At 2 years, zotarolimus-eluting stents safe, effective in patients with diabetes

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 - clinical trial

Resolute zotarolimus-eluting stents were found to be as safe and effective after two years in small vessels and in patients with diabetes as those with larger diameters or patients without diabetes. In diabetic patients, outcomes were not significantly different between larger and smaller vessel diameters.

Published July 1 in Catheterization and Cardiovascular Interventions, the Resolute zotarolimus-eluting stent (Medtronic) performance trial sought to determine safety and efficacy across the populations of several prior studies.

According to research team led by Ronald Caputo, MD, of St. Joseph’s Hospital Cardiology of Liverpool, N.Y., second-generation drug-eluting stents have sought to address the problems with smaller vessels through changes in the design of the struts, antiproliferative drugs and biocompatible polymers.

The two-year event rates for the small- and large-vessel groups were comparable. In target vessels smaller than or equal to 2.5 mm, 10.1 percent target lesion failure was reported, while in larger vessels the rate was 8.7 percent.

Cardiac death occurred in small- and large-target vessel cohorts at a rate of 2 percent and 2.4 percent, respectively. A very low rate of stent thrombosis was reported: small vessels at 0.8 percent and larger vessels at 1 percent.

The rates for target vessel MI and revascularization in the small-vessel cohort were 3.9 percent and 5.3 percent, respectively. The larger-vessel cohort experienced MI and revascularization rates of 3.2 percent and 4.4 percent, respectively. 

Patients with small and large vessels who were diabetic saw the same rate of target lesion failure (11.2 percent vs 11.1 percent), although nondiabetics had a lower rate (9.6 percent). MI rates were the same across diabetics and nondiabetics, small and large vessels. The highest percent of cardiac death occurred in diabetics with large vessels (4 percent), decreasing in the smaller-vessel diabetics (2.7 percent) and those patients without diabetes (1.7 percent).

Target lesion revascularization rates were highest for small-vessel diabetics (6.3 percent), but rates for large-vessel diabetics (5.4 percent) and nondiabetics (4.8 percent) were similar. Differences in stent thrombosis were minimal (0.8 percent vs 0.9 percent vs 1.4 percent).

These findings were relatively consistent with other stent trials at two years. However, as stated by Caputo et al, this trial was unique in reviewing stent outcomes against diabetic status.

This study was sponsored by Medtronic.