- Question
- Does a sirolimus-eluting stent reduce neointimal proliferation and restenosis compared with a standard uncoated stent in patients with angina?
- Design
- Randomized, double-blind trial enrolling 238 patients at 19 medical centers, with clinical follow-up of up to one year.
- Population
- Patients with angina pectoris and a single primary lesion in a native coronary artery who were candidates for revascularization.
- Intervention
- Implantation of a sirolimus (rapamycin)-eluting stent.
- Control
- Implantation of a standard uncoated stent.
- Primary outcome
- In-stent late luminal loss, defined as the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months.
- Results
- At six months, late luminal loss was -0.01±0.33 mm with the sirolimus stent versus 0.80±0.53 mm with the standard stent (P<0.001). No patient in the sirolimus group had restenosis of 50% or more, compared with 26.6% in the control group (P<0.001). Major cardiac events occurred in 5.8% versus 28.8% (P<0.001).
- Safety
- There were no episodes of stent thrombosis. The difference in clinical events was due entirely to a higher rate of target-vessel revascularization in the standard-stent group.
- Conclusion
- The sirolimus-eluting stent markedly prevented neointimal proliferation, restenosis, and associated clinical events compared with a standard stent.
- Why it matters
- It was among the first randomized demonstrations that a drug-eluting stent could nearly eliminate restenosis, driving the adoption of drug-eluting stents in percutaneous coronary intervention 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