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New England Journal of Medicine Publishes Results from Boston Scientific's Landmark SYNTAX(TM) Trial
Date:2/18/2009

ese patients."

The SYNTAX trial enrolled 1,800 patients in its randomized arm, using an innovative consecutive enrollment methodology. All patients were assessed by a multidisciplinary team including an interventional cardiologist and a cardiac surgeon. If both the cardiologist and surgeon felt they could offer equivalent complete revascularization, patients were randomized 1:1 into one of the two treatment strategies (PCI or CABG). If either the cardiologist or surgeon felt that one revascularization technique was the preferred treatment, then patients were not randomized, but were entered into the corresponding registry. Accordingly, patients in the PCI registry had been rejected for cardiac surgery, and patients in the CABG registry had been rejected for PCI.

The patients recruited in the SYNTAX trial are a unique study group in the PCI field, given their exceptionally complex anatomy and advanced disease. The average PCI-treated patient enrolled in SYNTAX received 4.6 stents. By contrast, the average number of stents implanted in a PCI patient in everyday practice is 1.5. Further evidence of the complex nature of PCI-treated patients enrolled in SYNTAX include 33 percent of patients with >100 millimeters stented length, 72 percent with bifurcations, 22 percent with total occlusions and 39 percent with left main disease.

The final one-year results published today showed similar safety for the two randomized groups, with a combined rate of all-cause death, stroke and myocardial infarction (MI) of 7.6 percent for PCI and 7.7 percent for CABG (p=0.98). The rate of stroke itself was significantly lower for PCI (0.6 percent for PCI as compared to 2.2 percent for CABG, p=0.003). Overall 12-month MACCE (all-cause death, stroke, MI and repeat revascularization), however, was significantly higher for PCI (17.8 percent versus 12.4 percent, p=0.002), due to more repeat revascularization in the PCI arm (13.5 p
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SOURCE Boston Scientific Corporation
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