Cardiology
Examining stenting options in diabetics
By American College of Cardiology
Mar 13, 2006, 20:25

People with heart disease who also have diabetes pose specific challenges in treatment options due to the nature of their disease. A late-breaking clinical study presented today during the American College of Cardiology's inaugural Innovation in Intervention: the i2 Summit explores the outcomes of using two different types of drug-eluting stents in diabetics treated for heart disease. Innovation in Intervention: i2 Summit is an annual meeting for practicing cardiovascular interventionalists sponsored by the American College of Cardiology in partnership with the Society for Cardiovascular Angiography and Interventions.

Head-to-head studies have shown that drug-eluting stents infused with medicine to keep the artery from re-narrowing perform better than bare metal stents in patients treated for coronary artery disease. A 2005 study by Dr. Charles Simonton showed similar outcomes in the general population of patients for the two types of medicated stents currently being used in the United States.

Dr. Simonton and the STENT Group of eight coronary intervention centers have examined how the sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) performed in patients with diabetes. The STENT Group is the first prospective, consecutive, multi-center registry for drug-eluting stents in the U.S., which began enrollment in May 2003. More than 80 percent of all interventions are enrolled at the eight sites, with nine-month clinical follow-up achieved in 94 percent of patients.

A total of 1,680 diabetic patients undergoing either pure PES or pure SES procedures (i.e. no other vessels treated with other devices) were enrolled and completed nine-month follow up. Of the 498 insulin-treated diabetic patients, 235 received PES and 263 received SES. Of the remaining non-insulin-treated diabetic patients (1,182 pts), 570 received PES and 612 received SES. While PES-treated patients more frequently had high-risk or longer lesions and vessels smaller than 3 mm, baseline assessments were otherwise similar for both groups.

Nine-month follow up showed that the PES and SES stents resulted in similar outcomes in all of the diabetic patients. Major adverse cardiac events (MACE) were low, but researchers noticed for insulin-treated diabetes, PES treatment resulted in fewer adverse event rates than SES treatment. Specifically, PES was associated with reduced rates of death (2.1 percent vs. 5.7 percent), heart attack (1.3 percent vs. 1.9 percent), restenosis or renarrowing of the artery (3.4 percent vs. 4.2 percent) and overall MACE (5.9 percent vs. 10.6 percent). After adjusting for the differences in the two stent groups, the relative chance of a MACE event in the insulin-treated group was 52 percent lower for the PES patients than the SES patients. All differences between PES and SES were not statistically significant.

"In examining patients with diabetes, both stents seem to perform very nicely in terms of controlling restenosis in follow up, comparing favorably to the restenosis rates in non-diabetics. There may be a trend favoring the paclitaxel stent in patients that are insulin-requiring diabetics, but further study is needed to confirm the differences," said Dr. Simonton, of the Carolinas Medical Center, Charlotte, N.C., and lead author of the study. "Clinical practice should not be changed based on the results of this study; rather the question should be revisited in a randomized trial to determine important differences between the two stents."

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