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Drug-eluting stent comparisons give slight edge to sirolimus-eluting sent
In-lesion restenosis is similar between the sirolimus-eluting stent (Cypher) and the paclitaxel-eluting stent (Taxus) when used for the treatment of routine coronary artery stenoses, but the sirolimus-eluting stent may offer an advantage in patients with diabetes, according to a study reported at the ACC Annual Scientific Session 2005.
In the international head-to-head trial, called REALITY, 1,386 patients were randomized to receive either the sirolimus- or paclitaxel-eluting stent. To be eligible, patients had to have 1 or 2 de novo lesions in a native coronary artery. Twenty-eight percent of the study population had diabetes.
The primary end point, the in-lesion binary restenosis rate as determined by quantitative coronary angiography at 8 months post-procedure, was achieved in 9.6% of patients who received the sirolimus stent and 11.1% who received the paclitaxel stent, a nonsignificant difference (P=.31).
The other angiographic parameters, however, did favor more robust inhibition of neointimal hyperplasia with the sirolimus stent, including less late loss (0.09 vs 0.31 mm, P<.001), a lower percent diameter stenosis (23.1% vs 26.7%, P<.001), and a greater mean lumen diameter (2.00 vs 1.85 mm, P<.001).
In addition, a greater number of acute and subacute stent thromboses occurred with the paclitaxel-eluting stent than with the sirolimus-eluting stent (1.8% vs 0.4%, P=.0196), which is the first indication of a "significant safety difference between drug-eluting stents," Dr Morice said.
A single-center study demonstrated that the sirolimus-eluting stent was more effective than the paclitaxel-eluting stent in preventing restenosis in the high-risk subset of patients with diabetes, said Adnan Kastrati, MD, from the Deutches Herzzentrum, Munich, Germany.
The study included 250 patients with diabetes who had angina or a positive stress test in the presence of 50% stenosis in native coronary vessels. Those patients were randomized to receive 1 of the stents and followed to 6 months with an angiographic assessment of late lumen loss, and to 9 months to compare the rate of clinical events.
In-segment late lumen loss was significantly less in the patients randomized to the sirolimus- vs the paclitaxel-eluting stent (0.43 vs 0.67 mm, P<.0001), as was in-stent late lumen loss (0.19 vs 0.46 mm, P<.0001). Angiographic restenosis occurred in 6.9% vs 16.5% (P=.03) of patients randomized to the sirolimus and paclitaxel stents, respectively.
At 9 months, the rates of mortality and myocardial infarction were not significantly different between the 2 groups.
FDA Sets Date of Advisory Committee Meeting for Donanemab in Alzheimer’s Disease
May 7th 2024The Peripheral and Central Nervous System Drugs Advisory Committee will meet on Monday, June 10, 2024, to discuss the phase 3 trial of Lilly’s donanemab to treat patients with early symptomatic Alzheimer’s disease.
