients in the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC).
The DAPT trial is an independent study with about 20,000 patients. The trial is intended to determine the appropriate duration for DAPT, as well as the safety and effectiveness of DAPT to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events following the implantation of either a drug-eluting stent or bare-metal stent.
The DAPT trial was developed by a consortium of eight companies (four stent manufacturers—Abbott, Medtronic, Boston Scientific and Cordis—and drugmakers of antiplatelet medications—Bristol-Myers Squibb, Sanofi Aventis, Eli Lilly and Daiichi Sankyo) who came together to address an FDA request for this post-market study. The Harvard Clinical Research Institute is responsible for the design, conduct and analysis of the study.
The first patient was enrolled into the XIENCE V USA expansion by James Hermiller, MD, director of cardiac cath labs at the Care Group at St. Vincent Hospital in Indianapolis. Hermiller is a principal investigator of the XIENCE V USA trial along with Mitch Krucoff, MD, director of the cardiovascular devices unit at Duke Clinical Research Institute in Durham, N.C.
The XIENCE V USA trial expansion allows for an additional 3,000 patients to be enrolled into Abbott's study, which was originally designed to study 5,000 patients in the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC).
The DAPT trial is an independent study with about 20,000 patients. The trial is intended to determine the appropriate duration for DAPT, as well as the safety and effectiveness of DAPT to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events following the implantation of either a drug-eluting stent or bare-metal stent.
The DAPT trial was developed by a consortium of eight companies (four stent manufacturers—Abbott, Medtronic, Boston Scientific and Cordis—and drugmakers of antiplatelet medications—Bristol-Myers Squibb, Sanofi Aventis, Eli Lilly and Daiichi Sankyo) who came together to address an FDA request for this post-market study. The Harvard Clinical Research Institute is responsible for the design, conduct and analysis of the study.