How do long-term clinical outcomes compare between sirolimus-eluting stents and bare metal stents?

Sirolimus-eluting stents (SES) reduced long-term target lesion revascularization and reduced overall major adverse cardiac events compared with bare metal stents (BMS). (LOE = 1b)

Morice M, Serruys PW, Barragan P, et al. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol 2007;50(14):1299-1304.  [PMID:17903626]

Randomized controlled trial (double-blinded)

Industry

Concealed

Inpatient (any location) with outpatient follow-up

The RAVEL trial randomized patients who required single stents to SES or BMS. The funding industry manufactures both of these devices. Patients received postprocedural dual antiplatelet therapy with aspirin indefinitely and clopidogrel or ticlopidine for 8 weeks. The primary end point was angiographic in-stent stenosis at 6 months. This paper reported the 5-year rate of target lesion revascularization. Analyses were done by intention to treat. The study included 238 patients. Groups were matched for baseline characteristics, except for a higher percentage of men in the BMS group. Follow-up was complete for 92.5% of the SES group (14 deaths, 4 lost to follow-up) and 89.1% of the BMS group (8 deaths, 9 lost to follow-up). The rate of target lesion revascularization was lower in the SES group [number needed to treat (NNT) = 6; 95% CI, 4 - 15]. Overall major adverse cardiac events were reduced in the SES patients. This study is limited by its small size, and was not powered to detect significant differences in mortality or myocardial infarction.