DAPT trial expands into Europe
The DAPT [Dual-AntiPlatelet Therapy] trial has expanded into seven countries in the European Union, according to the Harvard Clinical Research Institute.
John Irving, MD, a consultant cardiologist at Ninewells Hospital in Dundee, U.K., was the first European investigator to enroll patients into the study. Enrollment is opening at multiple centers across the EU and will include participation in the following countries: the Czech Republic, France, Germany, Hungary, Poland, Romania and the U.K. Enrollment into the DAPT Study was initiated in the U.S. in October 2009.
The four-year clinical trial is investigating the duration of DAPT (the combination of aspirin and a thienopyridine/antiplatelet medication) following drug-eluting stent (DES) implantations. The large-scale public health study is expected to bring clarity regarding the benefits of 12 versus 30 months of dual antiplatelet therapy in patients receiving DES to address coronary artery lesions.
The European Society of Cardiology currently recommends three to four weeks of DAPT for patients undergoing PCI with bare-metal stent placement and six to12 months of DAPT following DES placement. The American College of Cardiology and American Heart Association currently recommend 12 months of dual-antiplatelet therapy after placement of a DES.
The study’s Principal Investigator Laura Mauri, MD, an interventional cardiologist at the Brigham and Women's Hospital and Harvard Medical School in Boston, and chief scientific officer of Harvard Clinical Research Institute, said: “The lack of definitive data regarding the risks versus benefits of continuing dual-antiplatelet therapy beyond one year to prevent stent thrombosis remains a critical issue that has caused uncertainty in the global cardiology community. The expansion of the DAPT Study into the EU is an important milestone in support of our goal of enrolling over 20,000 subjects and obtaining a diversity of data that reflects real-world clinical practice.”
"The DAPT Study addresses a critical gap in current scientific evidence," said Philippe Gabriel Steg, MD, DAPT national coordinator for France, DAPT and an interventional cardiologist at Hopital Bichat in Paris.
The DAPT Study is being conducted through a public-private collaboration involving HCRI; four major stent manufacturers: Abbott (Xience V), Boston Scientific (Taxus, Promus), Cordis (Cypher) and Medtronic (Endeavor); along with the makers of thienopyridine/antiplatelet medications: Bristol-Myers Squibb/Sanofi-Aventis (Plavix [clopidogrel]) and Eli Lilly and Daiichi Sankyo (Effient/Efient [prasugrel]); and the FDA.
The HCRI, which is responsible for the scientific management of the DAPT Study and the independent analysis of the resulting data, received funding support from each of the drug and device manufacturers.
John Irving, MD, a consultant cardiologist at Ninewells Hospital in Dundee, U.K., was the first European investigator to enroll patients into the study. Enrollment is opening at multiple centers across the EU and will include participation in the following countries: the Czech Republic, France, Germany, Hungary, Poland, Romania and the U.K. Enrollment into the DAPT Study was initiated in the U.S. in October 2009.
The four-year clinical trial is investigating the duration of DAPT (the combination of aspirin and a thienopyridine/antiplatelet medication) following drug-eluting stent (DES) implantations. The large-scale public health study is expected to bring clarity regarding the benefits of 12 versus 30 months of dual antiplatelet therapy in patients receiving DES to address coronary artery lesions.
The European Society of Cardiology currently recommends three to four weeks of DAPT for patients undergoing PCI with bare-metal stent placement and six to12 months of DAPT following DES placement. The American College of Cardiology and American Heart Association currently recommend 12 months of dual-antiplatelet therapy after placement of a DES.
The study’s Principal Investigator Laura Mauri, MD, an interventional cardiologist at the Brigham and Women's Hospital and Harvard Medical School in Boston, and chief scientific officer of Harvard Clinical Research Institute, said: “The lack of definitive data regarding the risks versus benefits of continuing dual-antiplatelet therapy beyond one year to prevent stent thrombosis remains a critical issue that has caused uncertainty in the global cardiology community. The expansion of the DAPT Study into the EU is an important milestone in support of our goal of enrolling over 20,000 subjects and obtaining a diversity of data that reflects real-world clinical practice.”
"The DAPT Study addresses a critical gap in current scientific evidence," said Philippe Gabriel Steg, MD, DAPT national coordinator for France, DAPT and an interventional cardiologist at Hopital Bichat in Paris.
The DAPT Study is being conducted through a public-private collaboration involving HCRI; four major stent manufacturers: Abbott (Xience V), Boston Scientific (Taxus, Promus), Cordis (Cypher) and Medtronic (Endeavor); along with the makers of thienopyridine/antiplatelet medications: Bristol-Myers Squibb/Sanofi-Aventis (Plavix [clopidogrel]) and Eli Lilly and Daiichi Sankyo (Effient/Efient [prasugrel]); and the FDA.
The HCRI, which is responsible for the scientific management of the DAPT Study and the independent analysis of the resulting data, received funding support from each of the drug and device manufacturers.