Scientific Publications by FDA Staff

Am Heart J 2013 Mar;165(3):344-353

TransRadial Education And Therapeutics (TREAT): Shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: A report from the Cardiac Safety Research Consortium.

Hess CN, Rao SV, Kong DF, Miller JM, Anstrom KJ, Bertrand OF, Collet JP, Effron MB, Eloff BC, Fadiran EO, Farb A, Gilchrist IC, Holmes DR, Jacobs AK, Kaul P, Newby LK, Rutledge DR, Tavris DR, Tsai TT, White RM, Peterson ED, Krucoff MW

Percutaneous coronary intervention (PCI) is an integral part of the treatment of coronary artery disease. The most common complication of PCI, bleeding, typically occurs at the vascular access site and is associated with short-term and long-term morbidity and mortality. Periprocedural bleeding also represents the primary safety concern of concomitant antithrombotic therapies essential for PCI success. Use of radial access for PCI reduces procedural bleeding and hence may change the risk profile and net clinical benefit of these drugs. This new drug-device safety interaction creates opportunities to advance the safe and effective use of antithrombotic agents during PCI. In June 2010 and March 2011, leaders from government, academia, professional societies, device manufacturing, and pharmaceutical industries convened for 2 think tank meetings. Titled TREAT I and II, these forums examined approaches to improve the overall safety of PCI by optimizing strategies for antithrombotic drug use and radial artery access. This article summarizes the content and proceedings of these sessions.