Long-term target lesion revascularization, adverse events low with SES

27 March 2008

MedWire News: Patients treated with sirolimus-eluting stents (SES) have low constant rates of target lesion revascularization, stent thrombosis, and major cardiac adverse events over time, Israeli researchers report.

"Our study convincingly demonstrated that off-label use is an important risk factor for adverse events and that the increased risk attributed to off-label use continues over time of follow-up," the authors add.

David Planer (Rambam Medical Centre, Haifa) and colleagues evaluated long-term (3.4 years) clinical outcomes in 479 patients treated with SES who were enrolled in the Israeli arm of the e-Cypher registry.

During the 3.4 years of follow-up, 6.3% of the patients died (3.9% cardiac and 2.4% non-cardiac deaths).

Overall, 4.0% of patients had stent thrombosis, 9.9% had target lesion revascularization, and 16.3% experienced major adverse cardiac events - a combination of death, myocardial infarction, and target lesion revascularization.

The researchers note that the rate of in-stent restenosis remained relatively low, and the incidence of late-stent thrombosis was constant throughout the follow-up period.

Renal failure, stent length, and off-label use of SES independently predicted stent thrombosis, with hazard ratios of 9.6, 1.1, and 5.3, respectively.

Notably, 87% of stent thrombosis cases and 85% of all major adverse cardiac events occurred in patients receiving SES for off-label indications.

"A critical question that remains open is what is the added risk for adverse events associated with off-label indications compared with the benefit of significantly reducing target lesion revascularization in this high-risk patient population," Planer and co-workers write in the American Journal of Cardiology.

Am J Cardiol 2008; 101: 953-959