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Early and Late Outcomes with the Absorb Bioresorbable Vascular Scaffold: Final Report f rom the ABSORB Clinical Trial Program ( JACC Cardiovascular Interventions January 2025)
Description


Background
. The risk-benefit ratio of the Absorb bioresorbable vascular scaffold (BVS) may vary before and after 3 years, the timepoint of complete bioresorption of the poly-L-lactic acid (PLLA) scaffold.


Objectives. We sought to determine the time-varying outcomes of Absorb BVS compared with cobalt-chromium everolimus-eluting stents (EES) from a large individual-patient-data pooled analysis of randomized trials.


Methods. We pooled the individual-patient-data from 5 trials that randomized 5,988 patients undergoing percutaneous coronary intervention (PCI) to Absorb BVS vs. EES with 5-year follow-up. The primary effectiveness and safety endpoints were target-lesion failure (TLF: cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization) and device thrombosis (DT), respectively.


Results. Between 0-5 years, TLF occurred in 15.9% BVS patients vs. 13.1% EES patients (HR, 1.25; 95% CI, 1.08-1.43; p=0.002) and DT occurred in 2.2% vs. 1.0% respectively (HR, 2.38; 95% CI, 1.49-3.79; p=0.0002). Between 0-3 years, TLF occurred in 12.4% BVS patients vs. 9.3% EES patients (HR, 1.35; 95% CI, 1.15-1.59; p=0.0002) and DT occurred in 2.0% vs. 0.6% respectively (HR, 3.58; 95% CI, 2.01-6.36; p<0.0001). Between 3-5 years, TLF occurred in 4.5% BVS patients vs. 4.7% EES patients (HR, 0.99; 95% CI, 0.76-1.27; p=0.91) and DT occurred in 0.2% vs. 0.4% of patients respectively (HR, 0.49; 95% CI, 0.18-1.38; p=0.17). By spline analysis the TLF hazard by 5 years was lower with BVS than EES.


Conclusions. Compared with EES treatment, BVS increased TLF and DT rates through 5-year follow-up. However, the period of excess risk for the first-generation Absorb BVS ended at 3 years when PLLA bioresorption is complete. Thereafter event rates were comparable or lower with BVS.

 

Editors

JACC: Cardiovascular Interventions Editor-in-Chief
David J. Moliterno, MD, FACC

JACC: Cardiovascular Interventions CME/MOC Editor
Michael C. McDaniel, MD

Authors

Gregg W. Stone, MD, FACC

Important Dates

Date of Release: January 13, 2025
Term of Approval/Date of CME/MOC Expiration: January 12, 2026

 

Summary
Availability: On-Demand
Access expires on Jan 12, 2026
Cost: FREE
Credit Offered:
1 CME Credit
1 ABIM-MOC Point
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