Resolute stent showed positive 1-year results in patients with diabetes

Issue: December 2011

TCT 2011

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 diabetes.

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 everolimus-eluting stent.

“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 financial disclosures.

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.

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