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Paclitaxel-Eluting Stents Top Angioplasty for Preventing Restenosis: Presented at ACC

By Jill Stein

ATLANTA, G.A. -- March 13, 2006 -- The treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents instead of angioplasty followed by vascular brachytherapy (VBT) reduces 9-month restenosis and improves event-free survival, researchers said in a late-breaking clinical trials session at the 55^th Annual Meeting of the American College of Cardiology (ACC).

The results, presented on March 12^th, will also be published on March 15^th in JAMA-Express (JAMA 2006;295:1253-1263).

Before the present study, the safety and efficacy of this stent in patients with bare-metal in-stent restenosis had been shown in a small series of patients.

Gregg Stone, MD, director of research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, New York, reported results in 396 patients who were randomized to undergo angioplasty followed by VBT with a beta-source or the polymer-based, slow-release paclitaxel-eluting stent implantation. The trial is known as the TAXUS V ISR Randomized Trial.

All subjects were at least 18 years of age and had developed in-stent restenosis of a previously implanted bare-metal coronary stent.

The primary outcome measure was ischemia-drive target vessel revascularization at 9 months.

For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target-vessel revascularization were 13.9% versus 6.3% (RR [Risk Ratio] = 0.45, P =.01); for ischemic target vessel revascularization, 17.5% versus 10.5% (RR = 0.60, P =.046), and for overall major adverse cardiac events, 20.1% versus 11.5% (RR = 0.57, P =.02).

The rates of cardiac death or myocardial infarction and target vessel thrombosis were similar in the 2 treatment arms.

Only 14.5% of the paclitaxel-eluting stent group had angiographic restenosis at 9 months compared with 31.2% of the VBT group (RR = 0.47, P <.001).

"Our results combined with findings from other trials demonstrate that drug-eluting stents should now be considered the preferred treatment for the majority of patients with in-stent restenosis of previously implanted bare-metal stents," Dr. Stone said.

He added that more studies are needed to document the long-term safety and durability of this approach.


[Presentation title: Paclitaxel-Eluting Stents vs. Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents. Presented in a Late-Breaking Clinical Trials Session]

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