With regard to drug-eluting stents for the prevention of restenosis in native coronary arteries, the ICSI Technology Assessment Committee finds:
- Drug-eluting stents have been shown in prospective, randomized trials to significantly decrease the rate of restenosis, repeat revascularization procedures, and cardiac events up to 1 year post-treatment as compared with bare metal stents in selected native coronary lesions of up to 30 mm in vessels with diameters of 2.25 to 3.5 mm that have not been previously stented (Conclusion Grade I). At present, there are no data from peer-reviewed randomized trials to permit a conclusion to be reached about the safety and efficacy of drug-eluting stents for other patient populations, other lesions sizes, or other vessel diameters.
- Placement of drug-eluting stents followed by antiplatelet therapy has shown no statistically significant added risk of death or MI compared to placement of bare metal stents. The use of antiplatelet therapy with ticlopidine or clopidogrel in addition to aspirin for 3 to 6 months post-treatment was the protocol used in randomized trials.
- Long-term safety and efficacy of drug-eluting stents are unknown at this time.