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

Area of Science:

• Cardiovascular Medicine
• Biomaterials Science
• Interventional Cardiology

Background:

• The risk-benefit profile of the Absorb bioresorbable vascular scaffold (BVS) may change after 3 years, coinciding with complete bioresorption of its poly-L-lactic acid component.
• Understanding the time-varying outcomes of BVS is crucial for clinical decision-making.

Purpose of the Study:

• To compare the time-varying outcomes of the Absorb BVS against cobalt-chromium everolimus-eluting stents (EES).
• To analyze data from a large pooled analysis of individual patient data from randomized trials.

Main Methods:

• Pooled individual patient data from 5 randomized trials involving 5,988 patients treated with Absorb BVS or EES.
• 5-year follow-up data were analyzed for primary endpoints: target lesion failure (TLF) and device thrombosis (DT).

Main Results:

• Between 0-5 years, BVS showed higher rates of TLF (15.9% vs 13.1%) and DT (2.2% vs 1.0%) compared to EES.
• Between 0-3 years, BVS had significantly higher TLF (13.5%) and DT (3.58%) rates.
• From 3-5 years, TLF (0.99) and DT (0.49) rates were comparable or lower with BVS compared to EES.

Conclusions:

• Absorb BVS is associated with increased TLF and DT rates through 5 years compared to EES.
• The period of excess risk for the first-generation Absorb BVS concluded at 3 years, post-bioresorption.
• After 3 years, event rates were comparable or lower with BVS, suggesting a potential shift in the risk-benefit balance over time.