A multicenter prospective randomized trial of a second-generation anastomotic device in coronary artery bypass surgery.

OBJECTIVE: Our objective was to perform a prospective randomized trial to evaluate the clinical and angiographic outcomes of a second-generation anastomotic device used for saphenous vein grafts. METHODS: Patients undergoing nonemergency isolated coronary artery bypass grafting at 3 centers from August 2003 to December 2004 with at least 2 saphenous vein grafts were included. The proximal anastomoses were randomized, within each patient, to be constructed by the connector or by suture. One-year graft patency was evaluated by coronary angiography, magnetic resonance imaging, or computed tomography and analyzed on an intent-to-treat basis. RESULTS: A total of 151 patients (65 +/- 9 years, 87% male) who met inclusion/exclusion criteria were enrolled in the study and were analyzed. A total of 489 grafts were constructed (3.2 +/- 0.5 grafts per patient), including 327 vein grafts randomized to the connector (n = 162) or suture (n = 165). In 162 connector grafts, 151 devices were successfully implanted. Technical issues required explantation of 11 devices intraoperatively. Patency was evaluated in 120 (81%) patients with 260 study grafts. Seventy-four patients with 161 grafts were evaluated by coronary angiography, 31 patients with 69 grafts by magnetic resonance imaging, and 15 patients with 30 grafts by computed tomography. The 1-year patency rate for study grafts constructed with the anastomotic connector was 92.2% (118/128) and for hand-sutured grafts, 91.7% (121/132). CONCLUSIONS: This prospective multicenter randomized controlled trial demonstrated good in-hospital and late clinical outcomes and excellent 1-year patency for vein grafts anastomosed both by the St Jude Medical second-generation aortic connector system and by hand. The patency of the connector grafts did not differ from that of the hand-sutured grafts.