Rosiglitazone Appears to Reduce In-Stent Restenosis
The peroxisomal proliferator–activated receptor-gamma agonist rosiglitazone appears to reduce the risk of in-stent restenosis in atherosclerotic coronary arteries, a new study shows.
Sung Hee Choi, MD, a fellow in the Division of Endocrinology in the Department of Internal Medicine, Yonsei University College of Medicine, in Seoul, Korea, presented the findings here on June 14th at the American Diabetes Association’s 63rd Annual Scientific Sessions.
The double-blind, placebo-controlled, prospective trial was undertaken after animal studies suggested that rosiglitazone inhibits vascular smooth muscle cell growth and migration, factors believed to lead to restenosis, Dr. Choi said. Because neointimal proliferation is accelerated in diabetic patients, the rate of in-stent restenosis in these patients has reached up to 51%, compared with 25% in non-diabetic patients, she said.
The trial enrolled 97 patients with diabetes, whose average age was 60 years, in whom angiography had revealed coronary artery blockages. The patients were randomised to either a loading dose of 8 mg of rosiglitazone before coronary angiography and stent placement, followed by 4 mg of rosiglitazone for 6 months or placebo on the same schedule. At the end of the 6-month period, coronary angiography was repeated.
The patients were allowed to continue on conventional diabetes therapy, such as sulfonylureas or biguanides, with doses adjusted to meet standard targets. Restenosis was defined as lesions in which more than 50% of the implanted stent lumen had stenosis on quantitative coronary angiography.
Final analysis included 35 patients with 47 stents in the rosiglitazone arm and 38 patients with 50 stents in the placebo arm. No one dropped out due to rosiglitazone-related side effects, Dr. Choi said
At 6 months follow-up, 11.4% of 35 patients in the rosiglitazone arm had restenosis, compared with 44.7% of 38 patients in the control group, the study showed.
When the results were analysed based on the total number of stents implanted, the results were similar: 10.2% of the 47 stented lesions in the treated patients had restenosis, compared with 36% of the 50 lesions in placebo patients (P<0.001), Dr. Choi reported. “While weight gain can be a problem with rosiglitazone, body weight and blood sugar levels were not significantly different between the two groups after 6 months,” she added. However, C-reactive protein levels were significantly lower in the rosiglitazone group than in the placebo arm — 1.4 mg/L versus 0.6 mg/L (P<0.01), the study showed. C-reactive protein is a well-known marker of inflammation that has been linked to heart disease risk, Dr. Choi noted. “A Äperoxisomal proliferator–activated receptor-gammaÅ agonist can be used not only for glucose lowering and insulin sensitising, but also for this anti-inflammatory effect,” she concluded.
