Bioresorbable Vascular Scaffold Deemed Noninferior
Noninferior to treatment with everolimus-eluting cobalt-chromium stent for coronary artery disease
TUESDAY, Oct. 13, 2015 (HealthDay News) -- For patients with noncomplex obstructive coronary artery disease, treatment with an everolimus-eluting bioresorbable vascular scaffold is noninferior to treatment with an everolimus-eluting cobalt-chromium stent, according to a study published online Oct. 12 in the New England Journal of Medicine to coincide with the Transcatheter Cardiovascular Therapeutics meeting, held from Oct. 11 to 15 in San Francisco.
Stephen G. Ellis, M.D., from the Cleveland Clinic, and colleagues conducted a multicenter, randomized trial involving patients with stable or unstable angina who were randomized in a 2-to-1 ratio to receive an everolimus-eluting bioresorbable vascular scaffold (Absorb; 1,322 patients) or an everolimus-eluting cobalt-chromium stent (Xience; 686 patients). The primary end point was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at one year.
The researchers found that 7.8 and 6.1 percent of patients in the Absorb and Xience groups, respectively, had target-lesion failure at one-year (difference, 1.7 percentage points; P = 0.007 for noninferiority and P = 0.16 for superiority). No significant between-group differences were seen in the rates of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization. Device thrombosis occurred in 1.5 and 0.7 percent of patients in the Absorb and Xience groups, respectively, within one year (P = 0.13)
"Treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at one year," the authors write.
The study was funded by Abbot Vascular.