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Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic

Gregg W Stone1,2, Takeshi Kimura3, Runlin Gao4

  • 1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

JAMA Cardiology
|September 28, 2019
PubMed
Summary

The first-generation Absorb bioresorbable vascular scaffold (BVS) showed increased risks of target lesion failure and device thrombosis up to 3 years. After 3 years, the excess risk period for BVS appears to end.

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Area of Science:

  • Cardiovascular Medicine
  • Biomaterials Science
  • Interventional Cardiology

Background:

  • Bioresorbable scaffolds (BVS) aim to offer clinical benefits post-resorption.
  • Early risks were noted with the Absorb BVS, but the long-term risk profile during bioresorption remained unclear.

Purpose of the Study:

  • To evaluate the outcomes of the first-generation Absorb BVS up to 5 years, specifically examining the period before and after 3 years, which marks complete bioresorption in animal models.
  • To compare the safety and effectiveness of BVS against metallic drug-eluting stents (EES) over a 5-year follow-up period.

Main Methods:

  • A meta-analysis of individual patient data from four randomized clinical trials comparing BVS with everolimus-eluting stents (EES) in 3384 patients with coronary artery disease.
  • Outcomes, including target lesion failure (TLF) and device thrombosis, were analyzed through 5-year follow-up, with specific examination of the intervals from 0-3 years and 3-5 years.

Main Results:

  • Through 5 years, BVS was associated with higher rates of TLF (14.9% vs. 11.6%) and device thrombosis (2.5% vs. 0.8%) compared to EES.
  • Between 0-3 years, BVS showed higher TLF (11.6% vs. 7.9%) and device thrombosis (2.4% vs. 0.6%).
  • Between 3-5 years, the rates of TLF (4.3% vs. 4.5%) and device thrombosis (0.1% vs. 0.3%) were similar between BVS and EES, with significant interaction P-values indicating a change in risk over time.

Conclusions:

  • The excess risk associated with the first-generation Absorb BVS concludes around the 3-year mark.
  • These findings offer insights into the temporal pattern of adverse events with BVS, highlighting challenges for bioresorbable technologies as alternatives to metallic stents.