Evaluation of the PAS-Port Proximal Anastomosis System in coronary artery bypass surgery (the EPIC trial) (original) (raw)

2009, The Journal of Thoracic and Cardiovascular Surgery

Objective: During coronary surgery, proximal vein graft anastomoses have been performed by using an aortic partial occlusion clamp to allow for a hand-sewn anastomosis. The purpose of this multicenter, prospective, randomized trial was to evaluate the efficacy of the PAS-Port device (Cardica, Inc, Redwood City, Calif), which allows an automated proximal anastomosis to be performed without aortic clamping. Between June 22, 2006, and March 22, 2007, 220 patients requiring coronary artery bypass grafting with at least 2 vein grafts were enrolled. Within each patient, 1 graft was randomly assigned to receive a PAS-Port device, and the other was assigned to receive a hand-sewn anastomosis to the ascending aorta. The primary end point was angiographic patency (<50% stenosis) 9 months after surgical intervention. Secondary end points included average time to complete each anastomosis and 9-month freedom from major adverse cardiac events.

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