September 27, 2008



Mr. Kerry N. Weems
Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Ave., S.W.
Washington, D.C. 20201

Dear Mr. Weems:

The Society of Thoracic Surgeons (STS) welcomes
the opportunity to comment on the off label use
of drug eluting coronary stents (DES) as a
potential National Coverage Determination (NCD)
topic.

We believe that the Medicare Evidence Development
and Coverage Advisory Committee (MedCAC) was
correct in identifying, as part of its
evidentiary priority setting process, the
effectiveness of DES as an area in need of
greater study. There is a growing body of
research that indicates that DES is not a
clinically appropriate intervention for coronary
disease in certain patient populations. The STS
specifically encourages CMS to take note of
initial results of a study released in September
that found that DES placement in patients with
multivessel or left main coronary disease may not
be the best treatment option.

The findings are from an international trial
(Synergy between PCI with TAXUS drug-eluting
stent and Cardiac Surgery – SYNTAX), which
included key investigators from the United
States, of 1,800 patients with three-vessel and
left main disease that compares percutaneous
coronary intervention (PCI) using DES with
coronary artery bypass graft (CABG) surgery.
Specifically, the study found that at one year,
patients who received PCI had a higher rate of
adverse cardiovascular or cerebrovascular events
(death, heart attack, stroke, repeat
revascularization) than those patients who
underwent CABG, 17.8 percent vs. 12.1 percent
respectively. Of particular note, there was a
significantly higher rate of repeat
revascularization in the DES group compared to
the CABG group (13.7 percent vs. 5.8 percent).
The findings were presented at the European
Society of Cardiology Congress in Munich, Germany.

The findings are consistent with other studies
looking at the use of DES. A study published in
the Jan. 24, 2008 issue of the New England
Journal of Medicine found that patients who
received DES compared to those who underwent CABG
had higher rates of mortality and repeat
revascularization. Those study findings were
based upon a review of the New York State
Department of Health database that contained
outcomes information on 9,963 patients who
received DES and 7,437 patients who underwent
CABG. Notably, of the patients that received DES,
30.6 percent underwent repeat revascularization
within 18 months, compared to a 5.2 percent
incidence of revascularization after CABG.

We firmly believe that patients with coronary
disease need to have a full understanding of
their treatment options and the risk and benefits
of those options. The explosive growth in PCI
over the past decade is attributable, in part, to
improved techniques and technology. The evidence
shows, however, that many of these patients may
be inappropriately receiving PCI and would be
better candidates for CABG or medical therapy.
The use of DES in patients with complex coronary
disease is a patient safety issue that we believe
warrants study of current Medicare payment
policies for off label use.

Databases maintained by STS and the American
College of Cardiology (ACC) contain more than
seven million patient records on CABG and
stenting, respectively. The STS welcomes
partnership with the ACC and the Food and Drug
Administration (FDA) so that comprehensive
longitudinal study of patients who receive
stenting and CABG can occur.

The STS appreciates the opportunity to comment on
the issue of off label use of DES and offers
itself as a resource as CMS continues to examine
this important issue. Please do not hesitate to
contact me at 312-202-5800 if I can be of further
assistance.

Sincerely,


W. Randolph Chitwood, Jr., M.D.
President
The Society of Thoracic Surgeons