The challenge for physicians is that anticoagulants used for PCI often increase the risk of bleeding, especially at femoral access points in the thigh. A multi-site study led by a Miller School cardiologist has provided the first clinical application of a unique drug system that consists of an anticoagulant which thins the blood, and a control agent which then quickly reverses the process after the intervention.
Mauricio G. Cohen, M.D., associate professor of medicine in the Cardiovascular Division, led the Phase IIa study which he calls “an important milestone in the search for safer anticoagulants for patients undergoing procedures in the catheterization lab.” The study results are published in the July 26 online issue of Circulation, a journal of the American Heart Association.
The study represented the first clinical application of REG1, a unique RNA drug system made up of an anticoagulant/blood thinner (RB006) and a control agent (RB007) to reverse anticoagulation. The REG1 system, developed by Regado Biosciences, Inc., is the first of its kind to enter clinical testing. This Phase IIa, multi-site randomized study compared REG1 with unfractionated heparin during angioplasty.
The 26-patient trial was conducted between October 2007 and October 2008, at four U.S. sites and one in Argentina. The study indicated the use of the anticoagulant (RB006) provided a rapid and measurable response in patients. The control agent of REG1, RB007, which reverses the anticoagulation effect, was then used to control the stepdown process. Cohen says the product can be administered according to the specific needs of the patient.
“Our results are encouraging because none of the procedures were complicated with clots in the catheters or guidewires, a complication observed with other novel anticoagulants recently tested in clinical trials.”
Additionally, the study demonstrated that the anticoagulant effect of RB006 and the reversal activity of RB007 can be measured accurately at the patient’s bedside, providing physicians with more information, making the REG1 system applicable in clinical practice. The ability to more quickly return coagulation function using the control agent also facilitates the early removal of the femoral arterial sheath.
Mauro Moscucci, M.D., M.B.A., professor and vice chair of medicine and chief of the Cardiovascular Division, says Cohen’s study has significant practical implications. Interventional cardiologists need improved methods to anticoagulate patients undergoing percutaneous coronary procedures. “This study points to what could be a major breakthrough in this field.”
Cohen says the REG1 system needs to be tested in larger studies to confirm these results, and ongoing trials will provide more insight about its safety and efficacy. “We’re very excited about the application of an anticoagulant that can be controlled and monitored in patients undergoing stenting procedures.”