NEW YORK (Reuters Health) – In real-world contemporary clinical practice, the use of the XIENCE V everolimus-eluting coronary stent is associated with lower mortality and reduced stent thrombosis than that seen with the earlier-generation drug-eluting stents (DESs), a Washington DC group reports in the American Journal of Cardiology online February 17.
However, “The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates,” note Dr. Ron Waksman and colleagues at Washington Hospital Center.
To assess the safety and efficacy of the everolimus stent in unselected patients outside the setting of a clinical trial, the team retrospectively compared outcomes in 6069 patients treated at their institution from 2003 to 2009 with the XIENCE V stent or the CYPHER sirolimus-eluting stent or the TAXUS paclitaxel-eluting stent.
The 1-year rate of major adverse cardiovascular events (MACE) was not significantly different in the three groups at 9.3%, 9.8% and 11.5%, respectively (p=0.11), the authors found. Target lesion revascularization rates were also similar at 5.9%, 5.2% and 5.6%, respectively (p=0.34).
On the other hand, 1-year mortality was lower in the XIENCE group than the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%; p <0.001), as was the incidence of stent thrombosis (0.2% vs 1.2% vs 0.7%; p=0.007).
“The present study failed to show clear clinical superiority of the XIENCE V over the first-generation DESs despite a decrease in stent thrombosis and all-cause mortality,” Dr. Waksman and colleagues conclude.
They suggest several possible reasons for this. One is that outcomes in diabetic patients have been shown in clinical trials to be no better with the everolimus-eluting stent than with the paclitaxel-eluting stent. “In the present study, 1/3 of the patients had diabetes, which might have diluted the effects of XIENCE V among the entire cohort,” the authors suggest.
The also point out that during the relatively long study period “changes in patient standard of care (e.g., duration of dual antiplatelet regimen, stent deployment techniques) might have influenced the outcome, irrespective of the stent used.”
Am J Cardiol 2012.
