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Landmark SYNTAX Trial Reports Comparable Safety Outcomes for Complex Patients Treated With TAXUS(R) Express2(TM) Stents or Bypass Surgery
Date:9/1/2008

now have the necessary information to weigh the risk of stroke associated with CABG versus the known higher rate of revascularization with PCI. We were also surprised to find that the rate of symptomatic graft occlusion in the CABG group was equivalent to the rate of stent thrombosis in the PCI group."

The patients recruited in SYNTAX are a unique study group in the PCI field, given their exceptionally complex anatomy and advanced disease. The average SYNTAX 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 patient profile includes 33 percent of patients with >100 mm stented length, 84 percent with bi/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 results announced today showed comparable safety for the two treatment groups, with a combined rate of all-cause death, stroke and MI of 7.6 percent for PCI and 7.7 percent for CABG (p=0.98). The rate of stroke itself was 0.6 percent for PCI as compared to 2.2 percent for CABG (p=0.003). Overall 12- month MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate, including all-cause death, stroke, MI and repeat revascularization) was significantly higher for PCI (17.8 percent compared to 12.1 percent for CABG, p=0.0015).

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 o
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SOURCE Boston Scientific Corporation
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