Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program.

Summary

Pooled individual-patient data from 5 randomized trials (n=5,988) showed higher target lesion failure and device thrombosis with Absorb BVS vs EES through 3 years, but no excess risk between 3–5 years. Spline analyses suggest the hazard becomes comparable or lower after complete bioresorption, clarifying time-dependent safety of first-generation BVS.

Key Findings

• Between 0–5 years, TLF was higher with BVS vs EES (15.9% vs 13.1%; HR 1.25, 95% CI 1.08–1.43).
• From 0–3 years, device thrombosis was higher with BVS (2.0% vs 0.6%; HR 3.58, 95% CI 2.01–6.36).
• From 3–5 years, TLF was similar (HR 0.99) and device thrombosis numerically lower (HR 0.49) with BVS.

Clinical Implications

First-generation BVS should be avoided in favor of contemporary DES, but the findings support the potential of next-generation BRS if early hazards are mitigated. Long-term antithrombotic and imaging surveillance may be tailored to the time course of bioresorption.

Limitations

• Applies to first-generation Absorb BVS and may not generalize to newer scaffolds
• Heterogeneity in implantation techniques and trial eras may confound comparisons

Future Directions

Evaluate optimized implantation (PSP) and antithrombotic strategies for newer BRS; extend follow-up beyond 5 years; refine patient/lesion selection based on early risk mitigation.