Second-generation drug-eluting stent system is safe and effective after two years

January 24, 2013 – The DCRI’s Mitchell Krucoff, MD, and researchers from across the country studied two-year outcomes of patients who received the XIENCE V® everolimus-eluting coronary stent system (EECSS).

The XIENCE V® everolimus-eluting coronary stent system (EECSS) is safe and effective for cardiac patients, according to a new study of two-year outcomes by the DCRI’s Mitchell Krucoff, MD, and colleagues from several other institutions.

The study appears in the December 2012 issue of the Journal of Interventional Cardiology.

The EECSS is a type of drug-eluting stent (DES), a tube coated with medications that is inserted into a blood vessel during an angioplasty. Studies of the first generation of DES suggested that there was a small chance that a blood clot could form on the surface of the stent, a condition known as stent thrombosis. The EECSS is a second-generation DES, and additional studies have shown that it improves clinical outcomes. However, those studies were conducted with relatively small, homogeneous populations that did not necessarily represent real-world conditions. They also did not focus on patient outcomes after one year.

The current study was designed to determine two-year clinical outcomes of patients treated with the EECSS under real-world conditions. The researchers used data from the XIENCE V® USA trial, a prospective, open-label, multicenter, observational study designed to evaluate continued safety and effectiveness of the EECSS during commercial use in real-world settings. For the current study, researchers examined data from 4,873 of the original 5,054 XIENCE V® USA participants who reached the two-year follow-up point.

In examining the data, the researchers found that the overall rate of stent thrombosis among all EECSS patients after two years was relatively low (0.96 percent). The rate of very late stent thrombosis, in which the condition develops more than one year after stent implantation, was also low (0.06 percent) despite the fact that many patients discontinued the use of antiplatelet therapy within two years. Patients considered high risk (those with large or numerous blood clots, impaired heart or kidney function, and a history of previous cardiac surgeries) had only a moderately increased risk of stent thrombosis when compared with normal-risk patients (1.33 percent and 0.34 percent, respectively).

These findings, the researchers concluded, demonstrate the overall safety and effectiveness of the EECSS in real-world conditions.