The SYNTAX trial is the first randomized, controlled clinical trial to compare PCI using drug-eluting stents (DES) to CABG in patients with left main disease and three-vessel disease. These patient groups are typically treated with CABG and represent a population with far more complex anatomy and advanced disease than those studied in prior DES clinical trials. The goal of the trial is to expand the body of knowledge of PCI use and help inform physicians on appropriate treatment options for the sickest patients.
Keith awkins, M.D., Associate Chief Medical Officer of Boston Scientific said, For PCI patients to do so well with such complex anatomy and advanced disease is extraordinary. These patients, the majority of whom are normally treated with surgery, are the most challenging group ever studied in a DES clinical trial.
Dr. Dawkins, The significant difference in the stroke rate between the PCI and the CABG groups is an important finding. Physicians and their patients will 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.
SYNTAX is breaking new ground by scientifically defining a new measure for anatomical complexity – the SYNTAX Score – which seeks to provide guidance to physicians on optimal treatment options for this high-risk group of patients. The SYNTAX Score characterizes vasculature based on lesion frequency, complexity and location, relying on data from the SYNTAX trial as well as information collected through other sources.
The safety and effectiveness of the TAXUS Express2 Stent System has not been established in patients with left main or three-vessel disease.