Resolute zotarolimus-eluting stent safe, effective for patients with diabetes and CAD

Two separate analyses of patient-level data demonstrate safety and efficacy of the Resolute Integrity zotarolimus-eluting stent for patients with diabetes and CAD.

“The present publication describes the effect of the Resolute zotarolimus-eluting stent on clinical outcomes in two important analyses publications: a prespecified cohort of patients from five prospectively planned and harmonized studies — on the basis of which the FDA approved the specific indication for PCI in patients with diabetes in the United States … and the full cohort of patients treated with the Resolute zotarolimus-eluting stent, including the more complex patients,” researchers wrote in JACC: Cardiovascular Interventions.

Sigmund Silber

One analysis evaluated the performance of the device (Medtronic) in 878 standard-risk patients with diabetes. A 12-month target vessel failure rate of 14.5% was prospectively determined in conjunction with the FDA as a performance goal.

According to results, the actual rate of TVF in this patient population was significantly lower at 7.8% (P<.001). Additional safety and efficacy outcomes at 12 months included: target lesion failure, 6.6%; all death, 2.8%; cardiac death and target vessel MI, 3.8%; major adverse cardiac events, 7.5%; and Academic Research Consortium definite/probable stent thrombosis, 0.3%.

Clinical outcomes data at 2 years demonstrate low and comparable rates of TLF in patients with non–insulin-treated diabetes when compared with patients without diabetes (8% vs. 7.1%). In addition, researchers found a higher 2-year rate of TLF in patients with insulin-treated diabetes (13.7%).

A second analysis evaluated the cumulative incidence of TLF at 2 years for all 5,130 patients (diabetes, n=1,535; no diabetes, n=3,595), many of whom had complex CAD. Patients with diabetes were divided into two groups: insulin users (n=455) and non–insulin-users (n=1,080).

Researchers found low and comparable 2-year rates of TLF in patients with non–insulin-treated diabetes and patients with diabetes (8.9% vs. 8.4%) and a higher rate of TLF at 2 years in patients with insulin-treated diabetes (16.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different among patients with diabetes (1.2%) and without diabetes (0.8%).

“Long-term clinical data of patients with non–insulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset,” Sigmund Silber, MD, professor and director of the Heart Center at the Isar, Munich, Germany, and colleagues wrote in the study.

The Resolute Integrity drug-eluting stent was approved by the FDA in March 2012 with a specific indication for treated the CAD of patients with diabetes.

For more information:

Silber S. J Am Coll Cardiol Intv. 2013;6(4):357-368.

Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.