Drug-Releasing Coronary Stents

Feb 3, 2008
Common Drug-Releasing Coronary Stents Appear to Have
Similar Clinical Outcomes

A comparison of use of the first two commercially available
drug-releasing coronary stents (for the medications
sirolimus and paclitaxel) among patients in “everyday
clinical practice” indicates no significant differences for
outcomes such as heart attack or cardiac death, according
to a study in the January 30 issue of JAMA.1

Drug-releasing (eluting) stents are used for percutaneous
coronary interventions (PCI) to help reduce the rate of
re-narrowing of a coronary artery, according to background
information in the article. Approval of drug-eluting
coronary stents was based on results of relatively small
trials of selected patients; however, in routine practice,
stents are used in a broader spectrum of patients.

Anders M. Galløe, M.D., of the University of Copenhagen,
Denmark, and colleagues compared the efficacy and safety of
sirolimus-eluting and paclitaxel-eluting stents in a study
designed to reflect everyday clinical practice. The SORT
OUT II trial included 2,098 men and women treated with PCI
and randomized to receive either sirolimus-eluting (n =
1,065) or paclitaxel-eluting (n = 1,033) stents at five
university hospitals in Denmark.

The patients were initially treated for ST-segment
elevation myocardial infarction (STEMI; a certain pattern
on an electrocardiogram following a heart attack),
non-STEMI or unstable angina pectoris, and stable angina.

The researchers found that the proportion of patients
experiencing major adverse cardiac events, such as cardiac
death, heart attack, target lesion revascularization, or
target vessel revascularization, were 98 (9.3 percent) for
the sirolimus-eluting stent group and 114 (11.2 percent)
for the paclitaxel-eluting stent group. The stent
thrombosis rates were 27 (2.5 percent) in the
sirolimus-eluting stent group and 30 (2.9 percent) in the
paclitaxel-eluting stent group.

“In conclusion, the SORT OUT II trial found no statistical
significant differences in the primary or secondary end
points between the sirolimus-eluting stent and
paclitaxel-eluting stent in everyday clinical practice
among patients undergoing PCI for ST-segment elevation
myocardial infarction, non–ST-segment elevation myocardial
infarction or unstable angina pectoris, and stable angina.
The rates of serious adverse events, cardiac death, acute
myocardial infarction, and stent thrombosis were low,
suggesting that, at least when considering 18 months of
follow-up, the use of drug-eluting stents in the general
population may be safe,” the authors write.

In an accompanying editorial, Debabrata Mukherjee, M.D.,
and David J. Moliterno, M.D., of the University of
Kentucky, Lexington, comment on the findings of Galløe and
colleagues regarding the comparison of stents.2

“In 2008, clinicians will have additional choices of
drug-eluting stents with the availability of
second-generation devices—namely, the everolimus-eluting
stent, which yielded similar or fewer major adverse cardiac
events among patients as compared with the
paclitaxel-eluting stent, and the zotarolimus-eluting
stent, which was shown to be noninferior to the
paclitaxel-eluting stent. The ongoing choice of a
drug-eluting stent will likely depend on multiple factors
that will include safety, effectiveness, deliverability,
and—given recent cuts in reimbursement—cost of the device.”

“The current literature for drug-eluting stents can be
challenging to interpret because of differing criteria for
study enrollment, definitions for acute stent thrombosis
and other clinical end points, and varied intervals of dual
antiplatelet therapy and follow-up after stent
implantation. Similarly, current real-world registries are
usually limited by lack of valid control groups and often
use historical controls. A large longitudinal database for
patients receiving these various drug-eluting stents with
open entry to fully capture all procedures may help
determine the safest and most effective revascularization
practice possible and should help guide future
recommendations,” they write.

References:

1. JAMA. 2008; 299[4]:409-416.
2. JAMA. 2008; 299[4]:454-455.