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Slow-Release, Paclitaxel-Eluting Stent Limits Restenosis

Results are in from the TAXUS-IV trial.

Drug-eluting stents have quickly become the most frequently used devices for PCI because they limit restenosis and subsequent target-vessel revascularization (TVR) more than bare-metal stents do. The FDA has approved a sirolimus-eluting stent and is likely to approve a paclitaxel-eluting stent soon. In a manufacturer-funded, multicenter, double-blind trial (TAXUS-IV), U.S. researchers randomized 1326 patients with a single lesion to either a slow-release, paclitaxel-eluting stent or a bare-metal stent. Paclitaxel is a microtubule inhibitor that limits cell division and migration.

TVR incidence at 9 months (the primary endpoint) was a significant 61% lower in the paclitaxel group (5%) than in the bare-metal group (12%). Nine-month angiography in a prespecified subgroup revealed significant differences in restenosis (8% with paclitaxel vs. 27% with bare metal) and in mean late loss of in-stent luminal diameter (0.39 mm vs. 0.92 mm, respectively). The paclitaxel stent was especially beneficial in diabetes patients.

The paclitaxel and bare-metal groups had similar rates of adverse events at 9 months. For example, rates of subacute stent thrombosis were 0.6% and 0.8%, respectively.

Comment: In TAXUS-IV, a slow-release, paclitaxel-eluting stent markedly reduced 9-month risks for TVR and angiographic restenosis. Like the sirolimus-eluting stent tested in the SIRIUS trial (Journal Watch Cardiology Nov 14 2003), the paclitaxel stent did not yield an increased rate of subacute thrombosis. Head-to-head trials of different types of drug-eluting stents must be conducted to compare them accurately on specific endpoints. For now, as the editorialist notes, we can only hope that new drug-eluting stents will further improve outcomes and reduce costs.

— Howard C. Herrmann, MD

Published in Journal Watch Cardiology February 27, 2004

Citation(s):

Stone GW et al. for the TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004 Jan 15; 350:221-31.

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• Medline abstract (Free)

Lee TH. "Me-Too" products -- Friend or foe? N Engl J Med 2004 Jan 15; 350:211-2.

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• Medline abstract (Free)