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Paclitaxel-Eluting Stents Reduce Patient Rate of Clinical and Angiographic Restenosis When Compared With Bare-Metal Stents

Patients who received paclitaxel-eluting stents, compared with bare-metal stents, had reduced rates of clinical and angiographic restenosis, according to a prospective, double-blind trial conducted at 73 centres in the United States.

"Despite the relatively low rate of restenosis in the control group, the biologic potency of the paclitaxel-eluting stent was evidenced by a 70% relative reduction in the risk of angiographic restenosis, with a corresponding 73% reduction in the risk of target-lesion revascularisation," writes Gregg W. Stone, MD, Cardiovascular Research Foundation, New York.

The researchers randomised 662 patients to receive a slow-release, polymer-based, paclitaxel-eluting stent and 652 patients to receive an identical appearing bare-metal stent. The patients had stable or unstable angina or provokable ischaemia, and were undergoing percutaneous coronary intervention for a single, previously untreated lesion in a native coronary artery. The patients' mean reference-vessel diameter was 2.75 mm and the mean lesion length was 13.4 mm. Overall, 24.2% of the patients had diabetes mellitus.

At the 9-month follow up point, ischaemia-driven target-vessel revascularisation was 4.7% compared with 12.0%, rate of target-lesion revascularisation was 3.0% compared with 11.3%, and the rate of angiographic restenosis was 7.9% compared with 26.6% in the paclitaxel-eluting stent and the bare-metal stent groups, respectively.

The 9-month rates of death from cardiac causes or myocardial infarction and stent thrombosis were low and similar between groups, and aneurysms did not develop in any patients who received a paclitaxel-eluting stent.

The authors note that the findings of this study cannot be generalised to patients and the numerous types of lesions excluded from this study. They also note that all patients in this study took clopidogrel for 6 months, which "is consistent with current studies demonstrating an incremental benefit of extended thienopyridine therapy," however, "it is unknown whether this duration of treatment is necessary to prevent subacute thrombosis after the implantation of a paclitaxel-eluting stent."

Further evaluation of the safety and efficacy of paclitaxel-eluting stents requires "appropriately powered, head-to-head, randomised trials comparing different drug-eluting stent systems," the authors conclude.

N Engl J Med 2004;350:221-31.

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