- Question
- Does a slow-release, polymer-based paclitaxel-eluting stent reduce clinical and angiographic restenosis compared with a standard bare-metal stent?
- Design
- Prospective, randomized, double-blind study conducted at 73 U.S. centers, enrolling 1314 patients. Angiographic follow-up was prespecified at nine months in 732 patients.
- Population
- Patients receiving a stent in a single, previously untreated coronary stenosis, with vessel diameter of 2.5 to 3.75 mm and lesion length of 10 to 28 mm. Diabetes mellitus was present in 24.2 percent.
- Intervention
- Slow-release, polymer-based paclitaxel-eluting stent, identical in appearance to the bare-metal stent (662 patients).
- Control
- Bare-metal stent (652 patients).
- Primary outcome
- Ischemia-driven target-vessel revascularization at nine months.
- Results
- Ischemia-driven target-vessel revascularization at nine months was 4.7 percent with the paclitaxel-eluting stent versus 12.0 percent with the bare-metal stent (relative risk 0.39; 95 percent CI, 0.26 to 0.59; P<0.001). Angiographic restenosis fell from 26.6 percent to 7.9 percent (relative risk 0.30; 95 percent CI, 0.19 to 0.46; P<0.001).
- Safety
- Safety outcomes were similar between groups: cardiac death or myocardial infarction occurred in 4.7 percent and 4.3 percent, and stent thrombosis in 0.6 percent and 0.8 percent, respectively.
- Conclusion
- Compared with bare-metal stents, the paclitaxel-eluting stent was safe and markedly reduced clinical and angiographic restenosis at nine months.
- Why it matters
- It provided large-scale, double-blind, randomized evidence that a drug-eluting stent substantially lowers the need for repeat revascularization procedures, supporting the adoption of these devices in practice.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026