- Question
- Is an everolimus-eluting bioresorbable vascular scaffold noninferior to an everolimus-eluting metallic stent in patients with coronary artery disease?
- Design
- Multicenter, randomized (2:1), single-blind trial enrolling 2008 patients. The primary endpoint was assessed at 1 year, tested for both noninferiority and superiority.
- Population
- Patients with stable or unstable angina and noncomplex obstructive coronary artery disease, with de novo native coronary lesions.
- Intervention
- Implantation of an everolimus-eluting Absorb bioresorbable vascular scaffold (1322 patients).
- Control
- Implantation of an everolimus-eluting cobalt-chromium Xience metallic stent (686 patients).
- Primary outcome
- Target-lesion failure at 1 year, defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization. The noninferiority margin was 4.5 percentage points for the risk difference.
- Results
- Target-lesion failure occurred in 7.8% with Absorb and 6.1% with Xience (difference 1.7 percentage points; 95% CI, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There were no significant differences in cardiac death (0.6% vs 0.1%), target-vessel myocardial infarction (6.0% vs 4.6%), or ischemia-driven target-lesion revascularization (3.0% vs 2.5%).
- Safety
- Device thrombosis within 1 year occurred in 1.5% with Absorb and 0.7% with Xience (P=0.13).
- Conclusion
- The everolimus-eluting bioresorbable scaffold met the prespecified noninferiority margin versus the cobalt-chromium metallic stent for 1-year target-lesion failure.
- Why it matters
- This large-scale trial tested the idea that removing the persistent metallic frame from the vessel wall might improve long-term outcomes, and provided key early safety and efficacy data for this technology.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 15, 2026