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SYNTAX Data Show Comparable Safety for Complex Patients Treated with TAXUS(R) Express2(TM) Stents and Bypass Surgery
Date:10/14/2008

cantly higher in the PCI group (12.0 percent for PCI versus 6.7 percent for CABG, p=0.02), while the rate of stroke was significantly higher in the CABG group (2.7 percent for CABG versus 0.3 percent for PCI, p=0.009). The subset results for patients with three-vessel disease reported comparable overall safety outcomes for the two groups (6.4 percent for CABG versus 7.9 percent for PCI, p=0.39), an expected higher rate of revascularization for PCI (14.7 percent for PCI versus 5.4 percent for CABG, p=<0.001) driving higher overall MACCE for the PCI group (19.1 percent versus 11.2 percent for CABG, p=<0.001).

The patients enrolled in SYNTAX are a unique study group in the PCI field, given their exceptionally complex anatomy and advanced disease. The average SYNTAX PCI patient received 4.6 stents, with one patient having 14. By contrast, the average number of stents implanted in a PCI patient in everyday practice is 1.5. In addition, the PCI patient profile includes 33 percent of patients with >100 mm stented length, 73 percent with bifurcations, 11 percent with trifurcations, 22 percent with chronic total occlusions, and 39 percent with left main disease. Some of the sickest patients in the trial were not eligible for surgery and were treated with drug-eluting stents.

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 methods (PCI or CABG). If either the cardiologist or surgeon felt that PCI or CABG was the preferred option, then patients were placed in one of two parallel registries for PCI or CABG.

The safety and effectiveness of the TAXUS Express2 Stent System has not been established in patients with left
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SOURCE Boston Scientific Corporation
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