SPIRIT PRIME: EES Efficacy ‘Similar and Consistent’ with Xience V Technology

SAN FRANCISCO, CALIF.—Results from the prospective, non-randomized SPIRIT PRIME trial showed that the Xience Prime and Xience Prime LL stents met the primary endpoint for target lesion failure at 1 year in two patient populations. Marco A. Costa, MD, PhD, professor of medicine at University Hospitals-Case Medical Center in Cleveland, presented the results during a session Tuesday night.

In SPIRIT PRIME, EES were used in subjects with symptomatic heart disease due to a maximum of two de novo native coronary lesions, each in a different epicardial vessel.

Costa said the efficacy of Xience Prime [and Xience Prime LL] is “similar and consistent” with Xience V technology that has long been accepted in practice. At 1 year, SPIRIT PRIME met its primary endpoint goals in both the Core Size Registry (Figure 1) and Long Lesion Registry (Figure 2) patient populations.

“We can see the performance goal was met regardless of the type of comparison and we had very good margin of safety and success for this technology,” he said. “We were successful by achieving the primary endpoint for the Xience Prime, both for the Core Size and as well as for the Long Lesion cohort.”

Researchers treated 401 Core Size Registry (33 mm) lesions and 104 Long Lesion Registry (37 mm) lesions, with a total of 530 Xience Prime and 105 Xience Prime LL (both Abbott Vascular) stents implanted. Clinical device success rate was 98.2% in the Core Size Registry and 97.6% in the Long Lesion Registry.

Researchers determined trial success by comparing results with a set of performance goals drawn from historical control data using 1-year target lesion failure rates from studies such as SPIRIT II, III and IV.

Among the key secondary endpoints, rate of any death was 0.8% in the Core Size Registry and 1.0% in the Long Lesions Registry. Rate of all revascularization was 6.8% in the Core Size Registry and 8.7% in the Long Lesions Registry. Rate of clinically indicated target lesion revascularization was 2.5% in the Core Size Registry and 2.9% in the Long Lesions Registry. Rate of clinically indicated target vessel revascularization was 4.5% in the Core Size Registry and 4.8% in the Long Lesions Registry.