XIENCE V USA: EES shows long-term safety, efficacy in bifurcation lesions
Four-year results of the XIENCE V USA study demonstrated that the everolimus-eluting stent was safe and effective in patients with bifurcation lesions.
The researchers aimed to assess long-term outcomes in 5,054 patients with one bifurcation lesion treated with the Xience V everolimus-eluting stent (EES; Abbott Vascular). Eligible patients for the single-arm, multicenter, real-world study included those who did not undergo a staged procedure.
Definite/probable stent thrombosis as defined by Academic Research Consortium (ARC) criteria served as a primary endpoint, along with a composite outcome of cardiac mortality and ARC-defined MI.
Data were reported for 4,459 patients who did not undergo a staged procedure, of whom 466 had a bifurcation lesion and 3,993 did not.
One-year results indicated a 1.84% rate of definite/probable stent thrombosis in the bifurcation arm and 0.76% in the nonbifurcation lesion arm (P = .03). This trend held through 4 years, with 2.3% of patients in the bifurcation lesion arm and 1.4% of those in the nonbifurcation lesion arm experiencing ARC definite/probable stent thrombosis.
There was no incremental definite/probable stent thrombosis reported for the bifurcation arm between years 2 and 4.
Cardiac mortality and MI occurred in 13.5% of patients with bifurcation lesions and 14.1% of those without at 4 years (P = .78). Other 4-year outcomes indicated target lesion failure rates of 19.1% in the bifurcation arm and 18.3% in the nonbifurcation arm (P = .66). Rates of ischemia-driven target lesion revascularization also were similar (10.2% vs. 10.1%; P = .89).
The results showed no difference in in-hospital Q-wave MI rates (0% in bifurcation arm vs. 0.3% in nonbifurcation arm; P = .38). Non–Q-wave MI rates also were similar (P = .11).
“Treatment of [bifurcation lesions] remains a difficult and challenging endeavor,” the researchers concluded. “Multiple factors effect outcomes such as the treatment strategy, angulation of the side branch and degree of side branch disease. However, with continued improvement in platforms, drug delivery systems and technique, outcomes are improving.” – by Rob Volansky
Disclosure: Hermiller reports consulting for Abbott Vascular. See the full study for a list of the other researchers’ relevant financial disclosures.