1. Home>
2. Specialties>
3. Cardiology>
4. Summary and Comment

Increased Mortality with Sirolimus-Eluting Stents in Saphenous Vein Grafts?

Post-hoc results from a small study may be cause for concern.

Results from the Reduction of Restenosis In Saphenous vein grafts with Cypher sirolimus-eluting stent (RRISC) trial — a small, randomized study — demonstrated markedly lower target vessel revascularization (TVR) rates in saphenous vein graft (SVG) lesions treated with sirolimus-eluting stents (SES), compared with bare metal stents (BMS; 5% and 27%, respectively). To examine all-cause mortality in these patients, the RRISC investigators subsequently extended their study. The present analysis includes follow-up data up to 3 years.

Death occurred in 11 of the 38 patients (29%) who received SES and in none of the 37 patients who received BMS (P<0.001). Of these deaths, seven were cardiac. Antiplatelet therapy had been suspended in four patients before they died. The rate of possible or definite stent thrombosis was 13% in SES recipients and 0% in BMS recipients. At about 3 years, SES and BMS groups had similar rates of TVR (34% and 38%, respectively).

Comment: In this randomized study, the early benefit of reduced target vessel revascularization seen with sirolimus-eluting stents in saphenous vein graft lesions disappeared during 3-year follow-up, and SES was associated — ominously — with an increased risk for death. However, as the authors and editorialist note, the study has limitations, including its small size, the early discontinuation of dual antiplatelet therapy in many patients, and the fact that mortality was not a prespecified endpoint, so the study was underpowered for this outcome. Nonetheless, interventionalists should proceed with caution until larger studies confirm the benefits and risks of using drug-eluting stents for SVG lesions.

— Howard C. Herrmann, MD

Published in Journal Watch Cardiology September 19, 2007

Citation(s):

Vermeersch P et al. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: Results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol 2007 Jul 17; 50:261.

• Original article (Subscription may be required)
• Medline abstract (Free)

Ellis SG. "Crying fire in a theater" or a "confirmatory sighting?" J Am Coll Cardiol 2007 Jul 17; 50:268.

• Original article (Subscription may be required)
• Medline abstract (Free)