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Boston Scientific releases one-year data from SYNTAX trial

Boston Scientific : 01 September, 2008  (Company News)
Boston Scientific has released one-year data from its landmark SYNTAX trial comparing percutaneous coronary intervention (PCI) using the Taxus Express2 Paclitaxel-Eluting Coronary Stent System to contemporary coronary artery bypass graft (CABG) surgery.
The overall results demonstrated no statistically significant differences between PCI and CABG in rates of death or myocardial infarction (MI). The company made the announcement at the annual European Society of Cardiology meeting in Munich, Germany.

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.

'For PCI patients to do so well with such complex anatomy and advanced disease is extraordinary,' said Keith Dawkins, MD, associate chief medical officer of Boston Scientific. 'These patients, the majority of whom are normally treated with surgery, are the most challenging group ever studied in a DES clinical trial.'

The SYNTAX trial also demonstrated a significant decrease in the rate of stroke for patients treated with PCI as compared to CABG.

'The significant difference in the stroke rate between the PCI and the CABG groups is an important finding,' said Dr Dawkins. '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 less than 100mm 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 option, then patients were placed in one of two parallel registries for PCI or CABG.

SYNTAX is 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 characterises 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.
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