Boston
Scientific Corporation (NYSE: BSX) announced 12-month left main and
three-vessel disease subset data from its landmark SYNTAX trial comparing
percutaneous coronary intervention (PCI) using the TAXUS(R) Express2(TM)
Paclitaxel-Eluting Coronary Stent System to contemporary coronary artery
bypass graft (CABG) surgery. The results reinforced previously announced
data demonstrating no overall statistically significant differences between
PCI and CABG in rates of death or myocardial infarction (MI). The Company
also presented an analysis of the data based on the SYNTAX Score, a new
tool that seeks to provide guidance to physicians on optimal treatment
options for this high-risk group of patients, showing similar safety and
efficacy outcomes for two thirds of SYNTAX randomized patients. The Company
made the announcements at the Cardiovascular Research Foundation's (CRF)
annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium
in Washington, D.C.
The SYNTAX trial is the first large scale randomized, controlled
clinical trial comparing 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 and patients on appropriate treatment
options for the sickest patients.
"The data announced today will provide important additional information
for doctors as they evaluate treatment options for complex coronary
patients," said Keith Dawkins, M.D., Associate Chief Medical Officer of
Boston Scientific. "The comparable safety and efficacy outcomes with PCI
and CABG in patients with left main disease in this trial indicate PCI is a
good treatment alternative for this patient population. Physicians will
also be able to consider the SYNTAX Score analysis, demonstrating no
difference in safety and efficacy outcomes between PCI and CABG in
approximately two-thirds of the SYNTAX patient population, when assessing
the appropriate treatment for their patients."
The SYNTAX Score is breaking new ground by scientifically defining a
new measure for anatomical complexity that seeks to provide guidance to
physicians on optimal treatment options for this high-risk group of
patients. The SYNTAX Score characterizes coronary anatomy based on lesion
frequency, complexity and location, relying on data from the SYNTAX trial,
and assigns a score to each patient. The analysis of the raw SYNTAX Score
data presented today demonstrated that PCI and CABG patients whose scores
fell into the lower or intermediate terciles of complexity had similar
rates of MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate,
including all-cause death, stroke, MI and repeat revascularization) at 12
months. For patients whose SYNTAX Score fell into the upper tercile --
those with the greatest lesion complexity -- there was a significant
increase in MACCE for PCI patients compared with CABG patients.
The 12-month subset results for patients with left main disease
reported comparable rates of overall MACCE for the CABG group and the PCI
group (13.6 percent for CABG versus 15.8 percent for PCI, p=0.44), as well
as similar overall safety outcomes (death, stroke, MI) for the two groups
(9.1 percent for CABG versus 7.0 percent for PCI, p=0.29). As expected, the
rate of revascularization was significantly 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=28mm in length or
requiring multiple stents.
Boston Scientific is a worldwide developer, manufacturer and marketer
of medical devices whose products are used in a broad range of
interventional medical specialties. For more information, please visit:
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