Researchers found no difference in 1-year outcomes in
the Resolute zotarolimus-eluting stent compared with the Xience V
everolimus-eluting stent among patients with diabetes, according to study
results of the RESOLUTE Pooled Diabetics presented at the 2011 Transcatheter
Cardiovascular Therapeutics scientific symposium.
Other results among the data showed that the Resolute
zotarolimus-eluting stent (Medtronic) had low adverse event rates in all
patients, and low and consistent clinical outcomes in patients without
The RESOLUTE Pooled Diabetics consisted of collected
data from five RESOLUTE trials that focused on outcomes in patients with CAD
and diabetes. Of the 5,130 patients enrolled across the five trials, 1,535
patients with diabetes were treated with the Resolute zotarolimus-eluting stent
and were compared with 270 patients who received a Xience V everolimus-eluting
stent (Abbott) in the randomized Resolute All Comers trial.
In a post-hoc analysis of 1-year results, patients with
diabetes who received a Resolute zotarolimus-eluting stent experienced 7.8%
target lesion failure, 4% target lesion revascularization, 4.7% cardiac
death/target vessel MI and 1% definite/probable stent thrombosis vs. 9% target
lesion failure, 5% target lesion revascularization, 4.9% cardiac death/target
vessel MI and 0.8% definite/probable stent thrombosis in patients with a Xience
V everolimus-eluting stent.
Patients without diabetes (n=3,595) who received a
Resolute zotarolimus-eluting stent experienced 6.1% target lesion failure, 2.9%
target lesion revascularization, 3.6% cardiac death/target vessel MI and 0.7%
definite/probable stent thrombosis vs. 8.3% target lesion failure, 3% target
lesion revascularization, 5.7% cardiac death/target vessel MI and 0.7%
definite/probable stent thrombosis in patients (n=882) with a Xience V
“We know from all the studies, from first
generation or even the bare stent, that patients with diabetes do worse than
nondiabetics, but if you use the Resolute stent, there was no difference
anymore between the nondiabetics or the diabetics related to cardiac
events,” Sigmund Silber, MD, FACC, FESC, director of the Heart
Centre at the Isar in Munich, Germany, said in an interview with Cardiology
Today. “But this is true only for those diabetics who are not on insulin.
Those who are on insulin do worse.”
Patients with diabetes (n=455) who were on insulin
experienced 6.3% target lesion failure vs. 3.1% in noninsulin diabetic patients
(n=1,080) and 2.9% in patients without diabetes (n=3,595). Cardiac death and
target vessel MI was experienced in 6.6% of diabetic patients on insulin,
whereas it was only experienced in 3.8% of diabetic patients not on insulin and
3.6% of nondiabetic patients. Definite/probably stent thrombosis was low, only
experienced in 1.5% of diabetic patients on insulin, 0.8% of diabetic patients
not on insulin and 0.7% of nondiabetic patients.
“The question is: Why do patients on insulin do
worse than patients not on insulin with diabetes?” Silber said. “You
could say they [are on] insulin because they are sicker. You don’t give
healthy diabetics insulin. That’s one explanation. The other explanation
could be what some endocrinologists think, which is insulin is a bad thing and
you should postpone the decision to give insulin much later than usual. It may
be done too early. So insulin may deteriorate the outcome of the patient, but
this is only theory. We don’t know.” – by Casey Murphy
Disclosure: Dr. Silber reports no relevant
For more information:
- Silber S. TCT-81. Oral Abstracts: Intersection of Diabetes and PCI.
Presented at: the 2011 Transcatheter Cardiovascular Therapeutics Scientific
Symposium; Nov. 7-11, 2011; San Francisco.